Process Engineer
- Remote
- Contract
- Life Sciences
This is a fantastic opportunity for a Process Engineer (Lyophilization) to join our major, global pharmaceutical client on their latest new-build project. This is a large-scale greenfield capital project and investing more than $1bn.
Responsibilities:
- Provide technical input into the selection, layout, and integration of lyophilizers within an ISO8 classified sterile environment.
- Review and influence URSs, equipment specifications, and vendor documentation to ensure operational readiness and compliance.
- Participate in 30/60/90% design reviews, ensuring GMP, Annex 1, and containment requirements are met.
- Advise on containment strategy, isolator interface, and cleanroom interaction.
- Collaborate closely with process engineering, validation, and safety teams during FAT/SAT and startup.
- Represent user needs and engage with external vendors and engineering partners.
- Bachelor’s or Master’s degree in Chemical Engineering, Pharmaceutical Engineering, or a related discipline (e.g., Biochemical or Process Engineering)
- Requires extensive experience with lyophilization systems in GMP pharmaceutical environments.
- Strong understanding of aseptic containment, isolators, and cytotoxic fill-finish practices.
- Prior involvement in equipment design, specification, FAT/SAT, and cleanroom layout preferred.
- Ability to work independently, provide technical leadership, and make decisions in a cross-functional project team.
#LI-AC2
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
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
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
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Anna
I manage this role.