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 company’s policies and practices.
• Embodies PCI Pharma Services cultural values and aligns daily actions with department goals and company culture.

Qualifications:

• Bachelor’s 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).

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Join us and be part of building the bridge between life changing therapies and patients. Let’s 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 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.