Systems Verification and Validation Engineer​/Scientist II

Systems Verification and Validation Engineer/Scientist II

(cGMP documentation experience in a pharmaceutical/biopharmaceutical environment)

Pay – $38.00 - $40.00. Rate may be negotiable based on experience, education, geographic location, and other factors.

This position serves as the primary liaison between Facilities Engineering and cross‑functional stakeholders, including Project Management, Validation, and Quality, ensuring that all documentation meets cGMP and site quality requirements.

• Serve as the primary Engineering Documentation interface for Project Management, Validation, and Quality.
• Develop and manage procedures and periodic review schedules for GMP As‑Built and Non‑GMP Master Drawings.
• Maintain a master inventory of GMP and Non‑GMP drawings (electronic and hard copy) utilizing the Adept Documentation System.
• Manage CAD services using the Adept CAD system, ensuring drawing accuracy and compliance.
• Support internal and regulatory cGMP inspections; maintain audit‑ready documentation.
• Provide oversight to project contractors to ensure adherence to site documentation standards.
• Support deviations, CAPAs, and Change Controls, including documentation and implementation activities.
• Manage EDMS workflows for document routing, review, and approval.
• Update and maintain CMMS work orders related to engineering drawings (Blue Mountain preferred).
• Perform additional responsibilities as assigned by Facilities & Engineering leadership.
• Ensure documentation meets cGMP and site quality requirements.
• Maintain compliance with applicable regulatory requirements.
• Coordinate and prioritize to meet milestones and timelines in a technical and results‑oriented environment.

• Bachelor’s degree in a technical or related field is preferred.
• Knowledge of cGMPs, local/Federal regulatory requirements, and documentation procedures pertaining to a biopharmaceutical manufacturing plant.
• Minimum three (3) years’ experience in CAD drafting and engineering documentation in a regulated industry.
• Working knowledge of cGMP requirements and quality systems.
• Experience with EDMS and controlled documentation systems.
• Experience with CMMS systems (Blue Mountain preferred).
• Strong understanding of applicable regulatory requirements.
• Strong interpersonal and communication skills; written and oral.
• Comfortable supporting concurrent issues and working in an exciting, ambitious, and fast‑paced environment.
• High ethical standards to support a professional business code of conduct.
• Ability to coordinate and prioritize to meet milestones and timelines in a highly technical environment.
• Comfortable with aseptic or sterile gowning as needed.

• Write, read, and review documentation for extended periods.
• Specific vision requirements: close vision, distance vision, color vision, peripheral vision, depth perception, and ability to adjust focus.
• Required to ascend/descend stairs (approximately 20% of the time), lift a maximum of 50 lbs., and sit for a maximum of 4 hours.
• Occasionally required to lift, walk, use hands to finger, handle, or feel; reach with hands and arms; stoop, kneel, or crouch.
• Required to wear Personal Protective Equipment (PPE).

Veterans/Disabled

Benefit offerings available for our associates include medical, dental, vision, life insurance, short‑term disability, additional voluntary benefits, an EAP program, commuter benefits, and a 401K plan. Our benefit offerings provide employees the flexibility to choose the type of coverage that meets their individual needs. In addition, our associates may be eligible for paid leave including Paid Sick Leave or any other paid leave required by Federal, State, or local law, as well as Holiday pay where applicable.

Disclaimer:
These benefit offerings do not apply to client‑recruited jobs and jobs that are direct hires to a client.

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The Company will consider qualified applicants with arrest and conviction records in accordance with federal, state, and local laws and/or security clearance requirements, including, as applicable:

• The California Fair Chance Act
• Los Angeles City Fair Chance Ordinance
• Los Angeles County Fair Chance Ordinance for Employers