{"schemaVersion":"jobsearcher.job.v1","id":"f94001b0bd34d994f174054e","url":"https://jobsearcher.com/jobs/f94001b0bd34d994f174054e","canonicalUrl":"https://jobsearcher.com/jobs/f94001b0bd34d994f174054e","title":"Manager, Facilities & Software Validations","description":"Life changing therapies. Global impact. Bridge to thousands of biopharma companies and their patients.\n\nWe are PCI.\n\nOur investment is in People who make an impact, drive progress and create a better tomorrow. Our strategy includes building teams across our global network to pioneer and shape the future of PCI.\n\nSummary of Objective:\nThe 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.\nEssential 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.\nOversees and manages Validations Supervisor(s), engineers, and, as required, other Validations personnel Manage, identify, hire, and develop staff.\nCreate and maintain employee and organizational development.\nOversee proper training, goal setting and effective organizing and assigning of work.\nReviews and approves validation and change control documentation, including protocols, summary reports, etc., for validation activities, process parameters, and validation work practices.\nManage 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.\nAssist with validation harmonization among sites across the PCI Pharma Services organization.\nProvide 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.\nDevelops and administers budgets, schedules and performance requirements and evaluations.\nPlan, execute, and oversee validation of facilities, cleanrooms, and utilities (HVAC, compressed air, water systems, gases).\nDevelop and approve validation documentation including URS, risk assessments, IQ, OQ, PQ, and validation summary reports.\nEnsure facility changes are evaluated through change control and revalidation activities as required.\nSupport environmental monitoring programs and facility qualification strategies.\nLead CSV activities in accordance with GAMP 5, FDA, and ISO requirements.\nDefine validation strategies based on system impact, intended use, and risk.\nReview and approve system lifecycle documentation (URS, FS, DS, risk assessments, test scripts, traceability matrices).\nEnsure data integrity principles (ALCOA+) are applied across computerized systems.\nServe 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.\nParticipates, present and provide rationale for the validation program during periodic audits and regulatory inspection and customer visits/conference calls as required.\nThis position may require overtime and/or weekend work. Performs other duties as assigned by Director.the\n\nQualifications: 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.\nRequired:\nBachelor’s degree in Engineering, Life Sciences, Computer Science, or a related technical discipline.\nMinimum of 6-8 years of experience in facilities, utilities, and computer system validation in a regulated industry (medical devices, pharmaceutical, or biotechnology).\nAdvanced Computer Skills: Ability to perform the most complex computer tasks and operate various computer programs.\nPrior experience supervising or leading validation personnel preferred.\nStrong understanding of validation lifecycle activities (URS, risk assessments, IQ, OQ, PQ, and validation reports).\nIn-depth knowledge of Computer System Validation (CSV) and GAMP 5 methodology.\nWorking knowledge of FDA regulations (21 CFR Parts 820, 210/211, and 11).\nFull Professional Proficiency: Ability to speak, read, and write fluently and accurately on all levels pertinent to professional needs.\nHighest 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.\nHigh Standard of Report Writing\nPreferred:\nAbility to effectively present information to various people as the job requires.\nAbility to identify and resolve problems in a timely manner.\nAbility to display original thinking and creativity.\nAbility to show success in managing employees.\nAbility to demonstrate attention to detail.\nAbility to set and achieve challenging goals.\nThe 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).\n#LI-DT1\nJoin us and be part of building the bridge between life changing therapies and patients. Let’s talk future\nEqual Employment Opportunity (EEO) Statement:\nPCI 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.\nAt PCI, Equity and Inclusion are at the core of our company’s purpose: 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.","company":"Pcipharmaservices","rawCompany":"pcipharmaservices","city":"Bloomington","state":"IL","isRemote":false,"isActive":false,"createdAt":"2026-08-03T19:34:49.912Z","occupations":[{"code":"17-2112.02","title":"Validation Engineers","slug":"validation-engineers"},{"code":"11-3051.01","title":"Quality Control Systems Managers","slug":"quality-control-systems-managers"},{"code":"11-9121.00","title":"Natural Sciences Managers","slug":"natural-sciences-managers"}],"industries":[{"code":"325412","title":"Pharmaceutical Preparation Manufacturing","slug":"pharmaceutical-preparation-manufacturing"},{"code":"541714","title":"Research and Development in Biotechnology (except Nanobiotechnology)","slug":"research-and-development-in-biotechnology-except-nanobiotechnology"},{"code":"541715","title":"Research and Development in the Physical, Engineering, and Life Sciences (except Nanotechnology and Biotechnology)","slug":"research-and-development-in-the-physical-engineering-and-life-sciences-except-nanotechnology-and-biotechnology"}],"jobPosting":{"@context":"https://schema.org","@type":"JobPosting","title":"Manager, Facilities & Software Validations","description":"Life changing therapies. Global impact. Bridge to thousands of biopharma companies and their patients.\n\nWe are PCI.\n\nOur investment is in People who make an impact, drive progress and create a better tomorrow. Our strategy includes building teams across our global network to pioneer and shape the future of PCI.\n\nSummary of Objective:\nThe 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.\nEssential 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.\nOversees and manages Validations Supervisor(s), engineers, and, as required, other Validations personnel Manage, identify, hire, and develop staff.\nCreate and maintain employee and organizational development.\nOversee proper training, goal setting and effective organizing and assigning of work.\nReviews and approves validation and change control documentation, including protocols, summary reports, etc., for validation activities, process parameters, and validation work practices.\nManage 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.\nAssist with validation harmonization among sites across the PCI Pharma Services organization.\nProvide 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.\nDevelops and administers budgets, schedules and performance requirements and evaluations.\nPlan, execute, and oversee validation of facilities, cleanrooms, and utilities (HVAC, compressed air, water systems, gases).\nDevelop and approve validation documentation including URS, risk assessments, IQ, OQ, PQ, and validation summary reports.\nEnsure facility changes are evaluated through change control and revalidation activities as required.\nSupport environmental monitoring programs and facility qualification strategies.\nLead CSV activities in accordance with GAMP 5, FDA, and ISO requirements.\nDefine validation strategies based on system impact, intended use, and risk.\nReview and approve system lifecycle documentation (URS, FS, DS, risk assessments, test scripts, traceability matrices).\nEnsure data integrity principles (ALCOA+) are applied across computerized systems.\nServe 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.\nParticipates, present and provide rationale for the validation program during periodic audits and regulatory inspection and customer visits/conference calls as required.\nThis position may require overtime and/or weekend work. Performs other duties as assigned by Director.the\n\nQualifications: 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.\nRequired:\nBachelor’s degree in Engineering, Life Sciences, Computer Science, or a related technical discipline.\nMinimum of 6-8 years of experience in facilities, utilities, and computer system validation in a regulated industry (medical devices, pharmaceutical, or biotechnology).\nAdvanced Computer Skills: Ability to perform the most complex computer tasks and operate various computer programs.\nPrior experience supervising or leading validation personnel preferred.\nStrong understanding of validation lifecycle activities (URS, risk assessments, IQ, OQ, PQ, and validation reports).\nIn-depth knowledge of Computer System Validation (CSV) and GAMP 5 methodology.\nWorking knowledge of FDA regulations (21 CFR Parts 820, 210/211, and 11).\nFull Professional Proficiency: Ability to speak, read, and write fluently and accurately on all levels pertinent to professional needs.\nHighest 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.\nHigh Standard of Report Writing\nPreferred:\nAbility to effectively present information to various people as the job requires.\nAbility to identify and resolve problems in a timely manner.\nAbility to display original thinking and creativity.\nAbility to show success in managing employees.\nAbility to demonstrate attention to detail.\nAbility to set and achieve challenging goals.\nThe 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).\n#LI-DT1\nJoin us and be part of building the bridge between life changing therapies and patients. Let’s talk future\nEqual Employment Opportunity (EEO) Statement:\nPCI 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.\nAt PCI, Equity and Inclusion are at the core of our company’s purpose: 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.","datePosted":"2026-08-03T19:34:49.912Z","dateModified":"2026-08-03T19:34:49.912Z","hiringOrganization":{"@type":"Organization","name":"Pcipharmaservices","sameAs":"https://jobsearcher.com"},"jobLocation":{"@type":"Place","address":{"@type":"PostalAddress","addressLocality":"Bloomington","addressRegion":"IL","addressCountry":"US"}},"identifier":{"@type":"PropertyValue","name":"JobSearcher","value":"f94001b0bd34d994f174054e"},"url":"https://jobsearcher.com/jobs/f94001b0bd34d994f174054e"}}