Validation Associate III

PCI Pharma Services • San Diego, CA

14h • $37 - $41

About The Position

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.

Requirements

• 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

Nice To Haves

• Experience with Kaye Validator AVS and temperature mapping preferred.

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.

Benefits

• 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).

What This Job Offers

• Job Type: Full-time
• Career Level: Mid Level
• Number of Employees: 1-10 employees