Manager, Pharmaceutical Validation
The Manager, Pharmaceutical Validation is within the Engineering Team and is responsible for development and management of the NorthStar validation program and validation personnel. The scope of the work controlled by this position includes Pharmaceutical/Isotope/Medical Device Manufacturing Equipment/Facilities Assessment (for product quality impact), Commissioning (GMP and non-GMP), and Qualification (IQ/OQ).
ESSENTIAL DUTIES AND RESPONSIBILITIES include the following, other duties may be assigned:
1. Develop and drive the overall validation strategy for NorthStar Manufacturing systems through cross functional teams including quality, engineering, and manufacturing as well as outside consultants.
2. Lead and personally develop procedures in line with the strategy
3. Provide subject matter expertise to development teams on how to create validation protocols and strategies.
4. Ensure compliance (both internally and externally) of the NorthStar Equipment Commissioning and Qualification program, as it exists now and possible future iterations. A program which governs how equipment is received and assessed, commissioned and qualified, and is managed under proper change control throughout its lifecycle. Management of this program consists of, but is not limited to:
a. Working with interdisciplinary teams as needed to refine the Equipment Commissioning and Qualification program
b. Cyclic Validation Master Plan (VMP) and site specific validation master record updates
c. Development and execution of Validation Project Plans (VPP) as necessary
d. Development and execution of Commissioning and Qualification plans and protocols
e. Coordinating external Commissioning and Qualification contractors to ensure internal compliance
f. Continued education to stay current on latest requirements and trends within commissioning and qualification activities
g. Develop and maintain an appropriate budget which forecasts external validation costs
5. Ensure that personnel are performing assigned tasks to standard and receive professional mentoring and development to stay current on internal policies and external requirements and trends as they apply to their specific role.
6. Effectively communicate safety and quality issues raised by customers or staff in a timely manner.
7. Support NorthStar’s Quality System and Health & Safety Program by following policies and procedures.
Ability and willingness to travel up to 15% of the time.
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. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.
EDUCATION and/or EXPERIENCE
Bachelor’s Degree in Engineering or Science and five or more years of progressive relevant experience; or equivalent combination of education and experience. Two or more years of managerial experience required.
Experience developing and executing equipment impact assessments and validation test protocols for production facilities and equipment in a Pharmaceutical cGMP regulated environment required.
Proficient knowledge of Microsoft Office software programs, including Outlook, Word, Excel, and Project. Experience with a CMMS preferred.
Provide an interactive, problem solving environment to address any weaknesses within the team. Responsibilities include: interviewing, hiring, and training employees; planning, assigning, and directing work; appraising performance; rewarding and disciplining employees; addressing complaints and resolving problems.
• Excellent communication skills, verbal and written
• Strong attention to detail
• Ability to handle multiple projects simultaneously
• Ability to work in a team environment, as well as independently
• Ability to work in a fast-paced environment
• Adaptable to change in the work environment
If you are interested in applying for this position, please forward your resume to [email protected] with the position title in the subject line