Engineering / Facilities

Engineering Technician Direct Hire MA

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Job ID: 15240 Direct Hire MA

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A high-profile, innovative, fully-integrated medical device company is looking for a motivated Engineering Technician to join their growing team! Come support diverse, cutting-edge product lines from a production standpoint and work collaboratively with other functional teams!

This hands-on role will focus on production testing failures and production support, SOPs and training materials, and return merchandise authorizations (RMA) for their product lines. It's an opportunity to work with engineers for prototyping, troubleshooting and soldering down to the component level on circuit boards, and testing systems.

Qualified candidates will have 3-5+ years of related experience. An Engineering technician, Associate's, or Bachelor's degree is required. Any basic knowledge of C/C++ and/or electrostatic discharge is a plus. Must be able to work with minimal supervision.

Must be authorized to work in the US indefinitely to be considered. All resumes will be kept strictly confidential until you choose to pursue a specific opportunity with one of our clients. Formal descriptions can be supplied for interested candidates.

Automation Engineer Direct Hire MA

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Job ID: 15217 Direct Hire MA

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Global cGMP Biologics company here in MA is looking to add an Automation Engineer to their Metro-West MA team!  Automation Engineer will be responsible for developing and implementing the automation solution for a new biologics manufacturing site. This role works independently, with minimal supervision and direction. Projects may often require independent decision making and exercising of judgment. Project work is generally prioritized by the group manager or lead engineers.

  • Support the configuration, administration and maintenance activities of the site’s manufacturing computer and automation systems, including process control systems, building automation systems, and data historians. Design, configuration, and testing of MES elements including master batch records, master data, system configuration, and interfaces.
  • Lead projects in the design, development, and qualification of automated processes, equipment, and systems; including managing the work of internal engineers and outside vendors.
  • Identify opportunities to improve existing process, equipment, systems, and infrastructure.
  • Directly support operations with troubleshooting and issue resolution with respect to computer and automation systems.
  • Lead small cross functional teams in support of project requirements and initiatives.
  • May have technical leadership or supervisory responsibilities over more junior engineers.
  • Required to be part of on-call rotation for off-hours manufacturing support after project go-live.
  • Requires working in an industrial manufacturing environment including gowning.

Requirements:

  • Bachelor's degree AND 7+ years of relevant cGMP work experience OR Masters with 5+ years. 
  • Experience with some of the following platforms: DeltaV, Allen Bradley PLC, OSI Soft PI historian, Werum PAS/X, Instrumentation and/or control panel hardware. 
     

Sr. Process Engineer for Commercial Biologics Direct Hire MA

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Job ID: 15189 Direct Hire MA

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Our client is a global Fortune 500 company with a large clinical & commercial biologics campus located in the suburbs of Boston and Cambridge.  Come join
their growing Engineering Group to ensure that the manufacturing equipment/systems are safe and fit for purpose. This encompasses work processes that
originate with the identification of new or revised assets; the design, installation, verification and validation of the assets; the maintenance of the assets in their
commissioned/qualified/validated states; and the retirement of the assets at the end of their life.

The main function of this role is to lead the engineering support of manufacturing, maintenance and capital projects.  

Responsibilities include but are not limited to;
•  Lead initiatives and/or projects and lead a small group of engineers and/or technicians on an ongoing or project basis.
•  Function as a technical expert on equipment or systems; lead troubleshooting of operations, develop preventative maintenance procedures, and maintain
engineering documentation.
•  Routinely audit the operational performance and regulatory compliance of a variety of equioment and systems used in the production of complex biologic
therapeutics
•  Lead efforts with manufacturing, process development, facilities, quality assurance and other departments in developing requirements and recommendations
for system modifications.
•  Support the design, engineering, construction, commissioning, and qualification for projects within schedule and budget constraints.
•  Coordinate the work of consultants and engineering firms on development of standard design documents.
•  Develop project scopes, schedules and budgets.
•  Obtain and critique quotes for system/facility modifications and work with vendors to execute.
•  Ensure Inspection Readiness of assigned areas
•  Participate in timely completion of investigations, deviations and CAPA and develop and manage change controls

Formal descriptions can be supplied for interested candidates. 

Qualified candidates will have a BS or MS degree in an Engineering discipline (Chemical Engineering, Mechanical Engineering, etc.) and several years of
industry experience.  Title will be commensurate with experience.  Typically for Sr. Engineer, a BS degree with 8+ years or MS with 5+ years of experience will
be required.  Ideal candidates will have a working knowledge of pharmaceutical/biotech process and equipment, general understanding of Quality Systems, and
a general knowledge of Commissioning and Qualification.

Must be authorized to work in the US indefinitely to be considered.   

All resumes will be kept strictly confidential until you choose to pursue a specific opportunity with one of our clients.

Sr. Process Engineer for Commercial Biologics Direct Hire MA

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Job ID: 15184 Direct Hire MA

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Our client is a global Fortune 500 company with a large clinical & commercial biologics campus located in the suburbs of Boston and Cambridge.  Come join their growing Engineering Group to ensure that the manufacturing equipment/systems are safe and fit for purpose. This encompasses work processes that originate with the
identification of new or revised assets; the design, installation, verification and validation of the assets; the maintenance of the assets in their commissioned/qualified/validated states; and the retirement of the assets at the end of their life.

The main function of this role is to lead the engineering support of manufacturing, maintenance and capital projects.  

Responsibilities include but are not limited to;
•  Lead initiatives and/or projects and lead a small group of engineers and/or technicians on an ongoing or project basis.
•  Function as a technical expert on equipment or systems; lead troubleshooting of operations, develop preventative maintenance procedures, and maintain engineering documentation.
•  Routinely audit the operational performance and regulatory compliance of a variety of equioment and systems used in the production of complex biologic therapeutics
•  Lead efforts with manufacturing, process development, facilities, quality assurance and other departments in developing requirements and recommendations for system modifications.
•  Support the design, engineering, construction, commissioning, and qualification for projects within schedule and budget constraints.
•  Coordinate the work of consultants and engineering firms on development of standard design documents.
•  Develop project scopes, schedules and budgets.
•  Obtain and critique quotes for system/facility modifications and work with vendors to execute.
•  Ensure Inspection Readiness of assigned areas
•  Participate in timely completion of investigations, deviations and CAPA and develop and manage change controls

Formal descriptions can be supplied for interested candidates. 

Qualified candidates will have a BS or MS degree in an Engineering discipline (Chemical Engineering, Mechanical Engineering, etc.) and several years of industry experience.  Title will be commensurate with experience.  Typically for Sr. Engineer, a BS degree with 8+ years or MS with 5+ years of experience will be required.  
Ideal candidates will have a working knowledge of pharmaceutical/biotech process and equipment, general understanding of Quality Systems, and a general knowledge of Commissioning and Qualification.

Must be authorized to work in the US indefinitely to be considered.   

All resumes will be kept strictly confidential until you choose to pursue a specific opportunity with one of our clients.

Director, Technical Operations - Biologics Direct Hire MA

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Job ID: 15161 Direct Hire MA

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Global Pharmaceutical company here in MA is seeking Director, Technical Operations – Biologics!  Director will develop strategic plans, align functions and business partners, and provide transparency of performance, within the organization. Will contribute to the development, socialization, and deployment of processes to define, prioritize, and manage initiatives across the Biologics project portfolios. Working to ensure processes are efficient and effective, in supporting the manufacture and delivery of high quality products on a global level.  Other responsibilities include but not limited to:

  • Develop and Manage Project Prioritization Process in collaboration with  the Program Management Office.
  • Partner with PMO on the planning thru deployment and maintenance of global standards.
  • Support/Lead Initiatives: Due Diligence, Integration, Make vs. Buy Site Evaluations and Selections, Continuous Improvement, Transformation, Technology Transfer, New Product Introductions, etc.
  • Develop, Deploy, and Maintain Business Processes (Project Prioritization and Monitoring, Operations Performance, Knowledge Management (KM), Records Information Management (RIM), etc.).
  • Oversee budgets, request purchase orders (POs), and process change orders.
  • At times may independently execute a request for proposal (RFP) or negotiate moderate scope manufacturing supply agreements, meeting supply, quality, financial and risk mitigation requirements.
  • Establish, track, monitor, and report performance metrics related to operations, quality, cost, and customer service.
  • Apply understanding of business operations needs with regard to the Tech Ops Biologics team; Develop a plan with facilities, Process Development, CMC teams and other key stakeholders to meet program needs, such as supply assurance, life cycle management, process improvements, COGs reduction, continuous improvement, and increase efficiencies

Requirements:

  • B.S. degree or higher in a Technical Discipline AND 15+ years relevant pharmaceutical industry experience. 
  • Strong technical operations (process development, manufacturing, engineering, quality) experience
  • Experienced in interfacing with and managing cross-functional teams globally in a matrix environment
  • Demonstrated abilities in project/program management associated with cross-functional, global teams
  • Experience in developing and/or evaluating feasibility assessments of projects/technologies/assets - taking into account technical and business aspects.
  • Ability to effectively communicate and influence at all levels of the organization
  • Experienced in risk management processes

Director, Drug Product Manufacturing Direct Hire MA

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Job ID: 15122 Direct Hire MA

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Growing, Mid-Size Biologics company here in Cambridge, MA is looking to bring on board a Director, Drug Product Manufacturing!  This role will drive the strategy for late-stage and early-stage clinical development programs and lead the manufacturing operations group.  Director will apply manufacturing concepts, tools and practices and act as the first-line resource to manage the interface between other CMC, Quality, Regulatory, Clinical, and other functions and to align the functional strategy and with program, portfolio, and corporate goals.  Other responsibilities include but not limited to:

  • Facilitate/lead tech transfers for early and late stage clinical programs to/from CMOs and participate in the customer interface as required.
  • Develop and mentor a high-performing team with a vision of setting industry-leading standards in this nascent field.
  • Build processes and relationships with external and internal development and manufacturing organizations.
  • Identify risks and drive continuous improvement in the manufacturing process through technological innovation and alignment with regulatory and commercial manufacturing requirements.
  • Actively engage in the identification, sharing and adaptation of best practices cross-functionally and between manufacturing sites. Implement/support business process for continuous improvements.
  • Drive functional compliance to regulatory requirements, and quality systems in a GMP environment.
  • Author, review, and approve CMC documentation for regulatory filings as well as attending pertinent regulatory meetings as the functional owner.

Requirements:

  • A PhD in the pertinent life sciences or advanced degree, with 10+ year’s relevant industry experience.
  • Experience managing a broad organization as well as external manufacturing providers, partners, and or academic collaborations is required.
  • Proven track-record of successfully integrating activities and perspectives across functions
  • Ability and track record of successfully managing biologics programs through late-stage clinical development is required.
  • Thorough working knowledge of cGMP manufacturing.
  • Technology transfer and extensive CMO experience is required.
  • Strong interpersonal skills with the ability to motivate others, influence, and negotiate conflict situations.
  • Able to Travel 20-30%

Principal Engineer - Acoustic Technologies (RF or Ultrasonic) Direct Hire MA

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Job ID: 14960 Direct Hire MA

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Our client is a Fortune 1000 company with broad capabilities in filtration, separation and purification.  They are seeking an experienced Engineer with familiarity with RF Electronics, FPGA development, Piezo Electronics, and Acoustic Controls.  

The main function of this role is to develop electronics for laboratory and production scale systems for the Biopharmaceutical market.  In this role, you will serve as lead electrical engineer for development or improvement from an early phase, managing specification, design, prototype and test, prior to industrialization and transfer to manufacturing.  This role will focus on developing electronics in parallel with process / system development in a R&D environment.

Responsibilities include but are not limited to;
•  Interact with and support supply chain, quality, logistics, external vendors and product management groups to facilitate development
•  Be a resource for ongoing development projects by leading prototype design, build, and testing
•  Transferring qualified design packages to engineering group for customer configuration
•  Providing ongoing expertise for technical problem solving post-launch
•  Travel will vary according to project needs (typically 15% or less yearly), both domestically and in Europe. 

Formal descriptions can be supplied for interested candidates. 

Qualified candidates will have a BS degree or higher in an Engineering discipline and 10+ years of industry experience.  Preference for those with familiarity with the biopharmaceutical industry and applicable security regulations for automated products such as 21 CFR part 11 and/or experience with developing products for use in GMP environments including a working knowledge of GAMP 5 development strategies.  Familiarity with common communications protocols such as OPC-DA/UA and Modbus (serial and Ethernet) also highly desirable.  

Must be authorized to work in the US indefinitely to be considered.  All resumes will be kept strictly confidential until you choose to pursue a specific opportunity with one of our clients.