C&Q Lead

i-Pharm GxP; Alabama; On-site; USD 96,000 - 152,000; Part time

Benefits offered by this job

Competitive hourly rate

Job summary

i-Pharm GxP in Alabama seeks a Commissioning & Qualification (C&Q) Lead for a 12-month, fully on-site contract. You will manage the C&Q program across design through system handover, using ASTM E2500 and Kneat for electronic validation.

Responsibilities include scope, schedule, budget oversight; leading a C&Q team; planning FATs, test cases, field execution; ensuring GMPs and regulatory compliance; training teams on C&Q processes and Kneat; reporting progress to leadership.

Qualifications

• 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.

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.

Skills

Leadership

Communication

Project management

GxP knowledge

Education

BS in Engineering or equivalent experience

Tools

Kneat

Job description

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.