Description

Lead technical projects, equipment qualification, and compliance initiatives in a GMP manufacturing environment. This role is on-site.

Responsibilities

• Own and lead risk assessments, root cause investigations, and project startup, commissioning, and qualification.
• Manage change control, deviation, and CAPA processes to ensure GMP compliance.
• Oversee contractors, providing guidance and approval for on-site activities.
• Troubleshoot technical issues related to process equipment and systems.
• Lead CAPEX or Continuous Improvement (CI) projects from inception through execution.

Required Skills

• 5+ years of hands-on experience in a GMP manufacturing environment.
• Technical expertise in process equipment and systems.
• Strong knowledge of GMP compliance and safety requirements in manufacturing.
• Proven project leadership experience with the ability to own complex technical initiatives.
• Excellent oral and written communication skills.
• Experience leading risk assessments and root cause investigations.

Preferred Skills

• Master's degree in Engineering or Professional Engineer (P.E.) License.
• 10+ years of related field experience.

Key Skills

Education

Bachelor's or Master's degrees