Pharma Process Engineer / Technical SME

Job Title: Pharma Process Engineer / Technical SME (Small Molecule) Location: Morristown, NJ (Hybrid – 3 days onsite/week) Duration: 2 Years Contract Visa: Open to All

Job Description:

We are looking for a highly experienced Pharma Process Engineer / Technical SME to support external manufacturing operations. This is a long-term contract role focused on providing technical oversight and support for products manufactured at third-party Contract Manufacturing Organizations (CMOs) .

The ideal candidate will have strong small molecule experience and a proven track record in CMO oversight, process validation, and technical operations within a cGMP-regulated environment.

Key Responsibilities:

Act as technical SME for externally manufactured products

Provide oversight and support to CMOs and third-party manufacturing sites

Conduct batch monitoring and frequent site visits

Support process validation, troubleshooting, and investigations

Review and approve technical documents and protocols

Analyze data trends and provide actionable insights

Collaborate with cross-functional teams including QA, manufacturing, and engineering

Ensure compliance with cGMP and regulatory requirements

Required Qualifications:

8–10 years of experience in Pharma Operations / Technical Operations

Strong experience with small molecule manufacturing (MANDATORY)

Proven experience supporting CMOs / external manufacturing

Expertise in process validation, equipment troubleshooting, and investigations

Strong technical writing and documentation skills

Proficiency in MS Word, Excel, and PowerPoint

Experience in data analysis and trend evaluation

Bachelor’s degree required

Work Schedule:

Hybrid: 3 days onsite/week (One day must be Monday or Friday)

Frequent travel to CMO sites required

Additional Notes:

Client details will be shared after candidate qualification

Two recent work references required upon submission

AI-generated resumes will not be considered

Apply Now

If you have strong small molecule and CMO oversight experience and are looking for a long-term opportunity, apply today.