Biological Project Engineer

Description

• Due to client requirements this role is only open to W2 only*

Job Summary: Biological Project Engineer

Position Overview: The Staff Product Transfer Project Engineer - Bioprocessing provides technical leadership for

complex biologics manufacturing technology transfer programs between Contract Manufacturing Organization

(CMOs) and internal manufacturing sites. The role supports sterile injectable biologic drug products by leading

engineering activities and providing technical support across process development, transfer, qualification,

validation, regulatory support, and commercial manufacturing readiness.

Key Responsibilities:

? Lead end-to-end bioprocess technology transfer activities, including process adaptation, scale-up,

equipment qualification, validation, and commercial readiness.

? Serve as the primary engineering liaison between external manufacturing partners and internal Technical

Operations, Regulatory Affairs, Quality, Manufacturing, Supply Chain, and Validation teams.

? Collaborate with internal cross-functional teams and external partners to lead technical discussions,

resolve issues, communicate project status, risks, and recommendations to leadership, and ensure

successful execution of transfer activities.

? Conduct engineering gap assessments and technical risk evaluations using structured methodologies such

as FMEA.

? Support regulatory submissions, Biologics License Application (BLA) supplements, inspection readiness,

and technical justifications related to manufacturing transfers.

? Support analytical test method transfers activities, IQ, OQ, PQ, GMP, non-GMP, engineering, and PPQ

campaign execution, including review of protocols, reports, batch records, and technical documentation

to ensure compliance with regulatory expectations, quality standards, and project timelines.

? Manage engineering change strategies, ECOs, and documentation release activities through change

control systems.

? Perform other duties as assigned to support Product Transfer and Technical Operations.

Required Qualifications:

? Preferred M.S. or Ph.D. in Chemistry, Biochemistry, Pharmaceutical Sciences, Biotechnology, or

Engineering; B.S. considered with significant relevant experience.

? Minimum 4 years of engineering experience in biotechnology, biologics, pharmaceutical, or medical

device industries.

? Minimum 4 years supporting technology transfer, manufacturing engineering, process engineering,

validation, or scale-up in FDA-regulated cGMP environments.

? Experience working with Contract Manufacturing Organization (CMOs) and scientific leadership

experience in GMP biologics manufacturing are preferred.

Key Skills and Knowledge:

? Strong understanding of biologics manufacturing, upstream and downstream bioprocessing, sterile

manufacturing, single-use systems, protein formulation, stability, and analytical methods.

? Working knowledge of FDA, EMA, ICH, cGMP requirements, process validation lifecycle, regulatory

submissions, and post-approval manufacturing changes.

? Excellent project management, technical writing, communication, organizational, and stakeholder-

influence skills in highly regulated environments.

Travel: Domestic and international travel up to 25%, depending on project phase.

About Matlen Silver

Experience Matters. Let your experience be driven by our experience. For more than 40 years, Matlen Silver has delivered solutions for complex talent and technology needs to Fortune 500 companies and industry leaders. Led by hard work, honesty, and a trusted team of experts, we can say that Matlen Silver technology has created a solutions experience and legacy of success that is the difference in the way the world works.

Matlen Silver is an Equal Opportunity Employer and considers all applicants for all positions without regard to race, color, religion, gender, national origin, age, sexual orientation, veteran status, the presence of a non-job-related medical condition or disability, or any other legally protected status.

If you are a person with a disability needing assistance with the application or at any point in the hiring process, please contact us at email and/or phone at: [email protected] // 908-393-8600

At The Matlen Silver Group, Inc., W2 employees are eligible for the following benefits:

• Health, vision, and dental insurance (single and family coverage)
• 401(k) plan (employee contributions only)