Commissioning and Qualification Lead
2 weeks ago
Pharmaceutical Commissioning and Qualification Lead Opportunity
Pharmavise Consulting Corp. is seeking a highly experienced Commissioning and Qualification Lead to join our team in Lebanon, Indiana. As a Commissioning and Qualification Lead, you will be responsible for managing the entire Commissioning and Qualification process within Good Manufacturing Practice regulated environments.
Key Responsibilities and Qualifications
- Lead and execute the Commissioning and Qualification process, facilitating alignment sessions and supporting the implementation of new processes.
- Provide clear guidance on using Commissioning and Qualification templates, drafting and updating critical Commissioning and Qualification plans, such as the Project Validation Plan and Test Plan.
- Track and resolve Commissioning and Qualification action items, ensuring accurate documentation and compliance.
- Offer expertise on validation standards, including FDA regulations for medical devices and combination products.
- Oversee document reviews and approvals, monitoring Commissioning and Qualification progress and reporting metrics to the IDM Engineering C&Q Manager.
- Drive continuous improvement through process evaluations, working closely with various project functions to maintain Commissioning and Qualification alignment.
- Create a staffing model to support Commissioning and Qualification activities, manage support staff, and participate in essential project meetings.
- Handle administrative tasks, including access requests for validation platforms and engage in Design Review sessions and Site Acceptance Testing activities.
Requirements and Qualifications
- 10+ years of experience as a Commissioning and Qualifications Lead in a Pharmaceutical setting.
- Bachelor's Degree or Advanced Degrees related to Engineering and Life Sciences.
- Proficiency in validation for equipment and computer systems within GMP-regulated settings, preferably in the pharmaceutical industries.
- In-depth knowledge of external validation standards, including FDA standards for medical devices.
- Exceptional communication skills with the ability to guide team members and influence cross-functional stakeholders informally.
- Demonstrated capability to work independently in a complex network environment, with initiative and problem-solving skills.
- Prior experience with automated equipment validation and managing large, cross-functional projects.
- Strong understanding of how validation is impacted by modifications to equipment or systems.
- Travel Requirements: Ability to travel internationally and domestically to Original Equipment Manufacturers for design reviews, Factory Acceptance Testing, and Site Acceptance Testing, including extended presence for entire review periods.
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