We are looking for an experienced Validation Engineer to join our exciting and rapidly growing biotech client. Interested applicants must be local to the area and have equipment, method, and process validation experience.
Overview: The Quality Validation Engineer serves as the primary specialist resource for development, execution, review, and approval of a variety of equipment and processes that are critical to the quality systems, production environment and laboratory spaces for the company. Primary responsibilities cover validation and FDA-compliance related documents/protocols for equipment qualification, (including laboratory equipment), process validation, test method Validation and related change controls to assure compliance with cGMPs in a medical device environment.
Responsibilities:
- Author, review, execute and approve technical documentation, plans, protocols, and reports. This includes but is not limited to Equipment Qualification, Process Validation, Test Method Validation, related change controls, and SOPs for IVD and RUO products. Computer System Validation experience is helpful but not essential.
- Supports equipment qualification and requalification: laboratory instruments/systems, processing equipment, temperature controlled equipment, etc.
- Lead and Participate in quality- and process improvement initiatives and projects.
- Stays current with changes to GMP, including FDA, EU, ISO, and other regulatory bodies as well as guidance documents related to validation.
- Interact frequently with Laboratories, Manufacturing, QC and Facilities to provide expertise on equipment qualification and validation. Address conditions/practices with appropriate personnel; report findings to executive management as necessary.
- Works on routine assignments per written procedures; ability to recognize deviation from accepted practice.
- Participates and supports specific safety and quality responsibilities for department and site (i.e., GMP, Audits, Environment, and Health & Safety).
- Works and collaborates cross-functionally, primarily with R&D/Product Support, Industrial Operations, QC and Facilities.
- Manages and coordinates the use of third parties for the Installation and operational qualification of new equipment/Instruments/systems.
- Maintain the Validation Master Plan (VMP).
- Participates in cross-functional design, development and investigative activities (root cause analysis) especially in support of validation and qualification activities.
- Support and actively participate in third party audit and regulatory inspection activities
Requirements:
- Bachelor’s degree in a scientific or engineering (BioMedical, Mechanical Chemical Engineering etc), Biotechnology or Pharmaceutical Science, Quality Assurance, Manufacturing or similar is ideal.
- Minimum 3+ years’ experience in a GMP, FDA, and ISO regulated environment.
- Previous quality engineering experience / managing qualification and validation activities
