Senior Quality Validation Specialist

Cellares•Bridgewater, NJ

2d•$90,000 - $210,000•Onsite

About The Position

We are seeking an innovative and highly motivated Senior Quality Validation Specialist, who will contribute significantly to the growth of the Cellares team. The Quality Validation team at our IDMO Bridgewater facility will be responsible for providing Quality Assurance oversight of environmental, equipment (analytical and production), facility & utility, site automation, process validation & engineering documents, test protocols, CAPAs, deviations, change control records, and additional site based technical documentation and activities. This individual will work closely with cross-functional teams to maintain high standards of quality in a regulated environment. Candidates should enjoy working in a fast-paced, mission-driven environment, and be prepared to tackle a broad selection of challenges as the company grows.

Requirements

Bachelor’s degree in a scientific or engineering discipline
5 to 8 years of experience in a GMP environment in pharmaceutical, biologics, vaccines, cell or gene therapy operations, including solid experience in Quality Systems and Regulatory CMC
2+ years of direct experience in quality or validation, and demonstrated knowledge of relevant cGMP regulations
Excellent knowledge of the regulations for biologics, cell and gene therapy products
Strong knowledge of current Good Manufacturing Practices (GMP); experience with on-site regulatory inspections is desirable
Comprehensive knowledge of global GMP and regulatory requirements for biotechnology, cell and gene therapy products and Quality by Design approaches
Excellent understanding of risk management and CAPA processes
Ability to understand and interpret complex scientific issues across multiple projects as it relates to regulatory requirements and strategy

Nice To Haves

Experience with computerized systems validation (CSV) is a plus.

Responsibilities

Review and approve complex documentation in support of GMP operations at the IDMO, including but not limited to facility plans, validation, CSV and other technical protocols and reports, trend reports, risk assessments, standard operating procedures, CAPAs, deviations, etc.
Author and maintain the IDMO Site Validation Plan
Provide Quality oversight of process validation studies and process performance qualifications
Provide oversight of cleanroom lifecycle programs including aseptic process simulations, environmental monitoring performance qualification, cleanroom certification & recertification, cleaning & sanitization, and facility controls
Proactively identify & resolve technical and compliance issues/gaps
Provide support to multiple areas within and, potentially, between facilities, requiring a high level of regulatory, Quality System, facility, equipment and process knowledge
Ensure adherence to internal procedures and industry/regulatory expectations related to facility/equipment controls and release before, during and after production operations (i.e. routine operations – calibration/maintenance, shutdowns, construction projects, etc.)
Collaborate with stakeholders within and outside of the IDMO Facility, and communicate equipment, facility and system status; monitor progress and issue status reports
Act as Quality Engineering Subject Matter Expert for responsible areas/projects during client or regulatory inspections
Drive continuous improvement and increase efficiency and productivity