- Strategic Leadership: Develop and implement manufacturing strategies aligned with the company's goals and objectives. Provide visionary leadership to the manufacturing team, fostering a culture of excellence, collaboration, and accountability.
- Operational Oversight: Manage all aspects of the manufacturing process, including production planning, resource allocation, and process optimization. Ensure the timely and efficient production of high-quality therapeutics.
- Compliance and Quality: Ensure compliance with all regulatory requirements, including GMP (Good Manufacturing Practices) and other relevant guidelines. Oversee quality assurance and control processes to maintain product integrity and safety.
- Team Management: Lead, mentor, and develop a high-performing manufacturing team. Foster a positive work environment and provide guidance and support to team members to achieve departmental and organizational goals.
- Continuous Improvement: Identify opportunities for process improvements and implement best practices to enhance manufacturing efficiency, reduce costs, and improve product quality.
- Cross-Functional Collaboration: Work closely with other departments, including R&D, Quality Assurance, Supply Chain, and Regulatory Affairs, to ensure alignment and address any issues that may impact manufacturing operations.
- Budget Management: Develop and manage the manufacturing budget, ensuring cost-effectiveness and alignment with financial goals. Monitor and report on financial performance and operational metrics.
- Problem Solving: Address and resolve manufacturing-related issues promptly and effectively. Implement corrective and preventive actions to mitigate risks and enhance process reliability.
- Education: Bachelor’s degree in Engineering, Life Sciences, or a related field. Advanced degree (Master’s or PhD) preferred.
- Experience: Minimum of 10 years of experience in therapeutic manufacturing, with at least 5 years in a leadership role. Proven track record in managing complex manufacturing operations and teams.
- Knowledge: In-depth knowledge of GMP regulations, regulatory requirements, and industry best practices. Strong understanding of manufacturing technologies and processes for therapeutic products.
- Skills: Exceptional leadership, communication, and interpersonal skills. Ability to drive change and manage multiple projects simultaneously. Strong analytical and problem-solving abilities.
- Certifications: Relevant certifications (e.g., Six Sigma, Lean Manufacturing) are a plus.
- Innovative Environment: Work with cutting-edge technology and contribute to the development of groundbreaking therapeutics.
- Career Growth: Opportunities for professional development and career advancement.
- Collaborative Culture: Be part of a supportive and collaborative team that values your expertise and ideas.
- Competitive Compensation: Attractive salary and benefits package.
The Components Engineer will play a critical role in the design, development, and testing of components and subsystems for space vehicles. This individual will collaborate with a cross-functional team of engineers, scientists, and technicians to ensure the reliability, performance, and safety of these components in the demanding environment of space.
Responsibilities:
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Component Selection and Design:
- Conduct in-depth research and analysis to identify suitable components for space vehicle applications.
- Develop component specifications and design criteria based on mission requirements and industry standards.
- Evaluate component performance, reliability, and compatibility with the overall space vehicle system.
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Component Testing and Qualification:
- Design and conduct rigorous testing programs to assess component performance under simulated space conditions.
- Develop test procedures and protocols to evaluate component reliability, durability, and environmental resistance.
- Analyze test data to identify potential design flaws or performance issues.
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Component Integration and Verification:
- Ensure seamless integration of components into the overall space vehicle system.
- Develop verification plans and procedures to validate component functionality and performance.
- Conduct system-level testing to assess component interactions and compatibility.
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Failure Analysis and Root Cause Investigation:
- Investigate component failures and conduct root cause analyses to identify underlying issues.
- Implement corrective actions to prevent recurrence of failures and improve component reliability.
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Documentation and Reporting:
- Prepare detailed technical documentation, including component specifications, test reports, and engineering analyses.
- Generate comprehensive reports summarizing component development, testing, and performance.
Qualifications:
- Bachelor's degree in Mechanical Engineering, Aerospace Engineering, or a related field.
- Minimum of 5 years of experience in component design, testing, or analysis, preferably in the aerospace or related industry.
- Strong understanding of engineering principles, materials science, and manufacturing processes.
- Proficiency in CAD software (e.g., SolidWorks, AutoCAD) and engineering analysis tools (e.g., FEA, CFD).
- Excellent problem-solving, analytical, and troubleshooting skills.
- Strong attention to detail and ability to work independently and as part of a team.
- Experience with space vehicle systems and components is a plus.
Desired Skills:
- Knowledge of space environment and its effects on components.
- Experience with component qualification standards (e.g., ECSS, NASA).
- Familiarity with reliability engineering and failure analysis techniques.
- Programming skills (e.g., Python, MATLAB)
- 6 years of related experience
- 4+ years of related experience in Distributed Application Support.
- Hands on experience in Distributed Application Support, built in Java/J2EE, XML, HTML, Java Script, NodeJS platforms.
- Hands on experience in Unix, Linux, Windows, SQL/PLSQL
- Mainframe troubleshooting and support skills (COBOL, JCL, DB2, DB2 Stored Procedures, CICS, SPUFI, File aid)
- Mainframe scheduling (Job abends, Predecessor/Successor)
- Complete the pre-production/production application code deployment plans and end to end vendor application upgrade process (e.g. SNOW, SF, etc)
- Aligns risk and control processes into day to day responsibilities to monitor and mitigate risk; advances appropriately
- The Database Engineering team is responsible for managing public and private cloud databases and responsible for the design, build, and operational aspects of the database.
- The Director Database Engineering is responsible for leading the database team and will be responsible for the strategy, design, implementation, and operations of database solutions.
- You and your team will engage with the infrastructure and application development teams and support the adoption of cloud database solutions and provide a clear path to migrate from the private cloud to the public cloud.
- Lead engineering and support teams that will support modernization efforts.
- Collaborate and align with the modernization plans of the platform and application development teams.
- Create a mature distributed database service (i.e. Oracle, Aurora PostgreSQL) that is attuned to the customer’s needs by promoting self-service capabilities.
- Extensive involvement in audit and regulatory reviews for all items related to the cloud database space.
- Encourage & lead automation initiatives for public and private cloud databases.
- Strong people leadership to empower, encourage, and engage.
- Bachelor’s degree and/or equivalent experience
- Minimum of 10 years of related experience of database engineering, delivery, and support.
- Ability to work across teams to create partnerships that achieve organization goals, and passionate about building an innovative culture.
- Ability to technically lead the cloud database technology team along with providing transparency and insight that can be consumed by business teams.
- Proven understanding of AWS cloud database technologies.
- Passionate about building a strong team to support the organization’s goal for modernization.
- Solid understanding of automation and orchestration tools such as Terraform, Ansible, and GitLab.
- Familiarity with Software Development Life Cycle management & the Agile methodology.
- 8 years' experience architecting and implementing ServiceNow ITOM capabilities at multiple organizations
- Lead the strategy and design of ServiceNow ITOM initially focusing on discovery data integration into the CMDB
- Maintaining and enhancing existing ServiceNow discovery and experience with discovery in a hybrid environment
- Initial deployment(s) of ServiceNow discovery
- Be and SME (Subject Matter Expert) various company-wide and IT initiatives which have a CMDB impact (SME-level understanding of ServiceNow CMDB hierarchy)
- Common Service Data Model (CSDM)
- ITIL Certified (Foundation v3 or v4)
- ServiceNow Discovery Certification
- Regulated Industry
- Certifications: Service Mapping and/or AWS certification
- We have a Controls Engineer position available in our Addison, TX office. This position requires demonstrated technical proficiency in implementing automation solutions with PLC, HMI, SCADA, and DCS/Delta V platforms.
- This person will interact directly with the customer and lead a team of Wunderlich-Malec engineers in identifying requirements, developing specifications, and implementing/testing/commissioning/qualifying automation solutions.
- This position is a leadership role within the business unit and requires strong problem-solving ability, well-balanced people skills, an aptitude for business efficiency, and an interest in creating partnerships.
- The Mid- or Senior Controls Engineer demonstrates success by securing repeat work with both new and existing customers.
- This position requires the ability to deliver innovative automation solutions and design standards either self-directed or as a leader of a team. The candidate must have the ability to conceptualize, detail, and implement control systems for industrial processes and machinery that meet our customer’s requirements. This involves the development of a control system architecture, selecting the components to be used, detailing schematic diagrams and system documentation, programming controllers (PLC, DCS/Delta V), programming the process visualization (HMI/SCADA), developing databases for archiving/displaying historical system data and implementing/commissioning the control system at the client’s facility. Knowledge of controller programming languages such as Ladder, Sequential Function Chart, Structured Text, and others to achieve the desired results is required. Also having knowledge of standard programming languages such as VBA, .NET, and SQL and Python for the development of HMI/SCADA systems is preferred.
- For larger systems, experience with industrial networking used to connect control system components and instrumentation is preferred. The Controls Engineer would design, detail, and implement a variety of fiber, wired and wireless systems using industrial protocols (Ethernet/IP, Profinet, Modbus, etc.)
- This position oftentimes requires the following project management responsibilities: developing project execution plans, work breakdown structures and associated budgets, task prioritization and scheduling, task ordering, time tracking and reporting, financial tracking and reporting, early problem identification, conflict management/resolution, leading and supporting a team, and attending project status meetings. Also includes overseeing daily operations and activities of a project(s) up to $10M. This position is often responsible for ensuring the overall profitability of the project.
- The ideal candidate must have a diverse engineering skillset with the ability to work independently. Will act as technical lead on projects and guide lower-level engineers and technicians. Could also act as Project Manager on smaller projects.
- Education – Bachelor of Science degree in Electrical/Control Engineering, Mechanical Engineering, Chemical Engineering, or Computer Science or equal experience.
- Experience – Greater than 8 years with capabilities in below areas is preferred:
- In-depth understanding of Emerson DeltaV platform.
- Experience in PLC-5 to ControlLogix conversions.
- In-depth understanding of PLC hardware/software platforms such as Rockwell Automation, Siemens, and Modicon.
- In-depth understanding of HMI/SCADA hardware/software platforms such as Servers, VM’s, Networks, Rockwell Automation FactoryTalk and Plant Pax, Aveva System Platform and Edge, Inductive Automation Ignition, GE iFIX, Siemens Winn CC and TI Portal.
- Understanding of DCS hardware/software platforms such as Emerson DeltaV or similar.
- Project Management experience with a PMP certification a plus.
- Understanding of Batch/Recipes, OEE, MES, and ERP systems.
- Experience in industries such as Semiconductor, Life Sciences, Building Automation, Food and Beverage, Water Treatment, and general manufacturing.
- Experience in the design of electrical schematics, and control panels including power distribution under 480VAC, and associated NEC references desired.
- Experience with AutoCAD is also desired.
- Experience leading a team of engineers/technicians to provide control system solutions.
- Experience mentoring less experienced engineers.
- Professional references, preferably one from each of the following: a subordinate, a peer, and a manager.
- Examines equipment, processes, operations, and procedures to identify improvement opportunities in areas of safety, quality, throughput, and cost.
- Implement changes and modify operation standards.
- Evaluate vendor proposals for new equipment purchases.
- Select & implement suitable manufacturing processes and apply modern organizational principles to make products at a competitive cost.
- Identify & optimize current and new manufacturing processes using continuous improvement.
- Work closely with production and maintenance to ensure equipment is operating in a like-new condition.
- Conduct Capability Studies and perform Time Studies.
- Process Development – may include Visual Work Instructions.
- Production support and process troubleshooting.
- Cost (scrap, rework, cycle time, etc.) reduction.
- Specify tools, jigs and fixtures.
- Project coordination and daily troubleshooting.
- Participate in Kaizen events.
- BS in Material Science, Mechanical, Welding, Manufacturing or Industrial Engineering or combined related experience required.
- 2-4 years engineering project experience in a metal manufacturing.
- Experience in Lean manufacturing techniques, capability studies, process mapping, FMEA, and root cause analysis.
- Must be capable of taking a project lead role and comfortable in a fast-moving continuous improvement culture.
- Excellent verbal and written communication skills.
- Must be able to manage multiple tasks with aggressive deadlines.
- The ideal candidate is detail orientated and can understand complex process interactions.
- Must be computer literate and familiar with Microsoft Office.
- Creo & AutoCAD a strong plus.
- BS in Material Science, Mechanical, Welding, Manufacturing or Industrial Engineering or combined related experience required.
- 2-4 years engineering project experience in a metal manufacturing is preferred.
- Experience in Lean manufacturing techniques, capability studies, process mapping, FMEA, and root cause analysis.
- Experience in Creo & AutoCAD and MS Office.
- We have a Sr. Automation Engineer position available in our Wilmington, MA office. This position requires demonstrated technical proficiency in implementing automation solutions with PLC, DCS, HMI, and SCADA platforms.
- This position requires demonstrated technical proficiency in implementing automation solutions with PLC, DCS, HMI, and SCADA platforms.
- The Senior Controls Engineer will interact directly with the customer and lead a team of Wunderlich-Malec engineers in identifying requirements, developing specifications, and implementing/testing/commissioning/qualifying automation solutions.
- This position is a leadership role within the business unit and requires strong problem-solving ability, methodical project management skills, well-balanced people skills, an aptitude for business efficiency, and an interest in creating partnerships.
- The Senior Controls Engineer demonstrates success by securing repeat work with both new and existing customers.
- This position requires the ability to deliver innovative automation solutions and design standards either self-directed or as a leader of a team. The candidate must have the ability to conceptualize, detail and implement control systems for industrial processes and machinery that meet our customers’ requirements. This involves the development of a control system architecture, selecting the components to be used, detailing schematic diagrams and system documentation, programming controllers (PLC, DCS, RTU), programming the process visualization (HMI/SCADA), developing databases for archiving/displaying historical system data and implementing/commissioning the control system at the client’s facility. Knowledge of controller programming languages such as Ladder, Sequential Function Chart, Structured Text, and others to achieve the desired results is required. Also having knowledge of standard programming languages such as VBA, .NET, and SQL for the development of HMI/SCADA systems is preferred.
- For larger systems, experience with industrial networking used to connect control system components and instrumentation is preferred. The Senior Controls Engineer would design, detail, and implement a variety of fiber, wired and wireless systems using industrial protocols (Ethernet/IP, Profinet, Modbus, etc.).
- This position oftentimes requires the following project management responsibilities: developing project execution plans, work breakdown structures, and associated budgets, task prioritization and scheduling, task ordering, time tracking, and reporting, financial tracking and reporting, early problem identification, conflict management/resolution, leading and supporting a team, and attending project status meetings. Also includes overseeing daily operations and activities of a project(s) up to $1M. This position is often responsible for ensuring the overall profitability of the project.
- The ideal candidate must have a diverse engineering skillset with the ability to work independently. Will act as technical lead on projects and guide lower-level engineers and technicians. Could also act as a Project Manager on smaller projects.
- Education – A Bachelor of Science degree in Electrical/Control Engineering, Mechanical Engineering, Chemical Engineering, or Computer Science is required.
- Greater than 10 years with capabilities in below areas is preferred:
- In-depth understanding of PLC hardware/software platforms such as Rockwell Automation, Siemens, and Modicon.
- In-depth understanding of HMI/SCADA hardware/software platforms such GE iFIX, Rockwell Automation FactoryTalk View, Inductive Automation’s Ignition, and Siemens.
- In-depth understanding of DCS hardware/software platform such as Emerson DeltaV, Rockwell PlantPAx, or similar.
- Familiarity with electrical schematics, including power distribution under 480VAC, control panels, and associated NEC references desired.
- Experience with AutoCAD is also desired.
- Experience leading a team of engineers/technicians to provide control system solutions.
- Experience mentoring less experienced engineers.
- Proven experience in managing, leading and guiding automation design and implementation projects in the Life Science industry.
- Proven experience with all phases of automation projects including conceptual, basis of design, implementation, testing, start-up and commissioning of Process Control System (PCS), SCADA, and DCS in the Life Science industry.
- Strong knowledge of S88 Batch
- Familiarity with relevant regulatory requirements of the life science industry such as cGMP, 21 CFR Part 11, etc.
- Familiarity with GAMP5, System and Software Development Life Cycles methodologies, validation
- Strong knowledge of IT/OT networking
- Extensive knowledge of automation protocols such as HART, Foundation Fieldbus, Traditional I/O, Profibus, Ethernet I/P, OPC, Modbus TCP/IP, etc.
- Experience with relational databases such as SQL, Oracle, etc.
- Excellent technical writing and verbal communication skills
- Professional references, preferably one from each of the following: a subordinate, a peer, and a manager.
- Master’s degree in quantitative disciplines.
- 5 years of experience in financial market risk management and quantitative modeling.
- Solid advanced math/statistics knowledge.
- Strong analytical skills and innovative problem-solving skills.
- Fluency in at least one high level programming language (Python, C++, Java, etc.) and familiarity with SQL.
- Experience modeling fixed income, including treasury or mortgage security
- Excellent communication skills, both oral and written.
- Ability to deliver quality, precise work product on time.
- Strong drive and intrinsic motivation and thrives under pressure and time constraints.
- Minimum of 6 years of related experience
- Bachelor's degree preferred or equivalent experience.
- 6+ Years of active development experience/ expertise in Java/J2EE based applications demonstrated ability with Hibernate, Spring boot, Spring MVC
- Strong frontend framework experience - Angular
- Experience with CSS, HTML, JavaScript
- Exposure to XML/XSD, JSON and similar data presentation components
- Familiarity with Microservices based architecture and distributed systems.
- Ability to develop and work with REST APIs using Spring Boot framework.
- Experience with CI/CD technologies like GIT, Jenkins, JoCoCo and Maven
- Strong database and PL/SQL skills (Oracle, snowflake preferred)
- Experience with containers is a plus.
- Experience with Messaging, ETL or Reporting tools is a plus.
- Knowledge of Python a plus
- Familiarity with Agile development methodology
- Experience with Code coverage, JUnit, Mockito, PowerMock
- Experience with static code analysis tool - SonarQube
QC Inspector / Certified Welding Inspector
The Q.C Inspector shall demonstrate substantial knowledge of processes, codes, and job specifications and can perform routine Q.A/Q.C product inspections as required. The Q.C inspector shall be knowledgeable in Q.A/Q.C equipment operations and associated documentation of inspections and testing.
Knowledge, Skills & Abilities
Demonstrated ability to perform each duty and responsibility satisfactorily
Ability to read and comprehend simple instructions, short correspondence and memos
Ability to write simple correspondence
Ability to effectively present information in one-on-one and small group situation to other employees of the organization
As needed the employee should have sufficient education, training, and experience to ensure qualification in inspection methods, which are being employed
Ability to apply common sense understanding to carry out detailed but uninvolved written or oral instructions
Ability to deal with problems involving a few concrete variables in standardized situations
Ability to add, subtract, multiply, and divide in all units of measure, using whole numbers, common fractions and decimals
Ability to compute rate, ratio, percent and to draw and interpret bar graphs
Ability to locate and compute metric conversions
Education/Experience
High School diploma or general education degree (GED); or
One to three months related experience and/or training; or
Equivalent combination of education and experience.
Job Shop Machine experience
Certified Welding Inspector (CWI)
- Improve overall processes and related issues including process development
- Schedule and create process documentation
- Problem solving and program management
- Design, installation, and debug of tooling and capital equipment
- Obtain tooling quotes and coordinate sourcing, build and try-out
- Develop and troubleshoot stamping processes
- Specify forming and stamping equipment
- Provide engineering resources for other departments as required
- Follow quality systems procedures as required
- Design and develop manufacturing tooling and fixtures
- Provide tool construction personnel with sketches and instructions
- Investigate and analyse tooling, processing, assembly and sequencing issues
- Initiate corrective actions to include the modification of plant tooling and machine programming
- Work closely with product and process teams to design, install, and launch robust processes including process 'sign off' activities and production pilots
- Participate in problem resolution teams
- Develop specifications and analyse supplier quotations for purchase of new production equipment up to and including entire manufacturing lines
- Daily troubleshooting of assembly and press shop problems to support production
- Liaison with R&D to ensure manufacturability of components prior to release
- Contact person for ECN (Engineering Change Notice) implementation
- Other duties as assigned
- CAD experience required
- i.e.: AutoCAD, Pro E, Solid Works
- Journeyman Tool and Die experience a plus
- Die Design experience a plus
- Knowledge of design applications- stamping and molding
- Knowledge of equipment and systems appropriate to related discipline
- Knowledge of engineering principles and procedures
- Skill in applying engineering principles and procedures
- Skill in engineering design applications
- Ability to effectively communicate
- The desire to strive for both personal and operational excellence through a never-ending drive for continuous improvement
- Committed to achieving world-class performance standards
- Bachelor’s degree in engineering or related field OR 8 years of equivalent experience
- Any equivalent combination of experience, training and/or education approved by Human Resources
- Position involves sitting long periods, standing, manual dexterity, stooping, bending and minimal lifting
- Bachelor’s degree in engineering or related field OR 8 years of equivalent experience.
- Experience in CAD i.e.: AutoCAD, Pro E, Solid Works.
- Journeyman Tool and Die experience
- Die Design experience
- Metal stamping exp. as it relates to tooling