Senior Quality Assurance Engineer

Location: Germantown, MD, US

GENERAL DESCRIPTION:

The Senior Quality Assurance Engineer is responsible for providing Quality oversight of Precigen’s Facilities, Engineering and Validation groups to ensure compliance with applicable US regulations, guidance's, industry standards and Precigen’s policies/procedures supporting the clinical and commercial GMP manufacturing of biological drug substance. This position will provide continuous improvement support to process, equipment, utilities and computer systems and serve as the key QA resource for the Engineering, Facilities and Validation department.

DUTIES AND RESPONSIBILITIES: 

• Serve as the QA liaison with the Facility, Engineering and Validation department to support Precigen’s goals and continuous improvement initiatives to meet project timelines, provide deliverables and resolve issues.
• 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 approve Protocols and Validation Summary Reports for Validation activities such as Engineering studies, Cleaning Validation including Disinfectant Efficacy Studies, Shipping Validation Studies etc.
• Review and approve equipment qualification protocols (IQ/OQ/PQ) for various equipment such as controlled temperature units, autoclaves and critical utilities. Support review of the facility Validation Master Plan (VMP).
• 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.
• Serve as the QA resource for expansion projects which includes construction of cleanrooms, commissioning, and qualification of utilities such as HVACs, Process Gases, and EMPQ of cleanrooms.
• 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
• Serve as QA resource supporting the facility and equipment investigation management program, including review of deviation, CAPA and Effectiveness check records to ensure appropriate activities are performed and documented.
• Provide QA support to the Calibration Program, including review and approval of new calibration plans/procedures, completed calibrations, and compliance to the calibration schedule.
• Provide QA support to the Maintenance Program, including QA review and approval of Preventive Maintenance (PM) plans/procedures ensuring their content and frequency are suitable for the intended application.
• Review and approve Standard Operating Procedures (SOPs).
• Participate in the site quality and process improvement initiatives. Support regulatory (FDA, EMA, etc.) audits/inspections of Precigen.
• Other duties as assigned.

EDUCATION AND EXPERIENCE:

• Masters’ degree in a Scientific, Engineering or Biotech field with 6 years’ experience within the biologic, pharmaceutical or medical device industry performing direct hands-on work in a Quality function OR
• Bachelor’s degree in a Scientific, Engineering or Biotech field with 8 plus years’ experience within the biologic, pharmaceutical or medical device industry performing direct hands-on work in a Quality function.
• Strong knowledge of global regulatory and CGMP compliance standards.
• Experience with Quality Assurance aspects of product development for early through late clinical phases.
• Experience performing/supporting validations associated with IQ, OQ & PQ for Controlled Temperature Units (CTUS’s) such as freezers, refrigerators, incubators, autoclave and biologics manufacturing equipment.
• Experience with Facility Expansion and Aseptic Processing is a plus.
• Strong knowledge base with Good Manufacturing Practices (GMPs), 21 CFR Parts 210, 211, biological regulations per 21 CFR Parts 600s, ICH Guidelines and EU GMPs.
• Experience in writing change controls, deviations and investigations.
• Certified Quality Engineer from American Society for Quality (ASQ) is a plus.

DESIRED KEY COMPETENCIES:

• Ability to understand and execute the company’s mission and values.
• Strong analytical and decision-making skills with attention to detail and quality.
• Exhibits impeccable confidentiality on sensitive, supporting tasks.
• Ability to anticipate and solve problems while analyzing complex issues and environments.
• Ability to communicate and work effectively with all levels of employees in various communication mediums.
• Possess a high degree of personal responsibility under minimum supervision.
• Ability to adapt and succeed in a milestone-driven, rapidly changing product development and commercialization environment.
• Ability to prioritize and re-prioritize activities as needed to accomplish unanticipated requests or initiate new projects requiring immediate attention.
• Exceptional planning, organization, and execution skills.
• Demonstrates the highest ethical standards and trustworthiness.
• Strong verbal and written communication and interpersonal skills.

EOE MFDV