Senior Technical Transfer Engineer – Sterile Injectables (MS&T)

Planet Pharma; Bloomington (IN); On-site; USD 88,000 - 100,000; Full time

Benefits offered by this job

Annual Bonus

Sign-on bonus

Job summary

A leading pharmaceutical company located in Bloomington, IN, is seeking a Senior Technical Transfer Engineer to handle the technical onboarding of new sterile injectable drug products. This essential role leads cross-functional development and validation activities, assuring compliance and efficiency in product manufacturing processes. Candidates should have at least 7 years of experience in pharmaceutical manufacturing and a Bachelor’s degree in a relevant field. Strong technical documentation skills and expertise in aseptic processing are required for this onsite position.

Qualifications

• 7+ years of experience in pharmaceutical manufacturing.
• 3+ years in Technical Transfer, MSAT, Process Development, or Validation.
• Experience in cGMP environments.

Responsibilities

• Lead technical onboarding and process development for new drug product introductions.
• Own and author technical transfer documentation.
• Support handoff to commercial manufacturing.

Skills

Technical onboarding

Process development

Root cause analysis

Technical documentation skills

Education

Bachelor’s degree in Science, Engineering, or related field

Tools

Microsoft Word

Excel

Outlook

JDE

BPLM

Minitab

TrackWise

Job description

Senior Technical Transfer Engineer – Sterile Injectables (MS&T)

Location: Bloomington, IN (Onsite)

Employment Type: Full-time, Permanent

Base Pay Range: $88,000.00/yr - $100,000.00/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

Required Qualifications

• 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, TrackWise, or similar

Strong Expertise In

• Aseptic processing and sterile filtration
• Process validation and PPQ
• Mixing systems, scales, and formulation technologies
• Homogeneity testing, control charting, and trend analysis

Work Environment & 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

Why Join

• 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