C&Q Lead

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.