Downstream Tech Transfer Engineer - Biologics Manufacturing

Catalent Pharma Solutions; Alabama; On-site; USD 90,000 - 140,000; Full time

Benefits offered by this job

152 hours PTO + 8 holidays

401K match

Medical, dental and vision benefits

Tuition Reimbursement

Job summary

Catalent Pharma Solutions in Madison, WI, is seeking a Process Engineer for MS&T downstream tech transfer to enable transfer of biologic processes from development to GMP manufacturing. The role requires deep experience in mammalian cell culture, process transfer, and technical documentation, with leadership responsibilities and cross‑functional collaboration.

You will support facility fit, equipment alignment, data-driven improvements, and risk assessments across cGMP programs, including

Qualifications

• Must have an Associate’s degree in STEM with 6+ years of related experience.
• Bachelor’s and/or Master’s with at least 3+ years of related experience preferred.
• Experience in mRNA product development/manufacturing and protein therapeutics MFG.
• Experience authoring, revising, and reviewing technical documentation with statistical data analysis.

Responsibilities

• Provide technical support for facility fit, equipment alignment, and technology transfer of biologic processes.
• Evaluate process and equipment improvements while supporting tech transfer.
• Execute technical work plans, data generation, and entry in collaboration with supervisors.
• Perform engineering and process calculations to support development, tech transfer, and GMP manufacturing.
• Draft and review development reports, tech transfer reports, batch records, and specs.
• Lead or support risk assessments, deviations, CAPAs, with root cause analysis.

Skills

Mammalian cell culture

Upstream/downstream tech transfer

Technical documentation

CAPA and deviation handling

Leadership/mentoring

Process calculations

cGMP manufacturing

Project management

Statistical data analysis

Education

Associate’s degree in STEM

Bachelor’s or Master’s degree (preferred)

Tools

Single-use systems

GMP equipment

Job description

Catalent Pharma Solutions in Madison, WI, is seeking a Process Engineer for MS&T downstream tech transfer to enable transfer of biologic processes from development to GMP manufacturing. The role requires deep experience in mammalian cell culture, process transfer, and technical documentation, with leadership responsibilities and cross‑functional collaboration.

You will support facility fit, equipment alignment, data-driven improvements, and risk assessments across cGMP programs, including