Process Validation Scientist/Engineer
- North America, East Coast
- Contract
- Commissioning, Qualification and Validation
Our client, a global pharmaceutical manufacturing organization are looking for a talented Process Validation Scientist/Engineer to join their expanding team. With continued organizational growth and considerable investment across their portfolio and capital programs this is an extremely exciting opportunity to contribute towards their brand-new manufacturing facility on the East Coast of the United States.
Responsibilities:
- Develop and execute process validation strategies, including:
- Mixing validation
- Prefiltration hold studies
- Process performance qualification (PPQ) runs
- At-scale process validation studies
- Partner with Validation (CQV) to support process qualification execution and assessments, including:
- Worst-case soiling for cleaning validation
- Microbial hold studies
- Mixing validation assessments
- Lead sampling plan development for Process Validation Reports (PVRs) and investigations.
- Train manufacturing staff on process validation execution as needed.
- Serve as a technical SME, supporting:
- Master plans and process risk assessments
- Viral segregation risk assessments
- Contamination control strategy development
- Extractables and leachables assessments
- Regulatory documentation and site procedures
Skills required:
- Manufacturing background: Strong understanding of both upstream (cell culture) and downstream (purification) processes.
- This role typically involves someone who has learned the process and transitioned into validation.
- Experience authoring protocols and performing Process Validation for both upstream and downstream operations.
- Cross-functional work experience; client-facing skills would be a plus.
- Will be working with both the client and internal teams.
- CDMO experience (Resilience would be a great starting point).
- Experience authoring filing sections for programs, in conjunction with protocols and reports.
- Process Validation:
- Managing sampling plans with heavy Process Validation responsibilities.
- Must have prior experience developing a system to track sample batches internally and externally.
- Ability to pull and analyze data efficiently.
Interested in this role? Apply today!
#LI-NR1
I have always received a highly professional & personable service from the team at QCS Staffing. They listen carefully to the specific requirements of available roles and work tirelessly to supply a pool of potential candidates and make the hiring and contract renewal process an easy activity to manage.
Global Pharmaceutical firm
We have worked together with QCS Staffing for seven years now and have always received a professional service. QCS Staffing's speciality certainly lies within their technical sourcing abilities and they have met our demanding requirements time and time again. Coupled with this are the integrity of QCS Staffing's people and their ability to deliver.
Global Pharmaceutical firm
Once again can I via you recognise the superb support I was given before, during and after this short contract. The support, was as usual professional and every friendly.
QA Specialist
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