Validation Manager

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Working in Western Canada, (location TBA), for this global leading bio-pharma firm with opportunity for growth, providing strategic, essential products before, during & after Covid-19!

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The Validation Manager job itself where you will provide oversight of Facilities and Engineering Validation department to ensure support for the lifecycle of the company’s equipment, utilities, and related processes. The job role functions include management and development of employees, document review for regulatory submission, participation in regulatory inspection and response activities, and responsibility for performance, resource, and budget management.  More specifically:

• Provides oversight of Validation processes for critical equipment, facilities, utilities, computerized systems, data integrity, cleaning, sterilization and shipping.
• Responsible for the qualification of equipment and procedures used for Cold Chain processes, including storage and transport.
• Responsible for the verification of the continued performance of critical systems, equipment and processes under a Validation Maintenance plan.
• Develops and provides oversight for Project, Cleaning, Equipment, and Facility master plans.
• Develops Validation systems, reviews commissioning and qualification reports for major projects.
• Responsible for the assessment of deviations/laboratory investigations and proposed changes for impact to validated systems. 
• Represents Facilities and Engineering Validation and Emergent during FDA and other regulatory agency inspections. 
• Completes FDA inspection response reports, response updates, and coordinates response and gap analysis teams
• Validation approver of CTDs for submission to FDA (CBER)
• Provides oversight, reviews and approves Validation SOPs, site Risk Analysis, Deviations, CAPAs and Change Controls. 
• Plans and tracks budgetary requirements. Responsible for resource management and resource modeling for equipment, instrumentation, supplies, and personnel.
• Provides routine reports regarding budgetary updates and variances against approved budgets.
• Participates in review of contract negotiations for potential customers (specific to review of sections pertaining to Validation).
• Define metrics that exhibit productivity and throughput in functional area and maintains metrics.
• Communicates metrics, trends, and data summaries to senior management using a variety of media: intranet, reports, and presentations.
• Leads and supports initiatives ensuring department and site Validation compliance including training, communication forums, and continuous improvement.
• Manages employees with various experience levels with capability to develop new leaders, individual contributors, and technical experts.
• Conducts personnel interviews, performance reviews, develops and administers development plans, and provides feedback to group.
• Performs functions associated with the recruitment and hiring process for Facilities and Engineering Validation positions.

You will have

To be successful as the Validation Manager you will have validation technical knowledge in a variety of fields, and solid written and oral communication skills.  

• A Bachelor’s degree in Engineering, Science or equivalent field; (will give consideration to an equivalent level of experience). 
• Minimum of 5-7 years of relevant pharmaceutical industry cGMP experience is required.
• Previous experience in new facility commissioning and validation. Experience with DeltaV and PLC systems preferred.
• Highly desirable to have minimum of 5 years of supervision experience or demonstrated leadership experience.
• Previous experience working with FDA (CBER) and participating in regulatory agency inspections.
• Must have SOP, investigation, and project protocol writing skills and demonstrated ability to critically evaluate content of such documents.
• The position requires excellent communication, human relations, organizational skills, and the ability to manage with leadership and independence.
• Must have the ability to tailor communications to all levels with effective communication skills for ‘upward’ and ‘downward’ audiences.
• Highly desirable to have prior experience with developing and maintaining department budgets.
• Capacity to integrate technical detail, regulatory and quality standards and business judgment into concrete requirements and action priorities.
• Must be able to prepare reports for internal metrics and technical content and prepare reports and data summaries for FDA review.  
• Must have competence of cGMPs, ICH guidance, Eudralex.

You will get

As Validation Manager, you will enjoy highly competitive salary $Negotiable + Benefits + Relo

You can apply

To Validation Manager by pushing the button on this job posting (recommended), by sending CV in confidence to anthony@macstaff.co.uk  or give me a call at 01275 331307.

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