Validation Manager

About Jones Healthcare Group

Jones Healthcare Group is a world-class provider of advanced packaging and medication dispensing solutions. With roots firmly established in healthcare, Jones has been a long-time, trusted partner for some of the most recognized global pharmaceutical brands and the largest pharmacy groups, independent pharmacies, hospitals and long-term care facilities across the world.

Imagine working at Jones, where we embrace our commitment to the environment, team members, communities, and consumers – and we’re inspired to package the future of healthcare.

Learn more about our story here: www.joneshealthcaregroup.com.

What our colleagues are saying:

“I love the people, the positive organizational culture, my team and the genuine spirit of cooperation and shared goals. I’m very optimistic about my professional growth and development and the value that I hope to bring to the company.”

Benefits we offer:

• A safe, respectful, and inclusive environment
• Competitive compensation and equitable people practices
• Comprehensive benefits and an RRSP program where we match up to 5% of your earnings
• Opportunities to grow and develop, alongside a supportive team
• Employee and family assistance program
• Referral bonuses
• Education reimbursement program
• Colleague appreciation events
• and more!

Summary of position

If you love working to ensure Compliance and Quality Assurance in every process, following regulatory standards and validating data, then this is the right position for you.

If you get excited about understanding relevant regulations, industry standards, and guidelines for ensuring compliance during the validation process, then this position is a perfect fit for you.

If you are naturally task-oriented with keen attention to detail, along with excellent report writing and communication skills, then you’ll want to consider this opportunity.

Responsible for the execution and regulatory compliance of the validation program, the Validation Manager is well-versed in the generation, execution, modification, and summation of Validation documents to ensure Good Documentation Practices within pharmaceutical operations. This role serves to ensure products and processes are maintained in a validated state and compliant with regulatory and cGMP requirements throughout the product lifecycle. This is accomplished through interaction and coordination of activities with all relevant departments within the organization.

Here are some of the different activities you’ll be asked to do:

• Ensure validation programs are established and maintained to meet regulatory and cGMP requirements that impacts the products and processes.
• Own and manage the Validation Master Plan as required to ensure validation principles are current and appropriate to support cGMP packaging operations throughout the product life cycle, including ongoing validation assessment and evaluation
• Prepare Validation Protocols addressing all pertinent critical functionality and limits for equipment and processes required to be validated (IQ/OQ/PQ). Ensure protocols provide:
• A high degree of assurance that a specific equipment or process will consistently produce a product meeting its predetermined specifications and quality attributes
• Assurance of the establishment of engineering and procedural controls as required by cGMP
• Responsible and accountable for the overall execution of Validation Protocols through coordination and training of applicable departments to meet the requirements set forth in the respective protocol
• Write reports that summarize and assess impact of the results generated through the Validation Protocols. Where required, recommend corrective measure(s) with the objective of attaining validated status
• Evaluate new equipment from a validation and data integrity perspective through participation with Engineering and Operations to ensure that new purchases will be capable of meeting validation and data integrity requirements
• Write and revise Validation related SOPs, and make suggestions for improvement of current SOPs as required
• Manage the planning of the Validation program to ensure its on-time completion to the schedule and committed action
• Support product and facility investigations as required from a validation perspective in order to assess impact and make recommendations to remediate and/or mitigate against risks to the process and facilities
• Act as the Change Management champion from a validation perspective to ensure processes and the facility remain in a validated state
• Establish and maintain strong relationships with internal and external customers to achieve desired outcome of a robust and compliant validation program. Provide leadership and guidance on new and/or existing validation topics
• Maintain Validation documentation archive ensuring prompt document retrieval when required during audit requests or investigations
• Ensure Good Documentation Practices and ALCOA principles are adhered to throughout the Validation activities

If you’ve got:

• A Bachelor’s degree in Science or Engineering (mechanical or chemical preferred)
• 5 years of pharmaceutical or relevant technical experience, including direct experience in any combination of cleaning, facility, and process validation programs is an asset
• Excellent verbal and written communication
• High degree of computer proficiency and the ability to navigate technical systems
• Knowledge of the principles and application of current GMP guidelines related to Validation activities
• Ability to work both independently and in a team

We’d like to hear from you!

Please submit your resume and let us know why you are interested.

While we thank all candidates for their interest, only those selected for an interview will be contacted.

As part of our commitment to accessibility for all persons with disabilities, Jones Healthcare Group will, upon the request of the applicant, provide accommodation during the recruitment process to ensure equal access to applicants with disabilities. Please contact the Jones Human Resources department at 1.800.265.9093 about your needs, and we will consult with you to ensure suitable accommodation is provided.

For all feedback on equity and accommodation needs, please also contact the Human Resources department.