Senior Process Engineer
Senior Process Engineer
What We Value
- Empowering and supporting one another
- Relentless commitment to client success
- The courage to do what's right
- An inclusive environment where everyone feels respected, engaged, and challenged
- Continuous learning and shared expertise
The Role
We're seeking a Senior Process Engineer to join our Manufacturing Science and Technology (MSAT) team, supporting GMP biologics drug substance manufacturing within a CDMO setting. This role centers on technology transfer, process scale-up, manufacturing support, and hands-on technical troubleshooting. The right candidate brings solid upstream and/or downstream biologics experience, deep GMP knowledge, and polished client-facing communication skills.
What You'll Do
- Act as a technical Subject Matter Expert (SME) for GMP biologics drug substance manufacturing
- Lead technology transfers from process development and external clients into GMP manufacturing
- Support process development, scale-up, optimization, and manufacturing process design
- Author, review, and maintain Master Batch Records (MBRs) and related manufacturing documentation
- Provide technical direction for upstream and/or downstream biologics operations
- Participate in deviation investigations, impact assessments, CAPAs, change controls, and other QMS activities
- Assess process parameters, CQAs, CPPs, and QTPPs
- Troubleshoot manufacturing issues and drive process improvements
- Partner with Manufacturing, Quality, Engineering, and external clients to ensure smooth process execution
- Contribute to process characterization, validation, and manufacturing readiness efforts
What You'll Need
- Bachelor's degree in Chemical Engineering, Biochemical Engineering, Biotechnology, or a related field
- MSAT, process engineering, or process development experience in biologics manufacturing
- Demonstrated technology transfer experience supporting GMP biologics drug substance manufacturing
- Hands-on knowledge of upstream and/or downstream bioprocessing
- Experience with scale-up, process design, and manufacturing optimization
- Track record developing or reviewing MBRs and GMP documentation
- Working knowledge of QTPPs, CQAs, and CPPs
- Familiarity with GMP quality systems (deviations, CAPAs, change controls, impact assessments)
- Excellent communication and client-facing skills; comfortable working independently with minimal supervision
Nice to Have
- MSAT experience in a CDMO environment
- Exposure to both upstream and downstream operations
- Hands-on experience with bioreactors, cell culture, chromatography, filtration, or UF/DF
- Involvement in process characterization, PPQ, and process validation
- Direct experience leading client-facing technology transfers
Compensation & Benefits
A competitive salary range for US locations applies to this position; the final offer depends on professional background, training, work experience, location, business needs, and market conditions.
We are an equal opportunity employer.
Benefits include: medical, dental & vision coverage; company-paid life, short-term, and long-term disability insurance; FSA, DCARE, and commuter benefits; supplemental life, hospital, critical illness, and legal insurance; HSA; 401(k) with employer matching; paid time off with rollover option plus holidays; as-needed sick time; tuition reimbursement; parental leave and bereavement pay; employee recognition and referral programs; and regular team social events.
FAQs
Congratulations, we understand that taking the time to apply is a big step. When you apply, your details go directly to the consultant who is sourcing talent. Due to demand, we may not get back to all applicants that have applied. However, we always keep your CV and details on file so when we see similar roles or see skillsets that drive growth in organisations, we will always reach out to discuss opportunities.
Yes. Even if this role isn’t a perfect match, applying allows us to understand your expertise and ambitions, ensuring you're on our radar for the right opportunity when it arises.
We also work in several ways, firstly we advertise our roles available on our site, however, often due to confidentiality we may not post all. We also work with clients who are more focused on skills and understanding what is required to future-proof their business.
That's why we recommend registering your CV so you can be considered for roles that have yet to be created.
Yes, we help with CV and interview preparation. From customised support on how to optimise your CV to interview preparation and compensation negotiations, we advocate for you throughout your next career move.