Sr Project Engineer
Novartis
2 days ago
On-site
Indianapolis, IN
Operations
Major accountabilities:
- Support internal and external audits.
- Prepare project procurement plan; perform project tendering and procurement.
- Lead design, installation, qualification, and lifecycle support of Isotopes API manufacturing equipment.
- Serve as subject matter expert for new equipment supporting the API expansion capital project.
- Own equipment change management to maintain validated state and Good Manufacturing Practice (GMP) compliance.
- Investigate equipment and process deviations; perform root cause analysis and implement corrective and preventive actions.
- Support regulatory inspections and internal audits as engineering subject matter expert.
Essential requirements:
- Bachelor’s degree in Chemical, Electrical, or Mechanical Engineering.
- 5+ years of relevant pharmaceutical industry experience, or 8+ years in lieu of a degree.
- Extensive experience supporting API and/or finish drug product manufacturing.
- Strong expertise with Hot cells / Isolator Containment systems.
- In-depth knowledge of FDA regulations and GMP requirements.
- Experience leading equipment qualification, validation strategies, and change management.
- Strong technical writing skills for regulated engineering documentation.
- Ability to lead cross-functional teams and manage complex capital initiatives.
- Excellent communication, organizational, and problem-solving skills.
Benefits/compensation (as stated):
- Performance-based cash incentive; eligibility for annual equity awards (depending on level).
- Comprehensive benefits package (US-based eligible employees) including health, life and disability; 401(k) with company contribution and match; other benefits; time off (vacation, personal days, holidays, other leaves).
Application instructions (accessibility-related, if needed):
- For reasonable accommodations, email [email protected] or call +1(877)395-2339; include the job requisition number in the message.
- Support internal and external audits.
- Prepare project procurement plan; perform project tendering and procurement.
- Lead design, installation, qualification, and lifecycle support of Isotopes API manufacturing equipment.
- Serve as subject matter expert for new equipment supporting the API expansion capital project.
- Own equipment change management to maintain validated state and Good Manufacturing Practice (GMP) compliance.
- Investigate equipment and process deviations; perform root cause analysis and implement corrective and preventive actions.
- Support regulatory inspections and internal audits as engineering subject matter expert.
Essential requirements:
- Bachelor’s degree in Chemical, Electrical, or Mechanical Engineering.
- 5+ years of relevant pharmaceutical industry experience, or 8+ years in lieu of a degree.
- Extensive experience supporting API and/or finish drug product manufacturing.
- Strong expertise with Hot cells / Isolator Containment systems.
- In-depth knowledge of FDA regulations and GMP requirements.
- Experience leading equipment qualification, validation strategies, and change management.
- Strong technical writing skills for regulated engineering documentation.
- Ability to lead cross-functional teams and manage complex capital initiatives.
- Excellent communication, organizational, and problem-solving skills.
Benefits/compensation (as stated):
- Performance-based cash incentive; eligibility for annual equity awards (depending on level).
- Comprehensive benefits package (US-based eligible employees) including health, life and disability; 401(k) with company contribution and match; other benefits; time off (vacation, personal days, holidays, other leaves).
Application instructions (accessibility-related, if needed):
- For reasonable accommodations, email [email protected] or call +1(877)395-2339; include the job requisition number in the message.