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Process Engineer III

Proclinical Staffing
USA, Burlington, Massachusetts
Highly Competitive Salary
Start date
11 Nov 2022
Closing date
25 Nov 2022

View more

Manufacturing, Engineering, Process
Full Time
Contract Type
Experience Level
Experienced (non-manager)
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Job Details

Proclinical is seeking a Process Engineer located in Burlington, MA with a global manufacturing and research company. The Process Engineer will be responsible for facilitating the tech transfer of client processes and executing engineering functions including design and document controls.

This individual will also be expected to contribute toward continuous improvement initiatives in support of overall operational efficiencies and improved compliance.

Job Responsibility:

  • Develop batch records for client-specific formulation and filling / finish operations
  • Perform processing operations (ENG and GMP) including equipment preparation, bulk product formulation, sterile filtration, and filling support to facilitate process design and internal technology transfer.
  • Operate as an SME for GMP investigations (e.g. CAPA, departures, CCRs) as well as finalize closure reports for departures which are assigned to Process Engineering.
  • Direct client interaction, summarizing engineering-related work completed verbally as well as written. An Engineer level III will be required to undertake direct client interaction.
  • Identify and specify process specific equipment needed for client tech transfer, developing techniques and process parameters specific to the clients' product while maintaining critical product attributes.
  • Author instructions for the operation of equipment and for detailing process flows in clean room facility.
  • Develop new manufacturing and aseptic filling processes to meet client requirements.
  • Ability to troubleshoot, amend and accommodate the process of aseptic formulation and fill of drug product such that it harmonizes with Manufacturing Facility while protecting the integrity of client technology / product.
  • Responsible for maintaining 100% trained on engineering curricula
  • Will raise deviations in process to the attention of the shift supervisor, Engineering Management, and/or Quality Assurance
  • Understands and follows OSHA, HAZOP, and company procedures and guidelines when handling or disposing of hazardous materials and maintaining overall safety culture

Skills and Requirements:

  • B.S in scientific, engineering, or related field,
  • 7 year's experience in cGMP/FDA regulated environment
  • Aseptic technique, familiarity with clean room personnel/equipment flows is desirable
  • Knowledge of process flows - e.g. Disposables strategies, filtration, mixing strategies, fluid transfer to and from various vessels/biobags
  • Working knowledge of process engineering processing aids such as sanitary connections, valves, and pharmaceutical process design. Experience with CIP/SIP a plus.
  • Computer literate with good working knowledge of data analysis and design software (Minitab, JMP, Solidworks, VISIO) a plus.
  • Experience with particle size reduction techniques, such as extrusion, microfluidization, or homogenization.
  • Experience with lyophilization principles
  • Familiarity and understanding of cGMP's in a accordance with 21CFR210, and 21CFR211
  • Knowledge and understanding of the principles associated with aseptic filling technology (e.g. rotary piston/positive displacement pump, peristaltic pump systems).
  • Experienced in practicing Quality Risk Management per ICH Q9.
  • Ability to work with minimal amount of supervision; interact well with clientele as well as interdepartmentally.
  • Day Shift - 8 am - 5 pm with some flexibility

If you are having difficulty in applying or if you have any questions, please contact Anne Luu at (+1) 215-660-3637 or

Proclinical is a specialist employment agency and recruitment business, providing job opportunities within major pharmaceutical, biopharmaceutical, biotechnology, and medical device companies.

Proclinical Staffing is an equal opportunity employer.



At ProClinical we have one aim: to support life science companies in the many challenges they face while combatting unmet medical need worldwide.

Ageing populations, rare diseases, epidemics and the millions of patients without access to medication are just a few of the pressing issues that life science companies contend with. The industry is under increasing pressure to develop new and innovative ways to save and improve patients’ lives. 

ProClinical’s mission is to support their work by connecting life science companies with the highly skilled professionals they need to continue innovating. 

Internal recruitment and HR teams often struggle to continuously source skilled, experienced professionals to fill highly-specialised and niche roles. ProClinical combines a deep understanding of the industry with extensive candidate networks to provide both a technical and cultural fit for our life science partners.


Find Us
0800 988 4437
Eldon House
Eldon Street
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