Summary of Objective: The Facilities and Software Validations Manager is responsible for coordinating and managing all validation efforts related to Facility/Utility and Computer Equipment at multiple facilities. The Validations Manager is responsible for designing, maintaining and continually improving the validation system. The Validations Manager is responsible for implementation and ongoing improvements of the validation policies, protocols and testing. Provide technical expertise and guidance to customers, the Validations department as well as working with the range of internal departments. Coordinate with other departments to communicate validations and provide resources to implement protocol executions. The Facilities and Software Validations Manager assures customer requirements are accurately incorporated into PCI systems and assures validation protocols adhere to cGMP requirements.
Essential Duties and Responsibilities: To perform this job successfully, an individual must be able to perform each essential duty satisfactorily. The essential duties and responsibilities include the following but other duties may be assigned.
- Oversees and manages Validations Supervisor(s), engineers, and, as required, other Validations personnel Manage, identify, hire, and develop staff.
- Create and maintain employee and organizational development.
- Oversee proper training, goal setting and effective organizing and assigning of work.
- Reviews and approves validation and change control documentation, including protocols, summary reports, etc., for validation activities, process parameters, and validation work practices.
- Manage and develop facility, utility, and computer validations program that is in compliance with regulatory and customer expectations, which includes developing and maintaining Validation Master Plan and policy and work practices. Design, maintain and continually improving the validation system in line with current national and international standards.
- Assist with validation harmonization among sites across the PCI Pharma Services organization.
- Provide Validation technical expertise and guidance to the groups within the organization and customers on validation policies and procedures and the implementation of those within the Operations and Quality Assurance (QA) functional areas.
- Develops and administers budgets, schedules and performance requirements and evaluations.
- Plan, execute, and oversee validation of facilities, cleanrooms, and utilities (HVAC, compressed air, water systems, gases).
- Develop and approve validation documentation including URS, risk assessments, IQ, OQ, PQ, and validation summary reports.
- Ensure facility changes are evaluated through change control and revalidation activities as required.
- Support environmental monitoring programs and facility qualification strategies.
- Lead CSV activities in accordance with GAMP 5, FDA, and ISO requirements.
- Define validation strategies based on system impact, intended use, and risk.
- Review and approve system lifecycle documentation (URS, FS, DS, risk assessments, test scripts, traceability matrices).
- Ensure data integrity principles (ALCOA+) are applied across computerized systems.
- Serve as a risk management representative on cross-functional and multi-site teams to support integrating risk management into various product quality systems such as Change Control and CAPA.
- Participates, present and provide rationale for the validation program during periodic audits and regulatory inspection and customer visits/conference calls as required.
- This position may require overtime and/or weekend work. Performs other duties as assigned by Director.the
Qualifications: The requirements listed below are representative of the knowledge, skill, and/or ability required for the stated position. Reasonable accommodation may be made to enable individuals with disabilities to perform the essential functions.
Required:- Bachelor's degree in Engineering, Life Sciences, Computer Science, or a related technical discipline.
- Minimum of 6-8 years of experience in facilities, utilities, and computer system validation in a regulated industry (medical devices, pharmaceutical, or biotechnology).
- Advanced Computer Skills: Ability to perform the most complex computer tasks and operate various computer programs.
- Prior experience supervising or leading validation personnel preferred.
- Strong understanding of validation lifecycle activities (URS, risk assessments, IQ, OQ, PQ, and validation reports).
- In-depth knowledge of Computer System Validation (CSV) and GAMP 5 methodology.
- Working knowledge of FDA regulations (21 CFR Parts 820, 210/211, and 11).
- Full Professional Proficiency: Ability to speak, read, and write fluently and accurately on all levels pertinent to professional needs.
- Highest Reasoning Ability: Ability to apply principles of logical or scientific thinking to a wide range of intellectual and practical problems and deal with nonverbal symbolism in its most difficult phases while dealing with concrete/abstract variables.
- High Standard of Report Writing
Preferred: - Ability to effectively present information to various people as the job requires.
- Ability to identify and resolve problems in a timely manner.
- Ability to display original thinking and creativity.
- Ability to show success in managing employees.
- Ability to demonstrate attention to detail.
- Ability to set and achieve challenging goals.
The hiring rate for this position is $108,960.00 -$122,580.00 plus eligibility for an annual performance bonus. Final offer amounts are determined by multiple factors including but not limited to specific and relevant experience, education, credentials, geography, and subject matter expertise. PCI offers full-time employees a competitive benefits package that includes paid time off, health insurance coverage (including dental and vision), flexible spending account, and 401(k).
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