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About Company:
JC Automation Corp. (JCA) was founded in 1997 with the mission of filling a gap between technology and regulatory requirements in the life science manufacturing industry. The company offers highly capable resources at an affordable cost to build solutions and execute projects in: Automation, Control Systems Integration, Information Technology, System Integration and Regulatory Compliance.
JCA is a HUBZone Certified Small Business Firm, NMSDC Certified Minority Business Enterprise, and Certified Critical Industry Supplier. It’s mission is to add value by delivering quality services & solutions on time all the time by transforming processes & technology into business advantages.
ABOUT THE ROLE
We are looking for a hands-on and detail-driven Commissioning & Qualification (C&Q) Support professional to join our team in a dynamic, fast-paced pharmaceutical manufacturing environment. In this role, you will play a key part in ensuring that equipment and systems are properly installed, tested, and qualified before being released to production operations.
You will work closely with engineering, automation, quality, and vendor teams throughout the execution of commissioning and qualification activities, contributing directly to the successful startup of critical manufacturing systems. This is a field-intensive, documentation-focused role that requires strong attention to detail, a collaborative mindset, and a solid understanding of GMP principles and validation lifecycle requirements.
RESPONSIBILITIES
- Support Commissioning & Qualification (C&Q) activities for equipment and systems installed within GMP-regulated pharmaceutical facilities.
- Assist in the execution of commissioning and qualification protocols (IQ, OQ, PQ) in coordination with validation and engineering teams.
- Support preparation and review of C&Q documentation, including protocols, test scripts, and summary reports.
- Coordinate field activities related to equipment startup, testing, and system verification.
- Interface with engineering, automation, vendors, and quality/validation teams during all execution phases.
- Ensure all C&Q activities are performed in full compliance with GMP requirements, company SOPs, and applicable regulatory expectations.
- Support identification, documentation, and resolution of deviations and discrepancies encountered during testing and qualification.
- Assist with punch list tracking and closure activities prior to system release.
- Support system readiness for hand-off to operations, ensuring all acceptance criteria have been met.
- Maintain accurate, organized, and audit-ready C&Q documentation throughout the project lifecycle.
REQUIREMENTS & QUALIFICATIONS
Education
- Bachelor's degree in Engineering (Mechanical, Chemical, Electrical, or a related technical discipline).
Experience
- Experience supporting Commissioning & Qualification (C&Q), validation, or startup activities in pharmaceutical or regulated manufacturing environments.
- Hands-on experience executing or supporting IQ/OQ/PQ protocols for manufacturing equipment or utility systems.
- Direct experience working in GMP-regulated facilities.
- Experience coordinating with cross-functional teams including Engineering, Automation, and Quality/Validation.
- Exposure to equipment installation, startup, or system turnover activities.
Preferred
- Familiarity with commissioning and qualification documentation practices in a pharmaceutical or biotech setting.
- Experience supporting deviation management and CAPA processes during qualification phases.
- Knowledge of regulatory frameworks such as FDA 21 CFR Part 11, GAMP 5, or EU GMP Annex 11.
SKILLS
Technical Skills
- Working knowledge of GMP, validation lifecycle, and pharmaceutical regulatory expectations
- Hands-on execution of IQ, OQ, and PQ protocols for manufacturing and utility systems
- C&Q documentation development, review, and audit readiness
- Deviation identification, documentation, and resolution support
- Punch list management and system turnover coordination
- Familiarity with engineering drawings, P&IDs, and equipment manuals
- Microsoft Office 365 (Word, Excel, Outlook, Teams)
Soft Skills
- Strong attention to detail and commitment to documentation accuracy
- Clear and proactive communication across multidisciplinary teams
- Ability to work independently in a structured field environment
- Organized, methodical, and adaptable under project timelines
- Team-oriented with a collaborative approach to problem solving
- Willingness to work on-site during testing, startup, and qualification phases
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