Senior Validation Manager

Position Summary

The Validation Senior Manager will lead a team of validation professionals and Validation Section Managers to ensure plant validation practices and operating procedures meet ICU Medical policies and are harmonized with industry standards. The candidate will also be responsible for driving validation strategy based on strong technical and scientific rationale based on engineering or product specification and or process development studies. The manager will lead different validation activities, manage resources, and collaborate with cross-functional teams to meet project timelines within the given budget. The manager will be responsible for ensuring the site manages validation changes in a compliant manner and Validation KPIs, budget and projects are on target.

Essential Duties & Responsibilities

• The Sr. Validation Manager will be responsible for the control costs and the management of financial resources for validation to meet budgetary requirements for both department expenses and validation capital budgets.

• The Sr. Validation Manager will develop, implement and maintain KPIs with the Validation Section Managers and provide periodic reports of the team’s performance to Senior Site Leadership.

• Ensures the validation policies and procedures are in accordance to cGMP regulations and industry standards. If needed, the candidate will work the Validation Section Managers to develop and define SOPs and validation procedures to improve validation training program.

• The Sr. Validation Manager will work with the Validation Section Managers to create processes, policies and programs for the validation department to ensure that the pre-requisites for qualifications are met and well documented

• The Sr. Validation Manager will collaborate with Engineering, Manufacturing, QA, MS&T, and or R&D to develop and maintain a strong commissioning program identifying risk to failures in proactive manner and work to drive a mitigation plan to ensure successful execution of validation activities.

• Develops and ensures proper execution of validation plans for facilities, utilities, critical equipment, control systems, processes, and software etc. This includes validation, periodic reviews, continuous process verifications and revalidation.

• Serve as primary interface for validation matters with regulatory and third-party representatives and when needed for R&D, technical resources, and vendors.

• Provide oversight, direction and counsel to other site functions on validation matters: investigations, CAPA management and process improvements related to validated systems.

• Will coordinate validation support for complex projects to meet or exceed project timelines. This may include networking with external firms and onboarding expertise needed for a particular project.

• Prioritize and manage the overall validation resources (staff, equipment, and funds) to meet diverse and aggressive goals for validation compliance.

• Provide initial estimation of the resources and budgetary impact for the different validation strategies.

• The candidate will successfully manage validation contract resources, maintaining a network of validation vendors, efficiently using validation contractors as required for temporary assignment or project work as required to support the successful completion of all periodic compliance and project related validation deliverables.

• Facilitate the Plant Validation Steering Committee to gain consensus on priorities and schedules, which consolidates the compliance and business needs.

• Use Project management tool to track and communicate project milestones. Be creative in resolving conflicts with project resources and timelines.

• Works with validation personnel or validation section managers to generate statements of work or other scope definitions to obtain consultant quotes, issue purchase order, process invoices.

• Develop technical validation training to plant personnel as required.

• Perform other related duties as assigned or required.

Knowledge & Skills

• Must have good organizational, presentation, meeting facilitation and technical writing skills.

• Must have strong communication and interpersonal skills.

• Demonstrated leadership skills include providing direction, influencing others, fostering teamwork, motivating others, delegating, coaching/developing others in a team-oriented environment and championing change. Successful candidates must have experience in leading technical professionals.

• Demonstrated flexibility and the ability to handle multiple projects.

• Ability to drive for results and show work commitment.

• Must have ability to analyze complex technical and process data, understand verbiage and intent of Governmental and Company regulations, evaluate potential solutions, and determine the most compliant and cost-effective approach to solve problems.

• Must act with integrity, show resilience in the face of challenges.

• Must have demonstrated skills to think strategically, technically, analyze issues, use sound judgment and be innovative.

• Could work extended days, weekends and holidays as required to meet deadlines.

Minimum Qualifications, Education & Experience

• Must be at least 18 years of age

• Bachelor’s degree from an accredited college or university is required; Applicable fields: Engineering or Science.
• Incumbent must have a minimum of fifteen (15) years’ experience in a pharmaceutical GMP environment in one or more of the following disciplines: Validation, Process/Product Engineering cGMP Compliance or Quality. Experience must include at least ten (10) years in direct validation role and seven (7) years of managerial experience including supervision of exempts.
• Candidates with other technical Bachelor’s degrees will be considered if they have fifteen (15) or more years of direct validation experience. Management or Business Administration Courses are desirable.
• Must have extensive experience talking/dealing with regulatory and third-party representatives.

Work Environment

• This is largely a sedentary role.

• This job operates in a professional office environment and routinely uses standard office equipment.

• Work will occasionally require entry into operational areas, clean room environments and laboratory settings

• Typically requires travel less than 5-20% of the time