Manager, Validation

Thermo Fisher Scientific Greenville, NC

About the Job

When you’re part of the team at Thermo Fisher Scientific, you’ll do important work, like helping customers in finding cures for cancer, protecting the environment or making sure our food is safe. Your work will have real-world impact, and you’ll be supported in achieving your career goals.

How will you make an impact?

The Manager of Validation Manages a professional support staff and contractors responsible for qualification/validation of all products marketed by the company and produced by the company to include the design, implementation, and documentation of validation for manufacturing equipment, utility systems, facilities, and processes. Represents the department regarding validation issues during FDA meetings and audits. Identifies and resolve validation issues on a timely basis to avoid regulatory action and make recommendations to senior management. Performs a wide range of managerial duties pertaining to employees including hiring, on-the-job training, career development, appraising performance, promoting, disciplining and firing. Identify opportunities and provide the means for employees to pursue career growth.

What will you do?

  • Provides leadership to assigned staff by performing the following: leading organizational change; developing and empowering staff; cultivating relationships; putting staff in a position to succeed, meeting their personal career goals while also achieving organizational goals; building effective teams that apply their diverse skills and perspectives to achieve common goals; driving engagement and creating a climate where staff are motivated to do their best.
  • Manages the activities of several functional groups of the Validation Department consisting of supervisory, professional, and technical employees. Manages design, implementation, and documentation of validation for manufacturing equipment, utility systems, facilities, and manufacturing processes and computer/information./automation validation.
  • Develops, approves, executes, and presents all validation master plans and associated documentation in the NDA drug approval process under the FDA Pre-Approval Inspection programs. Represents the department during audits, meetings, and teleconferences regarding validation issues with the FDA. Provides responses to FDA deficiency letters and audit observations.
  • Manages multi-disciplinary validation teams, approve testing protocol and establish acceptance criteria for validation projects that impact on the production and control of externally produced products, both in clinical supply and trade product manufacturing. Negotiates the scheduling and commitment of specific resources outside the department required for validation projects.
  • Audits, evaluates, and qualifies all vendors or contractors. Negotiates validation requirements with these vendors. Plan and establish technical communications, document flow, testing requirements, and financial resources necessary to produce the validation of the system. Review and approve all vendor-supplied documents. Coordinates the audits of inter-departmental validation programs.
  • Selects bidders, award and administer contracts involving for consulting, laboratory, and process validation engineering services. Prepares and defends five-year plans and annual budgets for the department by assessing manpower and capital needs.
  • Participates in project team activities and process design to insure Current Good Manufacturing Practices (cGMP) compliance as the validation representative on engineering project teams. Develops and maintains a plant wide change control system to review, authorize and document changes to validated systems.
  • Provides process validation guidance to domestic contractors and other subsidiaries of the Company supplying US markets regarding current FDA requirements for facility and product approval. Determines FDA’s current regulatory and enforcement policies regarding process validation of drug manufacturing for domestic and foreign sites and implement procedures accordingly.
  • Represents the Company as an active participant on internal (GQD) and external (ISPE/PDA/PMA) professional committees establishing policy guidelines relating to validation issues.
  • Complies with all job-related safety and other training requirements.
  • Performs other duties as assigned.
How will you get there?
  • Bachelor’s degree in a scientific or production related discipline is required.
Experience:
  • Six years of validation experience including two years of leadership experience is preferred.
Equivalency:
  • Equivalent combinations of education, training, and relevant work experience may be considered.
Competencies:
  • Demonstrated ability to manage and lead professional staff in order to achieve goals, evaluate and resolve complex technical problems. Ability to motivate, energize, and retain key staff by direct interactions with supervisors and staff. Outstanding attention to detail and organizational skills. Self-starter, mature, independent and dependable. Ability to work in a fast paced environment under pressure, able to multi-task and is results-oriented. Demonstrates ability to maintain a high degree of confidentiality. Effective time management and prioritization skills. Requires discretion and independent judgment. Very high degree of interpersonal skills to establish and maintain effective working relationships with employees and the public, including tact to handle sensitive matters. Highly effective verbal and written communication skills.
Physical Requirements:
  • Position requires ordinary ambulatory skills and physical coordination sufficient to move about office locations; ability to stand, walk, stoop, kneel, crouch periodically for prolonged periods of time; manipulation (lift, carry, move) of light to medium weights of 10-35 pounds; arm, hand and finger dexterity, including ability to grasp and type for prolonged periods of time; visual acuity to use a keyboard, computer monitor, operate equipment, and read materials for prolonged periods of time; ability to sit, reach with hands and arms, talk, and hear for prolonged periods of time.

At Thermo Fisher Scientific, each one of our 70,000 extraordinary minds has a unique story to tell. Join us and contribute to our singular mission—enabling our customers to make the world healthier, cleaner and safer.
Apply today! http://jobs.thermofisher.com