Job Description

My name is Minakshi and I'm working on Process Engineer III role with our pharma client . Please find the Job description below and let us know if you are interested.

Title:- Process Engineer III

Location: St. Louis, MO

Duration: Contract until March 2026 (Possible extension)

Job id:- SNFIJP00009629

JOB DESCRIPTION:

Candidates must be local to the St. Louis, MO area and willing to visit local CMO. (Location is ?5 mins from the airport)

• No other team members are local, manager sits in Framingham, MA

• Free parking onsite, coordinator with CMO

• Role is primarily remote, they will not report onsite daily.

• Possibility for travel to Framingham, MA and reimbursement would be provided

• Possibility of extension.

Must Have:

• Direct (hands-on) lab experience in biologics development would be good experience. Technical supporting role of commercial biologics processes. This would include activities like root cause investigation, process validation, lifecycle manage, and/or process trending. All of this would be done in alignment with GMP practices.

• Process validation & Root cause analysis and/or risk assessment experience

• Bachelor’s degree in engineering or science with 5 years of experience in Process Engineer or related role at Pharm/ Biotech Company

OR

master’s degree in engineering or science with 3 years’ experience in Process Engineer or related role at Pharm/ Biotech Company

• PhD candidates welcome if min of 3 years of experience as mentioned above

Nice to Have

• Prior experience in a technical role supporting a GMP, MSAT or commercial processes,

• Experience with equipment qualification

KEY RESPONSIBILITIES

The successful candidate will work with a group of scientists and engineers responsible for support of commercial mammalian cell culture processes in the external manufacturing MSAT group. This group support commercial operations across a diverse network of manufacturing facilities and external partners. Key responsibilities may differ among employees with same job title and may change over time in accordance with business needs.

• Provide technical support and routine process monitoring for commercial products manufactured at CMOs.

• Provides person-in-plant observations of manufacturing operations at CMOs and communicates observations to the product team.

• Reviews manufacturing processes, deviations, and/or development and production data.

• Reviews manufacturing batch records, protocols, and control strategies.

• Provide technical support and data analysis for investigations and deviation resolution.

• Recommends changes or additional experiments to improve quality, productivity, recovery, and overall efficiency.

• Interacts with colleagues and external partners from various functions, such as Engineering, Manufacturing, and Quality departments

• Oversees and reports on overall manufacturing progress.

BASIC QUALIFICATIONS

• Bachelor’s degree in engineering or science with 5 years of experience

OR

• Master’s degree in engineering or science with 3 years of experience

• Experience in biologics development, bioprocess engineering, technology transfer, and / or commercial manufacturing operations

PREFERRED QUALIFICATIONS

• Experience with Good Manufacturing Practices and supporting a commercial facility

• Experience in cell culture and/or downstream purification (direct lab experience a plus)

• Experience with equipment qualification and process validation

• Familiarity with formal root cause analysis and/or risk assessment

• Experience working with statistical analysis software and investigative data analysis

• Experience with project leadership

• Experience communicating with cross functional teams

• Strong technical writing and communication skills

• Proficient in Microsoft Word, Excel, and PowerPoint

SPECIAL WORKING CONDITIONS

• Ability to gown and gain entry to manufacturing areas

• Ability to travel (up to 20% of time)

MINAKSHI SANGWAN

Recruiting Lead - US Recruitment

O 732-339-3518

E [email protected]

W

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