Job Details
Posted 15 July, 2026
Job Id: 629161
Senior Process Engineer / System Owner – Bulk Manufacturing (3 roles)
Job Description
Senior Process Engineer / System Owner – Bulk Purification
Position Summary
The Senior Process Engineer / System Owner will provide engineering leadership for bulk purification operations associated with plasma-derived therapeutics manufacturing. The resource will own downstream processing systems throughout design, construction, commissioning, qualification, startup, and handover phases.
The engineer will serve as the technical subject matter expert for chromatography, filtration, and purification systems supporting large-scale biologics manufacturing.
Key Responsibilities
- Serve as System Owner for bulk processing equipment and purification systems.
- Provide technical leadership during design, construction, startup, and CQV phases.
- Review and approve engineering deliverables and vendor documentation.
- Lead system readiness activities and support qualification efforts.
- Maintain alignment between process requirements and project deliverables.
- Support technical troubleshooting and issue resolution.
Areas of Ownership
- Anion Exchange Chromatography
- Immunoaffinity Chromatography
- Simulated Moving Bed (SMB) Chromatography
- Chromatography column handling and packing
- Ultrafiltration/Diafiltration (UF/DF)
- Virus Nanofiltration
- Bulk product transfer and hold systems
Required Qualifications
- BS in Chemical Engineering, Biochemical Engineering, Biotechnology, or related field.
- 10+ years of biologics, plasma fractionation, or downstream processing experience.
- Strong expertise in:
- Chromatography operations
- UF/DF systems
- Virus filtration technologies
- Downstream process equipment
- Experience supporting CQV and startup activities.
- Experience serving as System Owner, Process Lead, MSAT Engineer, or Manufacturing Engineer.
Preferred Qualifications
- Plasma-derived therapeutics manufacturing experience.
- Large-scale purification process expertise.
- Siemens automation exposure.
- Experience supporting greenfield or brownfield capital projects.
Equal Opportunity Employer
We are proud to be an equal opportunity employer. We welcome and encourage applications from all qualified candidates regardless of race, sex, gender identity or expression, disability, age, religion or belief, sexual orientation, or any other characteristic protected by applicable laws and regulations. It is our policy not to discriminate against any applicant or employee, and we are committed to fostering a diverse, inclusive, and respectful work environment across all locations in which we operate. We believe that diversity, equity, and inclusion are fundamental to our mission and enhance our ability to serve clients globally. If you have a disability or require any reasonable accommodations during the application or interview process, please inform your recruiter or contact us directly so that we can explore the appropriate arrangements.
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