Associate Specialist, Engineering
Merck
4 hours ago
On-site
West Point, PA
Operations
Associate Specialist (Biologics Pilot Plant (BPP) Process Engineering Tech Transfer Team)
Responsibilities:
- Prepare and support execution of pilot-scale campaigns for GMP manufacture of bulk vaccine and biologics clinical supplies (upstream and/or downstream unit operations).
- Perform unit operations such as cell culture, virus production, microbial fermentation, tangential flow filtration (TFF), dead-end filtration, homogenization, and chromatography.
- Operate equipment, including cleaning and sanitization.
- Prepare critical documentation such as standard operating procedures (SOPs).
- Participate in equipment start-up activities.
- Maintain training compliance on GMP and safety initiatives.
- Stay informed on industry trends and advancements in vaccine technology to support continuous improvement.
- Support equipment readiness activities including qualification and preparation.
Education:
- Bachelor’s degree in Chemical Engineering, Biological Sciences, or related field.
Required experience/skills:
- Works well in a team environment.
- Able to prioritize work with organizational skills.
- Principled verbal and written communication.
Preferred experience/skills:
- GMP manufacturing of biologicals or vaccines and/or process development activities.
- Knowledge of current GMP regulations.
Additional required/role-relevant capabilities (from required skills):
- Cell culture/cell physiology, mammalian cell culture, chromatography, tangential flow filtration (TFF)
- Equipment qualification, GMP compliance and GMP validation, regulatory compliance
- Process engineering, process optimization/scale-up, process control
- Manufacturing quality control, manufacturing scale-up
- Lean manufacturing, driving continuous improvement, estimation and planning
Work expectations:
- Some overtime required, including weekends and occasional second/third shift work.
Application instructions:
- Apply through https://jobs.merck.com/us/en (or via the Workday Jobs Hub if a current employee). Application deadline is stated on the posting.
Requisition ID: R393603
Responsibilities:
- Prepare and support execution of pilot-scale campaigns for GMP manufacture of bulk vaccine and biologics clinical supplies (upstream and/or downstream unit operations).
- Perform unit operations such as cell culture, virus production, microbial fermentation, tangential flow filtration (TFF), dead-end filtration, homogenization, and chromatography.
- Operate equipment, including cleaning and sanitization.
- Prepare critical documentation such as standard operating procedures (SOPs).
- Participate in equipment start-up activities.
- Maintain training compliance on GMP and safety initiatives.
- Stay informed on industry trends and advancements in vaccine technology to support continuous improvement.
- Support equipment readiness activities including qualification and preparation.
Education:
- Bachelor’s degree in Chemical Engineering, Biological Sciences, or related field.
Required experience/skills:
- Works well in a team environment.
- Able to prioritize work with organizational skills.
- Principled verbal and written communication.
Preferred experience/skills:
- GMP manufacturing of biologicals or vaccines and/or process development activities.
- Knowledge of current GMP regulations.
Additional required/role-relevant capabilities (from required skills):
- Cell culture/cell physiology, mammalian cell culture, chromatography, tangential flow filtration (TFF)
- Equipment qualification, GMP compliance and GMP validation, regulatory compliance
- Process engineering, process optimization/scale-up, process control
- Manufacturing quality control, manufacturing scale-up
- Lean manufacturing, driving continuous improvement, estimation and planning
Work expectations:
- Some overtime required, including weekends and occasional second/third shift work.
Application instructions:
- Apply through https://jobs.merck.com/us/en (or via the Workday Jobs Hub if a current employee). Application deadline is stated on the posting.
Requisition ID: R393603