Process Engineering Advisor – Lyophilization & Filling

Responsibilities:
- Lead the design, selection, and commissioning of lyophilization (freeze-drying) systems and filling equipment for global vaccine production.
- Develop and optimize lyophilization cycles to ensure product stability, quality, and manufacturing efficiency.
- Provide technical oversight for operation and maintenance of freeze dryers; troubleshoot complex mechanical and process issues at global sites.
- Ensure engineering activities and documentation comply with GMPs and internal quality standards.
- Support regulatory filings and inspections with technical documentation for sterile manufacturing processes.
- Collaborate with R&D, Quality Assurance, and Site Operations to transition new products into commercial manufacturing globally.

Minimum Qualifications:
- 7–10 years of process engineering experience in pharmaceutical, biotechnology, or animal health.
- Bachelor’s or Master’s degree in Chemical Engineering, Mechanical Engineering, Bioengineering, or related field.
- Proven experience designing, qualifying, and operating industrial-scale lyophilizers.
- Deep understanding of GMP requirements for sterile manufacturing.
- Strong technical writing and verbal communication skills.

Preferred Qualifications:
- Hands-on aseptic filling experience (isolator technology, vial handling systems).
- Familiarity with USDA-CVB regulations and EMA/EU GMP standards.
- Experience with PLC/SCADA and data historians (e.g., AVEVA PI) for lyophilization monitoring.

Additional:
- Travel: 0–30% domestic/international.
- Location: Indianapolis, IN (Global Headquarters).

Benefits:
- Multiple relocation packages; two weeklong shutdowns (mid-summer and year-end, in addition to PTO); 8-week parental leave; 9 Employee Resource Groups; annual bonus offering; flexible work arrangements; up to 6% 401(k) matching.

Application instructions:
- If you think you may be a fit but don’t meet every requirement, you are encouraged to apply.