Commissioning & Qualification (C&Q) Lead - Pharmaceuticals (Lebanon, Indiana) Co

Job DescriptionOverview:From development to commercialization, we partner with Pharmaceutical, Medical Device and Biotechnology clients to provide solutions to complex compliance issues. We collaborate with our partners by providing technical expertise in Quality, Regulatory Compliance and Manufacturing Science and Technology. Our business mission is to ensure our clients exceed their compliance goals while improving patient health and safety. Visit us at www.pharmavise.com and follow us on LinkedIn: https://www.linkedin.com/company/pharmavisecorpOur Fortune 500 Pharmaceutical client has an exciting opportunity for a Commissioning & Qualification (C&Q) LeadJob Summary:The C&Q Lead is responsible for managing the entire Commissioning and Qualification (C&Q) process within Good Manufacturing Practice (GMP) regulated environments. This role requires a deep understanding of validation practices for equipment and systems, along with the ability to align cross-functional project teams and support continuous process improvement. The C&Q Lead will manage project deliverables, guide the team on validation practices, and ensure adherence to regulatory standards, including FDA and GMP guidelines.Responsibilities and Job Requirements:•Lead and execute the C&Q process, facilitating alignment sessions and supporting the implementation of new processes.•Provide clear guidance on using C&Q templates, drafting and updating critical C&Q plans, such as the Project Validation Plan and Test Plan.•Track and resolve C&Q action items, ensuring accurate documentation and compliance.•Offer expertise on validation standards (e.g., GAMP, ISPE, ICH) and regulatory requirements, including FDA regulations for medical devices and combination products.•Oversee document reviews and approvals, monitoring C&Q 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 C&Q alignment.•Create a staffing model to support C&Q activities, manage support staff, and participate in essential project meetings.•Handle administrative tasks, including access requests for validation platforms like Kneat, and engage in Design Review sessions and Site Acceptance Testing (SAT) activities.Minimum Qualifications:•10+ years of experience as a Commissioning & Qualifications Lead in a Pharmaceutical setting.•Bachelor's Degree or Advanced Degrees (Master of Science and PhD) 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 (GAMP, ISPE, and ICH) and regulatory requirements, particularly 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 (OEMs) for design reviews, Factory Acceptance Testing (FAT), and Site Acceptance Testing (SAT), including extended presence for entire review periods.Other Details:•Schedule: 40 hours per week•Contract Length: 12 months•Location: Lebanon, Indiana•Set-up: HybridEEO Employer: Pharmavise Consulting Corp. is an equal opportunity employer. We do not discriminate or allow discrimination on the basis of race, color, religion, creed, sex (including pregnancy, childbirth, breastfeeding, or related medical conditions), age, sexual orientation, gender identity, national origin, ancestry, citizenship, genetic information, registered domestic partner status, marital status, disability, status as a crime victim, protected veteran status, political affiliation, union membership, or any other characteristic protected by law. Pharmavise Consulting Corp. will consider qualified applicants with criminal histories in a manner consistent with the requirements of applicable law. If you have visited our website in search of information on employment opportunities or to apply for a position, and you require accommodation in using our website for a search or application, please contact info@pharmavise.com.Pharmavise Consulting Corp. is a regulatory compliance consulting firm that partners with Pharmaceutical, Medical Device and Biotechnology clients. When you join Pharmavise, you become part of a team that values Excellence Through Quality.E-Verify Participation:Pharmavise Consulting Corporation participates in E-Verify and will provide the federal government with your Form I-9 information to confirm that you are authorized to work in the U.S. If E-Verify cannot confirm that you are authorized to work, Pharmavise is required to give you written instructions and an opportunity to contact the Department of Homeland Security (DHS) or Social Security Administration (SSA) so you can begin to resolve the issue. For more information on E-Verify, please contact DHS at 888-897-7781 or through their website at dhs.gov/e-verify.