Commissioning and Qualification Program Lead - ASTM E2500
About The Position
We provide Recruitment and Staffing services to many industries and domain through our innovative and customized solutions and passionate commitment to research. Ability to understand the hiring strategies, availability of talent and compensation benchmarking makes us proud hiring partner for various industries. We work as trusted business partners and always strive to deliver the most value and highest return on investment for our clients. We are highly trained business professionals with strong understanding of clients need. We work closely with the leading staffing trade associations, training, and research organizations to ensure we are knowledgeable of the latest industry trends and technologies.
Requirements
- Bachelor’s degree in Engineering or equivalent practical experience.
- 15+ years of experience delivering C&Q efforts for large pharmaceutical programs.
- Proven track record supporting full‑lifecycle delivery of both Greenfield and Brownfield facilities.
- Strong team‑building, leadership, and communication skills.
- Expertise in GMPs, regulatory frameworks, commissioning, qualification, and ASTM E2500 practices.
- Hands‑on proficiency with Kneat or similar electronic C&Q/validation platforms.
Responsibilities
- Provide strategic leadership for all C&Q activities, ensuring scope, timelines, and budgets are consistently met.
- Direct day‑to‑day performance of the C&Q team and offer technical guidance to support successful project delivery.
- Develop and oversee FAT planning, test case creation, and all field execution logistics.
- Partner closely with construction, automation, QA, project management, and end‑user groups to maintain alignment on system requirements and delivery expectations.
- Maintain adherence to GMPs, regulatory standards, internal procedures, and overall project safety practices.
- Lead training sessions for internal teams and external vendors on C&Q methodology, ASTM E2500 processes, and Kneat system usage.
- Coordinate the sourcing, readiness, and deployment of test equipment and field support resources.
- Communicate progress, risks, and performance metrics to project leadership with clarity and consistency.
- Drive timely escalation and resolution of technical issues to keep projects moving efficiently.
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What This Job Offers
Job Type
Full-time
Career Level
Mid Level
Number of Employees
11-50 employees
