Lead C&Q Engineer - Pharma Manufacturing (On-site)

ACE Technologies, LLC; Indianapolis (IN); On-site; USD 110,000 - 165,000; Full time

Job summary

ACE Technologies, LLC is seeking a Senior Commissioning & Qualification Engineer to lead C&Q activities for major pharmaceutical projects on-site in Indiana. The role requires expertise in GMP, validation planning, and cross-functional team leadership.

You will manage IV/OV testing, develop validation strategies, and mentor engineers while ensuring regulatory alignment and project delivery excellence across facilities in Indianapolis or Lebanon, IN.

Qualifications

• Minimum 5 years of experience in commissioning and qualification within pharmaceutical, biotech, chemical, or related industries.
• Bachelor's degree in Engineering, Life Sciences, or related field; advanced degree preferred.
• Demonstrated experience leading large-scale C&Q efforts and cross-functional project teams.
• Familiarity with GMP, FDA, EMA, and ISPE guidelines; strong working knowledge of ASTM E2500 and risk-based verification approaches.
• Proficiency in project and validation management tools (e.g., Kneat, Smartsheet, or equivalent).

Responsibilities

• Lead all C&Q activities across assigned systems, equipment, and facilities.
• Develop project-specific validation approaches consistent with client and ACE requirements.
• Prepare, review, and approve C&Q deliverables, including validation plans and reports.
• Oversee IV/OV testing; ensure protocols are executed accurately and deviations resolved.
• Provide technical guidance and mentorship to C&Q engineers and junior staff.
• Collaborate with vendors, contractors, and client representatives to ensure smooth execution.

Skills

GMP knowledge and regulatory

Cross-functional leadership

Project management

Analytical problem-solving

Effective communication

Team mentorship

Education

Bachelor's degree in Engineering or Life Sciences

Advanced degree preferred

Tools

Kneat

Smartsheet

Job description

ACE Technologies, LLC is seeking a Senior Commissioning & Qualification Engineer to lead C&Q activities for major pharmaceutical projects on-site in Indiana. The role requires expertise in GMP, validation planning, and cross-functional team leadership.

You will manage IV/OV testing, develop validation strategies, and mentor engineers while ensuring regulatory alignment and project delivery excellence across facilities in Indianapolis or Lebanon, IN.