Job ID: JOB_ID_7427
Job Summary:
We are seeking a highly experienced and strategic Commissioning and Qualification Program Lead to oversee and execute C&Q activities for a multi-year project. This role requires extensive experience in pharmaceutical greenfield site development and a strong understanding of GMPs and regulatory standards. The ideal candidate will provide strategic leadership, manage C&Q teams, and ensure successful project delivery by collaborating effectively with cross-functional teams.
Primary 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.
Qualifications:
- Bachelors 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 teambuilding, 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.
Project Details:
- Location: Virginia (Onsite)
- Employment Type: Contract (Multi-Year Project)
- Interviews: Virtual
- Relocation: Works for candidates willing to relocate.
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Special Requirements
US or Card ONLY – Interviews are virtual. Multiyear project. Relocation works.
Compensation & Location
Salary: $150,000 – $200,000 per year
Location: Virginia, VA
Recruiter / Company – Contact Information
Email: in@smartiplace.net
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