What are the responsibilities and job description for the Validation Manager position at AMERICAN REGENT, INC.?
Nature and Scope
The Validation Manager will be responsible for developing and managing all aspects of the validation program for the Brea facility. This will include supervision of department personnel as well as hands-on execution of qualification and validation protocols and equipment qualifications. The position is responsible for ensuring that all validation and qualification activities are performed within an appropriate level of cGMP compliance.
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.
- Manage the validation program to meet regulatory expectations and continue to improve validation systems to meet industry standards.
- Manage the development and implementation of activities in the validation department. This includes site activity scheduling, coordination, risk assessments, adherence and escalations as needed.
- Manage validation projects which support the existing facilities, equipment and processes on site.
- Maintain accurate tracking of validation studies, equipment and facility status.
- Provide leadership and direction to ensure department performance is in line with the business plan and quality systems.
- Draft and review IQ, OQ, PQ, and revalidation protocols for process equipment, facility utilities and sterilization and cleaning processes utilized for cGMP processes.
- Oversee and execute approved protocols, analyze test results applicable to qualifications and draft technical reports summarizing qualification activities.
- Review revalidation trending packages for various equipment and utilities used for cGMP processes.
- Identify requirements to ensure the validated state of equipment / facility / processes are maintained to keep business unit performance on target.
- Initiate and review deviations, out of tolerance notifications, change controls and CAPAs related to validation and maintenance / metrology activities if applicable
- Review routine monitoring activities for the facility (includes but is not limited to routine monitoring of validated storage chambers / areas and pressure differential of cleanroom suites).
- Participate in inspection readiness activities and involved in inspections by regulatory agencies.
- 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 field of science, required.
- Minimum 7 years performing validation activities in a Pharmaceutical or similar FDA regulated environment, required.
- 5 years of leadership in Validation or project management experience, required.
- 3 years of people management experience, required.
- Strong knowledge of cGMP regulations and practices pertaining to validation principles, manufacturing processes, automated process control and monitoring systems, quality systems, engineering design fundamentals, regulatory agency expectations and industry trends, required.
- Technical documentation skills.
- Project management skills.
- Good verbal, written and interpersonal communication skills.
- Comfortable in a fast-paced small company environment and able to adjust workload based on changing priorities and business needs.
- Ability to think critically with demonstrated troubleshooting and problem-solving skills.
- Proficient with Microsoft Office (Excel, Word, Outlook).
- Working knowledge of FDA cGXP regulations is required.
- Experience developing and executing equipment impact assessments and validation test protocols in a pharmaceutical cGMP regulated environment.
Physical Environment and Requirements
- Physically able to wear cleanroom/protective gowning and equipment, including but not limited to gowning, goggles, face shields, respirators, and protective gloves. PPE and Respirators are essential for the health and safety of employees.
- Employees must maintain a clean-shaven appearance each working shift to wear tight-fitting respirators properly.
- Employee must be able to occasionally lift and/or move up to 25 pounds.
- Ability to sit or stand for prolong periods of time.
- Fine and gross motor skills to manipulate equipment and tools.
Expected Salary Range:
$115,000-140,000
The salary range displayed is the minimum and maximum hourly rate of compensation for the role that the employer in good faith believes to be accurate at the time of the posting of an advertisement for the role. Actual compensation for the role will be based on a number of different factors including but not limited to the candidate’s qualifications, education, knowledge, skills and experience.
American Regent also offers a competitive total rewards package which includes healthcare, life insurance, profit sharing, paid time off, matching 401k as well as a wide range of other benefits.
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
American Regent Inc. endeavors to make https://americanregent.com/Careers accessible to any and all users. If you would like to contact us regarding the accessibility of our website or need assistance completing the application process, please email hrtalentacquisition@americanregent.com.
Salary : $115,000 - $140,000
