PSC Biotech is a leading Biotech Consultancy firm founded in 1996, headquartered in Pomona, California, employing a global team of skilled professional and experts that span across strategically located offices in the United States, Europe, Asia, and the Middle East. PSC operates in 52 countries globally and has served thousands of clients to date.
We focus on providing quality consulting services to ensure our client’s success. PSC provides cost-effective solutions, while providing exceptional technical capabilities and customer service to our clients for all projects ranging from supplier quality audits to greenfield projects. We understand that the world of life science is evolving rapidly, and we must continue to offer new products and services to meet our customer’s expectations.
We are looking for a mid-level Validation Engineer to support decommissioning tasks. The ideal candidate will have at least 3-6 years of experience, be flexible and adaptable, and able to produce results in a fast paced, collaborative environment. The candidate should demonstrate strong analytical skills and have experience in the medical device, pharmaceutical, and/or biotech industry.
Development and editing of all technical documentation including (SOPs, User Requirements and Design Specifications, Commissioning and Qualification Protocols, Monitoring Reports, Trending Reports)
Development of project plans, as appropriate
Execution of validation test procedures
CAPA and Change Management
Thermal mapping of temperature-controlled chambers and warehouses
Technical report writing
Performs/executes/validation/verification studies (FAT, SAT, IQ, OQ, PQ) for cleaning, shipping, equipment, systems, utilities, and processes for qualification/verification and/or re-qualification/re-verification.
BS in Engineering, Science or equivalent technical degree.
3-6+ years’ experience in a regulated, manufacturing environment within the biotechnology, pharmaceutical or medical device industry.
Experience in the areas of design documentation (URS, FS, DS and other engineering specifications) Validation (IQ, OQ, PQ, PV, CV, CSV, etc.), Quality Systems (Change Control, Non-Conformances, Requalification, etc), and Process Excellence Methodologies (Six-Sigma, Lean, etc.).
Excellent written and verbal communication skills; excellent technical writing skills.
Strong interpersonal skills and the ability to work in a team environment.
Ability to work effectively in a fast paced multitasking environment.
Strong working knowledge of FDA and cGMP regulations and documentation practices.