- Effectively schedule validation activities in co-operation with other departments, company priorities, and department goals.
- Coordinate resources and personnel to achieve company and department goals
- Pre-approve and post-approve qualification protocols.
- Execute protocols and aseptic process simulations.
- Approves the resolution of discrepancies encountered during protocol execution.
- Approves qualification summary reports.
- Investigate and close-out exception reports and non-conformances associated with validation studies.
- Assist in continuous improvement for the department by evaluating systems to improve functionality and efficiency.
- Performs other duties as needed.
Senior Manager Additional Essential Functions:
- Assist in directing the activities and overseeing validation contractors.
- Provide guidance to the validation team in establishing policies, procedures, and strategies consistent with cGMP, International guidance, and the Company’s Quality Programs.
- Assist in the design and implementation of facilities and equipment qualification and validation protocols.
- Assist in the design and implementation of Process Validation Plans that include Facility, Process, and Cleaning.
- Work with manufacturing to design and implement cycle development studies in areas such as sterilization and product contact cleaning assessment validation studies.
- Participate in annual site audits as needed.
- Perform other duties as needed.
Required Skills & Abilities:
- Demonstrated knowledge and experience in process systems associated with the manufacture of a biopharmaceutical product.
- Demonstrated knowledge and experience of cleaning processes.
- Demonstrated knowledge and experience in clean room qualifications.
- Demonstrated knowledge and experience of manufacturing process validation.
- Demonstrated knowledge of cGMP compliance.
- Excellent written and oral communication skills.
- Working knowledge of Microsoft Office products (Outlook, Word, Excel, PowerPoint).
Senior Manager Additional Required Skills and Abilities:
- Hands-on experience in Commissioning, Qualification, and Validation activities (CQV) to include:
- New facility CQV activities and scheduling
- Demonstrated experience in writing and reviewing SOPs and protocols for accuracy, traceability, and compliance.
- Experience in performing and leading validation studies within the pharmaceutical and biotechnology industry.
- Demonstrated ability in problem solving skills and experience applying these skills to resolve technical problems.
Working Conditions & Physical Requirements:
The physical demands described here are representative of those that must be met by an employee to successfully perform the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions. While performing the duties of this job, the employee is regularly required to:
- Experience prolonged sitting, some bending, stooping and stretching.
- Use hand-eye coordination and manual dexterity sufficient to operate a keyboard, photocopier, telephone, calculator, and other office equipment is required.
- Operation of test equipment such as: Kaye validator, fog machine, air sampling equipment.
- Working on ladders.
- Attendance is mandatory.
Validation Senior Manager Minimum Qualifications:
- Bachelor’s Degree preferably in Life Sciences, Chemical or Mechanical Engineering and 8 years of experience in validation activities in facilities commissioning and systems qualification of which 4 years must have been in a supervisory or managerial role.
- Advanced degree
- Biotechnology Certification