Validation Associate III

Life changing therapies. Global impact. Bridge to thousands of biopharma companies and their patients. We are PCI. Our 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. Summary: Under minimal supervision, the Validation Associate III performs complex validation and qualification activities for critical equipment, utilities, and processes used in Drug Product Manufacturing, Quality Control Chemistry, and Microbiology. Essential Duties and Responsibilities: + Validation documentation author for equipment, systems and utilities leveraging novel and complex validation strategies (Validation Protocol and Report Generation). + Performance of Validation (IQ/OQ/PQ) and routine Requalification activities, coordinating with process owners and support teams within projects to prioritize adherence to critical timelines. + Experience supporting cross-functional development of user requirement specification (URS), familiarity with Functional Specifications (FS) and Design Specifications (DS). + Ability to execute demanding physical Validation activities, following protocols and/or procedures, and documenting results on controlled forms in real time with adherence to GDP procedures. + Experience with Kaye Validator AVS and temperature mapping preferred. + Deviation investigation, technical writing and ability to independently own quality events (Deviation, CAPA, Change Controls, etc.) + Represent Validation department in recurring cross-functional or specific meetings as Validation point of contact. + Ownership of assigned projects to meet critical timelines, and escalate challenges to supervisor. + Training, database entry, and regulatory / client audit support. + Regular and reliable attendance on a full-time basis [or in accordance with posted schedule]. + Responsible for exhibiting professional behavior with both internal and external business associates that reflects positively on the company and is consistent with the companyu2019s policies and practices. + Embodies PCI Pharma Services cultural values and aligns daily actions with department goals and company culture. Qualifications: + Bacheloru2019s or Associate degree in Sciences, Engineering, or a similar discipline strongly preferred with a minimum of four (4) years of relevant experience + Minimum of two (2) years of experience supporting GMP operations or similar. + Strong understanding of GMP compliance and regulations + Detail oriented with strong written and verbal communication skills + Ability to work independently within prescribed guidelines or as a collaborative team member. + Experience with Microsoft Office applications + Experience with Kaye Validator operation required The hiring rate for this position is $36.54 - 41.10/hour 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). #LI-AK2 Join us and be part of building the bridge between life changing therapies and patients. Letu2019s talk future ( Equal Employment Opportunity (EEO) Statement: _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._ _At PCI, Equity and Inclusion are at the core of our companyu2019s 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 u2013 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._ Why work for PCI Pharma Services? At PCI, we have an uncompromising focus on providing quality and operational excellence and providing the industry leading customer experience. Our people make all of this happen, so providing an industry leading experience for our people is equally as important. By creating an authentic culture of purposeful work, we aspire to be an interesting and fulfilling place for talented individuals to grow careers. We live a philosophy of intentional learning combined with real-life experience supported by a fair and competitive rewards program. We are individuals, teams and a company that believes in our purpose and our approach is simple, the people who work at PCI fuel our business; we donu2019t say no, we figure out how.PCI Pharma Services is an Equal Opportunity Employer/Vet/Disabled

Created: 2026-03-23