Sterile Process Engineer & Automation Specialist

MSD

Durham, Rahway (NC, NJ)

On-site

GBP 65,000 - 102,000

Full time

2 days ago

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Job summary

MSD in the United States seeks a Specialist Engineer to support commercial drug product manufacturing across sterile filling, lyophilization, and formulation operations. The role begins at the Durham site with rotation to Rahway, NJ, focusing on technical troubleshooting, validations, and process improvements.

The ideal candidate will have a chemical/biochemical engineering or related background, strong GMP knowledge, and proven collaboration skills.

Qualifications

B.S. Degree in Chemical/Bio-Chemical Engineering or Chemistry/Biological Sciences or related disciplines. with a minimum of 2 years of relevant experience.
Familiarity with United States and European Union GMP and safety compliance regulations.
Strong problem-solving skills and ability to work independently.
Strong organizational skills with the ability to manage multiple priorities and deadlines.
Ability to collaborate effectively with cross-functional teams and stakeholders.
Excellent verbal and written communication skills.

Responsibilities

Serve as technical SME for formulation, process development, and scale-up activities.
Support manufacturing by authoring quality investigations, change controls, SOPs, and technical protocols required to support clinical drug product operations.
Contribute to the commissioning, qualification, and regulatory certification of the FLEx Sterile GMP Clinical Manufacturing facility.
Collaborate with formulation scientists, engineers, quality representatives, and other team members to ensure quality of clinical supplies and GMP compliance.
Work with aseptic drug product formulation, filling, and lyophilization equipment across the manufacturing cycle.
Manage project assignments and aid in facility and process equipment innovation.
Perform manual and/or automated operations, maintenance, troubleshooting and support.