Manager / Senior Manager, Validation

POSITION SUMMARY:

Precigen is seeking a Manager / Senior Manager, Validation, to provide CQV leadership for our GMP manufacturing site in Germantown, Maryland. Key accountabilities include ensuring that the GMP facility and equipment comply with regulatory commissioning, qualification, and validation requirements for late stage clinical / commercial GMP manufacture of biopharmaceuticals. This role will also manage relationships with contract service providers while working cooperatively with internal stakeholders such as manufacturing, quality, QC, facilities, and metrology personnel.

Estimated travel commitment for this role will be less than 10%.

DUTIES AND RESPONSIBILITIES:

• Accountable for the ownership of the site Validation Master Plan (VMP)
• Coordinate writing, review, and execution of IQ, OQ, and PQ protocols for GMP facility and GXP equipment (manufacturing and lab equipment).
• Develop and maintain site commissioning, qualification, and validation (CQV) standard operating procedures (SOP).
• Accountable for execution of computer system validation, data integrity, and ALCOA principles on GXP qualified equipment and software applications while working closely with IT.
• Provide oversight and responsibility for the site shipping validation process.
• Responsible for cleanroom airflow visualization studies and associated validation documentation for ISO classified and CNC spaces.
• Author procedures, policies, and regulatory audit responses.
• Develop and provide leadership on system impact, system boundary, and component criticality assessment process.
• Author and/or review system risk assessments, factory/site acceptance protocols, validation plans, commissioning plans, design qualifications, functional specifications, system design documentation, and user requirement specifications.
• Lead periodic reviews and system re-qualification process for GXP equipment.
• Develop and report on key validation metrics that drive continuous improvement within the GMP facilities organization.
• Support regulatory and internal audits.
• Collaborate effectively with site quality on all aspects of GXP systems.
• Provide leadership with respect to the validated state of operation when investigating, troubleshooting, and resolving problems that occur during routine operations related to facilities, engineering, QC, and manufacturing.

EDUCATION AND EXPERIENCE:

• Bachelor’s Degree in Life Sciences or Engineering and at least five (5) years of validation experience in increasing levels of responsibility in GMP facilities, GXP equipment, and cleanroom operations within a /biotech/pharma organization or equivalent. Equivalent combination of education and experience may be substituted for the above, as applicable. Level of role will be determined based on experience.
• Understanding of cGMPs and operation of a biotech/pharma manufacturing facility.
• Experience with IQ/OQ/PQ documentation and validation lifecycle in a pharmaceutical or related environment.
• Knowledge and understanding of computer system validation and data integrity ALCOA principles.
• Hands on experience working with quality systems, including change/deviation management as well as implementation of CAPAs.
• Strong knowledge of Good Documentation Practices used within a pharmaceutical or equivalent environment.
• Ability to read and understand technical manuals and calibration reports for the setup and installation of GXP equipment.
• Hands on experience operating common equipment used for qualification of GXP equipment such as temperature loggers, smoke machines, biological indicators, etc
• Exceptional organizational skills and attention to detail required.
• Acumen for teaching/training and excellent communications and supervisory skills required.
• Advanced technical writing proficiency required.
• Experience using basic project management principles with respect to managing validation projects.
• Hands-on experience with statistical modeling and analysis, is a plus.

DESIRED KEY COMPETENCIES:

• Highly organized with strong personal leadership and self-direction.
• Well-developed interpersonal skills and demonstrated ability to work with and coordinate demands from multiple customers, both internally and with partners.
• Experienced participation in a regulatory audit or inspections.
• Demonstrated attention to detail and ability to effectively manage own projects and priorities.
• Strong oral and written communication skills and an ability to communicate complex concepts in a concise, simplified manner.
• Ability to prioritize effectively and maintain adherence to project timelines and commitments with competing priorities
• Ability to understand and execute the company’s mission and values.
• Clear communication in both oral and written form.
• Demonstrated ability to work and coordinate with multiple stakeholders.
• Exhibition of the highest degree of ethical standards and trustworthiness.
• Able to safely access difficult to reach mechanical spaces, ladder/steps to roof, and successfully obtain gowning qualification for cleanroom access. Ability to safely lift up to 30 pounds.

WORK ENVIRONMENT:

Frequent: Speaking; hearing; sitting; use of hands/fingers; handling or feeling objects, tools or controls; close vision; color vision; peripheral vision; ability to adjust focus.

Occasional: Standing; walking indoors; reaching with hands and arms; stooping; kneeling; crouching; lifting and/or move up to 30 lbs.

General: Moderate noise level, similar to typical office environment with computers, printers and light traffic

EOE MFDV