Quality Engineering & Validation Specialist

Paragon Bioservices, Inc. (PBI) is a growing Biotech Contract Development and Manufacturing Organization (CDMO) with an internationally recognized tradition of quality and service. Paragon Bioservices provides process development and GMP manufacturing services for Phase I/II clinical trials to industry leaders as well as innovative start-ups utilizing novel technologies to produce state-of-the-art vaccines and therapies for people when they are most in need. As a PBI employee, you will actively contribute to the delivery of our services and products to our customers and their patients.

The Quality Engineer, Validation Specialist is responsible for providing Quality oversight of Paragons Facilities and Equipment Quality Systems to ensure compliance with applicable US regulations, guidance's, industry standards and Paragon policies/procedures supporting the Phase I/II clinical and commercial GMP manufacturing of biological drug substance and drug product. The position will provide continuous improvement support to process, equipment, utilities and computer systems and serve as the key Quality resource for the Engineering, Facilities and Validation organizations.

Shift work and/or weekend work may be required at times.

Key Responsibilities include but are not limited to:

• Serve as the QA liaison with the Facility, Engineering and Validation organizations to support company goals, client projects, continuous improvement initiatives and as a general resource.
• Review and approve Protocols and Summary Reports for Equipment Installation/Operational/Performance Qualifications (IQ/OQ/PQ) used in the manufacture of cell banks, biological drug substance and parenteral drug product in a multi-product facility. Examples of equipment includes fermentors, bioreactors, chromatography systems, controlled temperature units, filling/stoppering machines, autoclaves and critical utilities as well as Cleaning Verification (CV) Studies, Aseptic Process Simulation Studies, Sterilization Validations, Temperature Mapping Studies and other miscellaneous validation activities. Support review of the facility Validation Master Plan (VMP).
• Support the Computerized System Validation Lifecycle to ensure compliance to 21 CFR Part 11, Eudralex Annex 11 and applicable FDA/EMA Guidance's on electronic data integrity. Review and approval of User Requirement Specifications (URS), Computerized System Risk Assessments, 21CFRPart 11/Annex 11 Assessments, Protocols, Test Scripts, Summary Reports and other applicable documentation.
• Provide QA support of the Calibration Program, including review and approval of new calibration procedures, completed calibrations, and compliance to the calibration schedule. Review Out of Tolerances and support investigations evaluating product impact. Familiar with the use of electronic systems used for managing calibration programs such as Blue Mountain, including the review of electronic data, performing queries and printing reports.
• Provide QA support of the Maintenance Program, including QA review and approval of Preventive Maintenance (PM) procedures ensuring their content and frequency are suitable for the intended application, entry of PMs into ProCal. Support other PM and responsive maintenance activities where needed.
• Serve as QA resource supporting the facility and equipment change management program, including review of applicable change controls to ensure appropriate activities are performed and documented supporting the introduction or change to equipment and facilities.
• Support the Risk Management Program to evaluate and mitigate risks associated with equipment and facilities as appropriate using tools such as Failure Modes Effects and Analysis (FMEA), Fault Tree Analysis (FTA) or other available risk management tools.
• Perform other miscellaneous duties including assignment of equipment identification numbers, reviewing GMP engineering drawings, reviewing equipment relocation documentation and updating Equipment History Files.
• Support the program for quarantine and release of GMP cleanrooms in response to environmental disruptions to ensure facilities, utilities and equipment are acceptable for use in GMP manufacturing. Coordinate completion of applicable activities by Facilities, Operations, Quality Control and other applicable Quality Assurance functions.
• Provide QA support, including review and approval, for deviations and investigations related to facilities, equipment, equipment failures and environmental excursions ensuring events are contained, risks mitigated, impacts to equipment, product and processes adequately evaluated, root cause(s) identified and appropriate Corrective and Preventive Actions (CAPAs) implemented. Requires use of available Root Cause Analysis (RCA) tools such as Cause and Effect Diagram or Five Why's.
• Compile and submit pertinent QA metrics for periodic Senior Management review
• Perform periodic walk-through's of Facility Critical Utility areas for HVAC, USP Purified Water Systems, Clean Steam Systems and Compressed Gas Manifolds to review logbooks, verify housekeeping and ensure equipment and utilities are adequately maintained.
• Support regulatory (FDA, EMA) inspections and client/Qualified Person (QP) audits of Paragon
• Support Paragon's Internal Audit Program as needed.
• Continually evaluate systems and procedures for improvement for efficiency while ensuring compliance to applicable regulatory requirements and standards.

Education & Experience:

• Bachelor degree in a Science or Engineering field with 8 years of experience - OR - Master's and 5 years
• Experience supporting the quality assurance of validations associated to IQ, OQ & PQ's working primarily with the Facilities and Engineering teams for biologics manufacturing equipment.
• Experience with aseptic processing
• Have the knowledge, and ability to apply basic scientific and regulatory principles utilized to solve operational, as well as routine quality tasks
• Exposure to 5S and lean sigma desirable
• ASQ CQE (American Society of Quality Certified Quality Engineer) highly desirable

Paragon Bioservices is proud to be an Equal Employment Opportunity and Affirmative Action employer. We do not discriminate based upon race, religion, color, national origin, gender (including pregnancy, childbirth, or related medical conditions), sexual orientation, gender identity, gender expression, age, status as a protected veteran, status as an individual with a disability, or other applicable legally protected characteristics.

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