More jobs:
C&Q Lead
Job in
Auburn, Lee County, Alabama, 36831, USA
Listed on 2026-09-30
Listing for:
i-Pharm GxP
Full Time
position Listed on 2026-09-30
Job specializations:
-
Engineering
Quality Engineering
Job Description & How to Apply Below
Job Title: Commissioning & Qualification (C&Q) Lead
Location: Fully on-site - Alabama
Initial 12-month contract, with potential for extension based on performance
Competitive W2 hourly rate plus reimbursable expenses
Role
Summary:
The C&Q Lead is responsible for overall management of Commissioning & Qualification (C&Q) delivery, ensuring scope, schedule, budget, and quality standards are met. This role leads an integrated C&Q program throughout the project lifecycle from design through system handover using an ASTM E2500 Verification methodology and electronic validation tools such as Kneat.
Key Responsibilities:
- Manage the C&Q program, including scope, schedule, budget, and team performance.
- Provide technical oversight and guidance to C&Q team members.
- Plan and manage FATs, test case development, and field execution logistics.
- Collaborate with project leadership, construction, automation, QA, and end-user teams to align on project scope and delivery strategy.
- Ensure compliance with GMPs, regulatory requirements, and project safety procedures.
- Train project teams and service providers on C&Q processes, ASTM E2500 Verification, and Kneat electronic validation systems.
- Source and manage test equipment and craft support for field testing.
- Report progress and metrics to project leadership.
- Escalate unresolved issues promptly to maintain project momentum.
Requirements:
- BS in Engineering or equivalent experience.
- 15+ years of C&Q experience in major pharmaceutical project delivery.
- Experience managing Brownfield or Greenfield facility projects through full lifecycle.
- Strong leadership, team management, and communication skills.
- Knowledge of GMPs, regulatory requirements, commissioning, qualification, and ASTM E2500 Verification.
- Hands-on experience with Kneat electronic C&Q/validation system.
Preferred
Skills:
- Demonstrated ability to influence cross-functional teams and facilitate issue resolution.
- Experience implementing integrated C&Q programs in pharmaceutical projects.
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