Senior Technical Transfer Engineer – Sterile Injectables; MS&T
Listed on 2026-01-04
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Engineering
Quality Engineering, Validation Engineer
Senior Technical Transfer Engineer – Sterile Injectables (MS&T)
Location: Bloomington, IN (Onsite)
Employment Type: Full-time, Permanent
Base Pay Range: $88,000.00/yr - $/yr
Additional Compensation: Annual Bonus and Sign‑on bonus
We are seeking a Senior Technical Transfer Associate (MS&T) to join a growing technical services team supporting the transfer, development, and validation of sterile injectable drug products into commercial manufacturing.
This is a senior‑level, hands‑on technical role responsible for owning the technical onboarding of new products, leading cross‑functional development and validation activities, and serving as a subject matter expert across manufacturing, quality, and regulatory functions.
This role is 100% onsite and works closely with internal stakeholders and external partners to ensure successful, compliant, and efficient transfer of new drug products into manufacturing.
Key Responsibilities- Lead technical onboarding and process development for new drug product introductions
- Own and author technical transfer documentation, including Technical Transfer Plans, Process Development studies (mixing, filtration, purge studies, etc.), Demonstration and PPQ batch records
- Lead or co‑lead PPQ strategy and protocol development in partnership with validation teams
- Support handoff to commercial manufacturing following validation activities
- Provide day‑to‑day technical support to manufacturing and troubleshoot process issues on the production floor
- Lead process improvement initiatives
- Own and investigate deviations (NCRs), perform root cause analysis, and implement CAPAs
- Own change controls and perform impact assessments
- Own Fill Volume Dosing Qualification (FVOQ) documentation
- Evaluate product readiness for release and ensure regulatory compliance
- Review batch records and mentor junior team members
- Represent the organization as a product/process SME in regulatory, client, and internal audits
- Participate in client meetings and onsite visits to align on technical strategy and issue resolution
- Own and maintain SOPs related to technical processes
- Develop and deliver internal technical training and SME courses
- Mentor and train new hires within the technical services organization
- Bachelor’s degree in Science, Engineering, or related field
- 7+ years of experience in pharmaceutical manufacturing
- 3+ years of experience in Technical Transfer, MSAT, Process Development, or Process Validation
- Experience working in cGMP environments and supporting regulatory inspections
- Strong technical documentation skills
- Proficiency with Microsoft Word, Excel, and Outlook
- Experience with enterprise systems such as JDE, BPLM, Minitab, Track Wise, or similar
- Aseptic processing and sterile filtration
- Process validation and PPQ
- Mixing systems, scales, and formulation technologies
- Homogeneity testing, control charting, and trend analysis
Physical Requirements
- 100% onsite role in a manufacturing environment
- Occasional overtime, including nights or weekends, may be required
- Ability to work in cleanroom environments and qualify for Grade A/B gowning
- Ability to wear required personal protective equipment (PPE)
- Role includes a mix of desk work and time on the manufacturing floor
- Take full technical ownership of high‑impact pharmaceutical projects
- Work cross‑functionally with experts in development, manufacturing, quality, and regulatory affairs
- Play a direct role in bringing critical medicines to patients
- Grow technically and professionally within a collaborative, quality‑driven organization
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