Process Engineer

Proclinical is seeking a Process Engineer for a mid-size CRO located in Burlington, MA. As the Process Engineer, you 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. Other responsibilities include:

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 procedures and guidelines when handling or disposing of hazardous materials and maintaining overall safety culture
• Provide guidance to co-workers regarding some aspects of their job requirements.

Skills and Requirements:

• Education: Bachelors of Science degree in scientific, Engineering, or related field required.
• Relevant Work Experience: 0-7 years' experience in a cGMP/FDA regulated environment is preferred
• Advanced degree in related field may be considered in lieu of experience
• Meticulous and highly organized.
• 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.
• Hands on experience is preferred

If you are having difficulty in applying or if you have any questions, please contact Taylor Smith at (+1) 570-277-7056 or t.smith@proclinical.com.

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.

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