PCI Pharma Services

Manager, Facilities & Software Validations

Rockford, IL, USA · Full-time

Sponsorship not specified$109k-$123kDetected 5 days ago

ComplianceGMPFDA RegulatoryMedical Devices

About the role

Bridge to thousands of biopharma companies and their patients.
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.

Create and maintain employee and organizational development.
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.
Develop and approve validation documentation including URS, risk assessments, IQ, OQ, PQ, and validation summary reports.
Support environmental monitoring programs and facility qualification strategies.
Develops and administers budgets, schedules and performance requirements and evaluations.
Lead CSV activities in accordance with GAMP 5, FDA, and ISO requirements.
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.
This position may require overtime and/or weekend work. Performs other duties as assigned by Director.the
Our investment is in People who make an impact, drive progress and create a better tomorrow.

The requirements listed below are representative of the knowledge, skill, and/or ability required for the stated position.
Bachelor's degree in Engineering, Life Sciences, Computer Science, or a related technical discipline.
Ability to set and achieve challenging goals.
Reasonable accommodation may be made to enable individuals with disabilities to perform the essential functions.

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.
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.

The hiring rate for this position is $108,960.00 -$122,580.00 plus eligibility for an annual performance bonus.

Together, delivering life-changing therapies.
We are committed to cultivating an inclusive workplace by holding ourselves accountable to the highest standards of understanding, fairness, respect, and equal opportunity - at every level.
We envision a PCI community where everyone can belong and grow, and we strive to bring this vision to reality by continuously and intentionally assessing our people practices, policies and programs, marketing approach, and workplace culture.
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.
Provide technical expertise and guidance to customers, the Validations department as well as working with the range of internal departments.

PCI Pharma Services is an Equal Opportunity/Affirmative Action Employer.
We do not unlawfully discriminate on the basis of race, color, religion, age, sex, creed, national origin, ancestry, citizenship status, marital or domestic or civil union status, familial status, affectional or sexual orientation, gender identity or expression, genetics, disability, military eligibility or veteran status, or any other protected status.

We do not unlawfully discriminate on the basis of race, color, religion, age, sex, creed, national origin, ancestry, citizenship status, marital or domestic or civil union status, familial status, affectional or sexual o

This listing is sourced directly from PCI Pharma Services's careers page and normalized into a canonical job model.