Thermo Fisher Scientific Senior Validation Manager in Cincinnati, Ohio
Manages a professional support staff responsible for process validation of all products produced, to include the design, implementation, and documentation of validation for manufacturing equipment, utility systems, facilities, cleaning, computer system, packaging and manufacturing processes. Negotiates specific process validation criteria and required resources. Coordinates interdepartmental process validation programs. Represents the department regarding validation during audits. Identifies and resolve validation issues on a timely basis and makes 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, and disciplining. Identify opportunities and provide the means for employees to pursue career growth.
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 designs, implementation, and documentation of validation for manufacturing equipment, utility systems, facilities, and manufacturing processes and computer/information/automation validation.
Represents the department during audits, meetings, and teleconferences regarding validation. Provides responses to agency and audit observations.
Manages multi-disciplinary validation teams, approve protocol and establish acceptance criteria for validation projects that impact on the production and control of produced products. Negotiates the scheduling and commitment of specific resources outside the department required for validation projects.
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.
Complies with all job-related safety and other training requirements.
Performs other duties as assigned.
Bachelor’s degree in a scientific or production related discipline is required. Advanced degree preferred.
10 years of validation experience including 5 years of leadership experience is preferred.
Equivalency: Equivalent combinations of education, training, and relevant work experience may be considered.
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.
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.
If you are an individual with a disability who requires reasonable accommodation to complete any part of our application process, click here at https://jobs.thermofisher.com/page/show/eeo-affirmative-action-statement#accessibility for further assistance.
Thermo Fisher Scientific is an EEO/Affirmative Action Employer and does not discriminate on the basis of race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, disability or any other legally protected status.
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