One of our leading Pharmaceutical client is looking for a Sterile Process Engineer who is responsible for acting as an interface between formulation scientists and manufacturing operations. He/She will focus on the development of sterile drug product processes and container closure systems (e.g., vials, elastomeric stoppers, pre-filled syringes).
Job Title: Sterile Process Engineer
W2 Contract & Onsite role
Location: Foster City , CA
Required Education & Experience:-
- Must have experience in pharmaceutical parenteral formulations and/or drug product sterile process engineering
- Author protocols, reports, execute studies using good laboratory practices (GLP)
- Lab experience
Job Description:-
- Apply fundamental engineering principles to the design, development, scale-up, and validation of processes for sterile drug product unit operations (e.g., refrigerated/frozen storage and handling of bulk solutions, dissolution of APIs, pooling and mixing, sterile filtration, filling, pre-filled syringe processing, lyophilization, and vial capping) for both small molecule and large molecule parenterals
- Execute studies and author reports related to container closure system compatibility and sterile process engineering
- Author and maintain internal specifications for container closure system components (vials, stoppers, seals, pre-filled syringes, plungers, etc…)
- Qualified candidates should be self-motivated and organized, knowledgeable of relevant scientific literature, passionate about scientific inquiry and investigation, proactive in identifying and addressing potential challenges, and collaborative in driving solutions.
If you are a right fit as per the skills requirements and this job excites you then please apply quick!!