Validation Supervisor

Nature and Scope

The incumbent will provide direct supervision for internal and external validation resources. The Validation Supervisor will be responsible for establishing both validation and re-validation policies and programs for multiple-site aseptic manufacturing operations. The position will oversee a wide range of activities assuring that processes, systems, facilities and equipment comply with accepted Good Manufacturing Practices utilizing a life-cycle approach. The position will support company directives ensuring compliance objectives are met and sustained and that projects and work adhere to schedule.

Essential Duties and Responsibilities

Nothing in this job description restricts management's right to assign or reassign duties and responsibilities to this job at any time.

• Utilizing a life-cycle approach, determine and establish validation/re-validation requirements for a wide range of processes, facilities, systems and equipment, consistent with company directives and regulatory expectations. Develop and maintain all necessary Validation Plans, including strategies, work schedule/timelines, and resource planning/requirements. Develop and maintain/update Validation SOPs to ensure consistent application of the requirements and strategies.
• Direct resources to ensure validation timelines are met. Ensure all personnel (internal and contractors) utilized to perform validation activities have the appropriate resources, skill set and required trainings.
• Coordinate, manage and where required, perform the following:
  • Risk assessments for validation testing with participation of QA, RA, Production, R&D, and Engineering
  • Protocol development/ review/approval, protocol execution, discrepancy and report generation
  • Training of personnel performing validation activities
  • Support development of other lifecycle documentation including user/ system requirements, risk assessment, design qualification, review and approve site procedures
  • Resolution of test failures and deviations; ensure sound compliance rationale is developed and documented
• Support validation review of investigations and change management as well as facility inspections, audits (both performed by internal groups and by regulatory agencies), regulatory submissions and annual product reviews.
• Manage the activities of direct reports to accomplish scope of work of validation department.
• Provide effective leadership including: individual goal setting/performance reviews, managing the development of employees, recognizing and appreciating employee contributions, mitigating conflict and communication problems, planning and facilitating team activities, selecting personnel and motivating members of the functional area.
• Perform any other tasks/duties as assigned by management.

Education Requirements and Qualifications

To perform this job successfully, an individual must be able to perform each essential duty satisfactorily. The requirements listed below are representative of the knowledge, skill and/or ability required.

• Bachelors' Degree in Life Science, Engineering or a related field, or equivalent years of experience, required.

• Minimum 5 years performing validation activities in a Pharmaceutical or
• or similar FDA regulated environment.

• 1 year of leadership or project management experience required.
• Strong knowledge of cGMP regulations and practices pertaining to validation principals, manufacturing processes, automated process control and monitoring systems, quality systems, engineering design fundamentals, regulatory agency expectations and industry trends.
• Proficient in Microsoft Office Suite required.
• Good technical writing skills.
• Excellent communication, problem-solving, planning and organization skills.
• Ability to work independently with little supervision.
• Ability to function within a team structured work environment
• Ability to work off hours and weekends.

Physical Environment and Requirements

Physically able to wear cleanroom/protective gowning and equipment, including but not limited to gowning, goggles, face shields, and protective gloves. PPE is essential for the health and safety of employees.

American Regent celebrates diversity and we are committed to creating an inclusive environment for all employees. We are an Equal Opportunity Employer and all qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability status, or protected veteran status.

Applicants have rights under Federal Employment Laws.

• FMLA poster: https://www.dol.gov/whd/regs/compliance/posters/fmlaen.pdf
• Know Your Rights: Know Your Rights: Workplace discrimination is illegal (eeoc.gov)
• Employee Polygraph Protection Act: https://www.dol.gov/whd/regs/compliance/posters/eppac.pdf

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