MSAT Engineer

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The MSAT Engineer will support the Existing Commercial Product Improvement Project as a Subject Matter Expert (SME), with responsibilities spanning Process Validation, Technology Transfer (TT), Manufacturing Science, and process/technology development activities. This role will also involve significant support for purification and fractionation processes, including filtration technologies and upstream operations.

• Lead or support deviations, investigations, and CAPA activities related to drug product manufacturing.
• Serve as process owner for designated unit operations or systems, including purification, upstream processing, and plasma-derived product fractionation steps.
• Support and provide SME input for filtration operations—particularly filter press systems—and related unit operations involving buffers, vessels, and UF/DF or TFF skids.
• Perform data analysis to support process understanding, validation, technology transfer, and DOE (Design of Experiments) studies.
• Author, review, and manage technical documentation including SOPs, batch records, validation protocols, and technical reports.
• Conduct non‑GMP laboratory development work, including sample testing, data analysis, and method evaluation to support process characterization and optimization prior to GMP execution.
• Collaborate as a liaison between development labs, manufacturing operations, QA, Regulatory Affairs, Engineering, and other cross‑functional teams.
• Prepare technical slide decks, data summaries, and presentation materials for internal reviews and external regulatory interactions, including meetings with the FDA.
• Contribute to the preparation and review of regulatory submissions (e.g., Module 3, 3.2.P.3).
• Participate in technology transfer activities to ensure smooth transition from development to GMP operations.

• Strong knowledge of process validation principles and the PV lifecycle (PPQ, continued process verification).
• Experience supporting or leading technology transfer projects in a GMP environment.
• Demonstrated proficiency in deviation and investigation writing, CAPA, and change control management.
• Hands‑on experience authoring SOPs, protocols, reports, and other technical documentation.
• Ability to analyze and interpret manufacturing, analytical, and development data.
• Experience with purification processes, upstream operations, plasma fractionation, filtration (including filter press systems), buffer preparation, and UF/DF or TFF skids preferred.
• Familiarity with regulatory expectations for submissions and dossier content.
• Strong communication, collaboration, and presentation skills, including ability to prepare and present data to regulatory agencies.
• Experience working in biologics, sterile injectables, or plasma‑derived product manufacturing is highly preferred.
• Ability to work in both development (non‑GMP) and GMP environments as processes advance through the lifecycle.

• Competitive Compensation:
  Attractive salary and comprehensive benefits package for full‑time and part‑time employees, including health, dental, vision, and life insurance, a 401(k) plan with employer match, a generous paid time‑off policy, and additional perks. Compensation is commensurate with professional experience.
• Career Development:
  Opportunities for professional growth and advancement within a supportive and innovative environment.
• Work‑Life Balance:
  Flexible work arrangements and a commitment to maintaining a healthy work‑life balance.

Clark & Enersen is proud to be an Equal Opportunity Employer, committed to employee diversity.

Mid‑Senior level

Full‑time

Engineering and Information Technology

Architecture and Planning