21 Sep
|
Jones Healthcare Group
|
Winnipeg
21 Sep
Jones Healthcare Group
Winnipeg
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 requirementsOwn and maintain the Validation Master Plan to support ongoing packaging operations and lifecycle validation activitiesDevelop, review, and approve validation protocols and reports, including IQ/OQ/PQ, cleaning validation, equipment qualification, utilities, facilities, and computer systems validationEnsure validation activities are executed effectively through coordination, training, and collaboration with cross‑functional teamsSupport investigations, deviations, change controls,
and risk assessments from a validation and compliance perspectivePartner with Engineering and Operations to assess new equipment and systems for validation readiness and data integrity requirementsManage validation schedules, priorities, and resources to ensure projects are completed on time without compromising quality or complianceLead technology transfer and onboarding activities for new client projects to ensure smooth, compliant, and efficient implementationReview technical assessments, project plans, and change controls to ensure validation requirements are appropriately incorporatedEnsure Good Documentation Practices and ALCOA principles are consistently maintained throughout all validation activitiesMaintain validation documentation and archives to support audit readiness and efficient document retrievalWrite and improve validation‑related SOPs and support continuous improvement initiatives across the businessProvide leadership, coaching, and performance management for direct reports while fostering a collaborative, accountable,
and growth‑oriented team environmentBuild strong working relationships with internal stakeholders and external customers to support successful project outcomes and a robust validation cultureQualificationsA 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 validationStrong knowledge of cGMP requirements, validation principles, and regulatory expectations within a pharmaceutical environmentExcellent communication and technical writing skills, with the ability to clearly communicate across teams and levels of the organizationStrong organizational and project management skills with the ability to manage multiple priorities and timelinesExperience leading projects, mentoring team members, and managing validation and technology transfer activities is considered a strong assetA collaborative mindset with the ability to work independently while building solid cross‑functional partnershipsHigh attention to detail and a commitment to quality, compliance, and continuous improvementStrong technical and computer proficiency, including the ability to navigate complex systems, equipment, and documentation processesBenefitsCompetitive compensation in the range of $97,000 – $130,000 per year, based on job‑related knowledge, skills, and experienceValues‑led culture: Ingenuity, Nimble, Supportive, Inclusive, Driven, EmpatheticRRSP program – match up to 5% of earningsComprehensive benefits program including healthcare spending accountVacation and floater daysSpecial local discountsEmployee and family assistance programReferral bonusesEducation reimbursement programColleague appreciation eventsAnd more#J-18808-Ljbffr
📌 Validation Manager - $97,000 - $130,000 A Year (Winnipeg)
🏢 Jones Healthcare Group
📍 Winnipeg