Senior Process Engineer II

Job Responsibilities:

• Analyze manufacturing data to support continuous process improvements and resolve production issues

• Lead or support FMEAs to evaluate process and product risks as part of validation efforts

• Mentor and train team members across engineering and operations functions

• Ensure successful process validation and comparability by identifying risks, troubleshooting issues, and implementing preventative measures

• Drive investigations using a structured DMAIC approach to determine root cause and assess operational impact

• Collaborate with cross-functional teams to support and enhance production activities

• Evaluate and implement new technologies and automation solutions within GMP manufacturing

• Develop and maintain technical documentation, including protocols and reports for equipment qualification and process validation

• Conduct engineering studies, develop manufacturing recipes, and execute validation testing

• Liaise with vendors to define technical requirements and ensure equipment meets operational needs

• Adapt to evolving production requirements in a dynamic manufacturing environment

• Provide flexible support to meet production schedules and operational priorities

Qualifications:

• Bachelor’s degree or higher in Engineering, Bioengineering, or a related scientific discipline

• 10+ years of experience in a GxP-regulated manufacturing environment (preferably biopharmaceutical or medical device)

• Hands-on experience with sterile injectables: formulation, aseptic filling, inspection, and/or packaging

• Familiarity with data management tools and reliability-centered maintenance (RCM) practices

• Prior experience in a CMO/CDMO environment preferred

• Strong technical writing skills for validation protocols, reports, and risk assessments

• Lean Six Sigma or other technical certifications preferred

• Electro-mechanical aptitude or practical experience is a plus

• Proven ability to work both independently and collaboratively in a fast-paced, regulated setting