Validation Engineer

Job Title:

Validation Engineer IQ/OQ/PQ

Additional

Skills & Qualifications

* 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.

Job Description

The Validation Engineer supports sterile pharmaceutical manufacturing with a strong focus on aseptic sterile fill operations, automated equipment, and early-stage start-up and commissioning environments. This role ensures that manufacturing equipment, processes, utilities, and systems comply with cGMP and global regulatory requirements, including FDA, EMA, and ISO standards. The Validation Engineer leads and supports the full IQ/OQ/PQ validation lifecycle for sterile and automated equipment and works cross-functionally to establish and maintain a compliant validated state throughout early manufacturing and scale-up phases.

Responsibilities

* 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.

Essential Skills

* Bachelor's degree in engineering, life sciences, or a related field.

* 3-5 years of experience in pharmaceutical validation, manufacturing, or process engineering, preferably in aseptic sterile fill facilities.

* Hands-on experience with automated pharmaceutical manufacturing equipment and equipment process validation.

* Experience supporting start-up and commissioning phases for new equipment and early-stage manufacturing environments.

* Strong knowledge of cGMP requirements and global regulatory standards, including FDA, EMA, and ISO.

* Demonstrated experience with validation documentation, including authoring and reviewing validation protocols and reports.

* Experience working with validation tools such as validators and temperature/relative humidity data loggers.

* Strong understanding of equipment and process validation in sterile manufacturing and aseptic processing operations.

* Excellent technical writing skills with strong attention to detail.

* Proven ability to work cross-functionally with Manufacturing, Quality, Engineering, and Automation teams.

* Ability to work independently with minimal supervision and take ownership of assigned responsibilities.

* Proactive mindset with the ability to identify gaps and drive improvements in validation and manufacturing processes.

Work Environment

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…