Validation Engineer

Job Title

Validation Engineer IQ/OQ/PQ

• Experience in aseptic sterile fill manufacturing facilities.
• Experience supporting early-stage manufacturing and start-up facilities, including scale-up environments.
• Involvement in commissioning and qualification phases of new equipment and production lines.
• Ability to operate effectively in a fast-paced, dynamic environment and adapt to changing priorities.
• Strong problem‑solving skills and a self‑starter attitude.
• Willingness to live in or relocate to the Sacramento metropolitan area.
• Willingness to travel occasionally to manufacturing or vendor sites as needed.
• Cleaning validation experience is considered a plus.

• Lead and support the IQ/OQ/PQ validation lifecycle for sterile and automated equipment, including aseptic filling lines, isolators, autoclaves, HVAC systems, and related process equipment.
• Execute equipment and process validation activities to ensure compliance with cGMP and applicable regulatory standards.
• Support facility start‑up, commissioning, and early‑stage manufacturing activities for new and existing production lines.
• Author, review, and approve validation protocols, test scripts, and validation reports with a high level of technical accuracy and clarity.
• Use validation tools such as validators and temperature/relative humidity data loggers to perform qualification and validation testing.
• Collaborate closely with Manufacturing, Quality, Engineering, and Automation teams to define validation strategies and maintain a validated state for equipment and processes.
• Identify gaps in equipment and process validation, propose risk‑based solutions, and drive continuous improvement initiatives.
• Participate in commissioning and qualification activities for new equipment, utilities, and systems in sterile manufacturing operations.
• Support investigations and corrective and preventive actions (CAPA) related to validation, equipment performance, and process deviations as needed.
• Operate effectively in a fast‑paced start‑up or scale‑up environment, taking ownership of assigned validation tasks and delivering on timelines.
• Provide technical input on aseptic processing, sterile fill operations, and automated equipment during project planning and execution.
• Ensure validation documentation is complete, accurate, audit‑ready, and aligned with internal procedures and regulatory expectations.

The role is based in the Sacramento metropolitan area and supports sterile pharmaceutical manufacturing operations in a fast‑paced, early‑stage start‑up or scale‑up environment. The Validation Engineer works on‑site in cGMP‑controlled facilities that include aseptic sterile fill areas, automated filling lines, isolators, autoclaves, HVAC systems, and related process equipment. The position involves frequent collaboration with Manufacturing, Quality, Engineering, and Automation teams, as well as occasional travel to manufacturing or vendor sites.

Work will regularly involve the use of validation tools such as validators and temperature/relative humidity data loggers, along with extensive preparation and review of technical documentation. The environment emphasizes regulatory compliance, technical rigor, and continuous improvement while offering opportunities to contribute directly to the successful start‑up and validation of new sterile manufacturing capabilities.

Permanent position based out of Sacramento, CA. Fully onsite.

Pay range: $90,000.00 - $ per year.

• Health, dental, and vision coverage.
• Paid time off plan.
• 401(k) savings plan.

The company is an equal‑opportunity employer and will consider all applications without regard to race, sex, age, color, religion, national origin, veteran status, disability, sexual orientation, gender identity, genetic information or any characteristic protected by law.

San Francisco Fair Chance Ordinance:
Pursuant to the San Francisco Fair Chance Ordinance, for all positions located in the city and county of San Francisco, we will consider for employment qualified applicants with arrest and conviction records.

Massachusetts Lie Detector:
It is unlawful in Massachusetts to require or administer a lie detector test as a condition of employment or continued employment. An employer who violates this law shall be subject to criminal penalties and civil liability.

Use of Artificial Intelligence (AI):
We may use Artificial Intelligence (AI) to support parts of our hiring process, including sourcing, screening, and evaluating candidates. AI helps assess applications and qualifications, but final decisions are made by our hiring team. By applying, you acknowledge and agree that your application may be reviewed using AI tools.