Validation Section Manager - Austin, United States - ICU Medical

Description

FLSA Status:
Exempt


Position Summary:

The Validation Section Manager will lead a team of validation professionals and ensure plant validation practices and operating procedures meet ICU Medical policies and industry standards.

The candidate will also be responsible for driving validation strategy based on strong and document technical rationale.

The section manager will lead different validation activities, manage resources, and collaborate with cross-functional teams to meet project timelines within the given budget.

The section 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:

• Ensures the validation policies and procedures are in accordance to cGMP regulations and industry standards. If needed, the candidate will work to clearly and succinctly define SOPs and validation procedures to improve validation training program.
• The section manager will ensure that the pre-requisites for validations are met and well documented by collaborating with engineering, MS&T, and or R&D before initiating validations. Section manager will also be responsible for identifying risk to failures in proactive manner and work to drive a mitigation plan to ensure successful execution of validation activities.
• Ensures validations are performed appropriately through the review of all phases of validation, i.e. design, validation, continued process verification.
• Develops and ensures proper execution of validation plans for facilities, utilities, critical equipment, control systems, and software etc. This includes validation, periodic reviews and revalidation.
• Serve as subject matter expert and 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.
• Coordinate 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.
• Assists with the development of metrics, dashboards, score cards, and tracking and trending for validated equipment, facilities, utilities, systems, etc. Track and maintain validation KPIs to communicate progress on projects.
• Use Project management tool to track and communicate project milestones. Be creative in resolving conflicts with project resources and timelines.
• Obtain consultant statements of work, issue purchase order, process invoices.
• Provide technical validation training to plant personnel.
• Participate and facilitate, as needed, the Plant Validation Review Board.
• Perform other related duties as assigned or required.

Knowledge, Skills & Qualifications:

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

Working knowledge of statistics is preferred.

• 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.
• 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.
• Experience with CSV (Computer Systems Validation), Data Integrity, 21 CFR part 11, and ALCOA principals preferred.

Education and Experience:

• Must be at least 18 years of age.

Bachelor's Degree is required:
Engineering or Science. Other technical degrees will be considered with commensurate experience.

• A minimum of five (5) years' validation experience in an FDA regulated environment is required. Previous supervisory experience is strongly preferred.
• Must have extensive experience talking/dealing with regulatory and third-party representatives.

Physical Requirements and Work Environment:

• Generally, an office environment with few physical demands.
• Enter in manufacturing or cleanroom environments as needed.
• Typically requires travel less than 5% of the time

ICU Medical is an Affirmative Action and Equal Opportunity Employer.

All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, or protected veteran status and will not be discriminated against on the basis of disability.