OverviewValidation plays a critical role in ensuring the quality, safety, and compliance of our products and operations. In this role, you will lead and oversee the Packaging Services site validation program, ensuring processes, equipment, utilities, facilities, and systems remain in a validated and compliant state throughout the product lifecycle. This is more than writing protocols and reviewing documentation – it’s about building confidence in our operations, supporting successful client launches, and creating a culture where compliance and continuous improvement go hand in hand. You will provide leadership across both validation and technology transfer activities, balancing technical expertise, project management, and people leadership to support business growth and regulatory success. Working closely with cross‑functional teams across Engineering, Operations, Quality Assurance, and Technical Services, you will help drive operational excellence while ensuring alignment with regulatory and cGMP requirements. ResponsibilitiesLead the execution and continuous improvement of the site Validation Program to ensure compliance with cGMP and regulatory requirements Own and maintain the Validation Master Plan to support ongoing packaging operations and lifecycle validation activities Develop, review, and approve validation protocols and reports, including IQ/OQ/PQ, cleaning validation, equipment qualification, utilities, facilities, and computer systems validation Ensure validation activities are executed effectively through coordination, training, and collaboration with cross‑functional teams Support investigations, deviations, change controls, and risk assessments from a validation and compliance perspective Partner with Engineering and Operations to assess new equipment and systems for validation readiness and data integrity requirements Manage validation schedules, priorities, and resources to ensure projects are completed on time without compromising quality or compliance Lead technology transfer and onboarding activities for new client projects to ensure smooth, compliant, and efficient implementation Review technical assessments, project plans, and change controls to ensure validation requirements are appropriately incorporated Ensure Good Documentation Practices and ALCOA principles are consistently maintained throughout all validation activities Maintain validation documentation and archives to support audit readiness and efficient document retrieval Write and improve validation‑related SOPs and support continuous improvement initiatives across the business Provide leadership, coaching, and performance management for direct reports while fostering a collaborative, accountable, and growth‑oriented team environment Build strong working relationships with internal stakeholders and external customers to support successful project outcomes and a robust validation culture QualificationsA Bachelor’s degree in Science or Engineering (Mechanical or Chemical Engineering preferred) 5+ years of pharmaceutical or relevant technical experience, including hands‑on experience with validation programs such as process, cleaning, facility, equipment, or computer systems validation Strong knowledge of cGMP requirements, validation principles, and regulatory expectations within a pharmaceutical environment Excellent communication and technical writing skills, with the ability to clearly communicate across teams and levels of the organization Strong organizational and project management skills with the ability to manage multiple priorities and timelines Experience leading projects, mentoring team members, and managing validation and technology transfer activities is considered a strong asset A collaborative mindset with the ability to work independently while building strong cross‑functional partnerships High attention to detail and a commitment to quality, compliance, and continuous improvement Strong technical and computer proficiency, including the ability to navigate complex systems, equipment, and documentation processes BenefitsCompetitive compensation in the range of $97,000 – $130,000 per year, based on job‑related knowledge, skills, and experience Values‑led culture: Ingenuity, Nimble, Supportive, Inclusive, Driven, Empathetic RRSP program – match up to 5% of earnings Comprehensive benefits program including healthcare spending account Vacation and floater days Special local discounts Employee and family assistance program Referral bonusesEducation reimbursement program Colleague appreciation events And more#J-18808-Ljbffr