Engineering / Facilities

Principal Process Equipment Engineer (Reliability) Direct Hire MA

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Job ID: 15339 Direct Hire MA

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Exciting Process Equipment Engineering (Reliability) role with Global Pharmaceutical Company here in Massachusetts!  The Principal Reliability Engineer will be responsible for enhancing the reliability of process equipment and maintenance processes through applying the principles of Reliability Centered Maintenance. This role will mentor staff, apply Root Cause Analysis methodologies to improve equipment that support manufacturing operations and measure reliability performance.  Principal will be involved with engineering and maintenance process improvements, capital projects, lead cross-functional reliability improvement projects and set priorities for improvement projects.  Other responsibilities include:

  • Identify, develop and present business cases to management for Reliability Improvement projects and participate in capital planning in assigned area(s).
  • Supervise technical teams and contractors.
  • Supervise and mentor junior staff in Process Improvement and Reliability Engineering principles, methodologies and tools.
  • Lead Failure Mode Effect Analysis (FMEA) & Root Cause Failure Analysis (RCFA).
  • Lead Reliability Centered Maintenance Improvement (RCM) projects in multiple areas.
  • Participate and provide support for audits.
  • Lead the implementation of predictive maintenance across the facility.
  • Provide reliability engineering subject matter expertise in the development of design specifications and standards, global engineering and maintenance business practices.
  • Provide Reliability Engineering subject matter expertise to design teams, during the design review and selection of new and modified equipment.
  • Lead / Participate in FAT, Commissioning of new and modified equipment.
  • Participate in industry forums related to maintenance and reliability

Requirements:

  • BS degree in an Engineering discipline and 8+ years of industry experience, including cGMP Pharmaceuticals.
  • Must have knowledge of CMMS and engineering & maintenance business practices / procedures.
  • Must proficient possess knowledge of laboratory and pharmaceutical production and support equipment including cell culture and purification process equipment.
  • Experience with Reliability Centered Maintenance (RCM) and/or Total productive Maintenance (TPM).
  • Must have knowledge of process improvement and reliability engineering principles, methodologies and tools such as PDCA, LEAN, Six Sigma / DMAIC, RCFA, FMEA.
  • Must be able to organize and present technical and project management plans and schedules without assistance.

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, 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.