34790 Ardentech Court Fremont, CA 94555
Bayside Solutions is seeking a Validation Engineer to be part of our Client’ s team in Fremont. This is an opportunity to work with a clinical-stage biopharmaceutical company focused on providing systemic administration of therapeutics to patients using our proprietary Adhesive Dermally-Applied Microneedle, or ADAM technology.
Our Company Bio: Bayside Solutions was founded in 2001, Bayside was recognized as one of the fastest growing professional staffing companies in Northern California. The numbers tell the story: We have close to a 100% client retention rate, 700% growth in four plus years and over 95% repeat business. Our dedication to building partnership relationships with both our clients and our recruits is the key to our phenomenal success.
You can find additional information on our company website at www.baysidesolutions.com.
- An opportunity to join a company focused on the development and delivery of novel, targeted drugs for treating a variety of therapeutic areas.
- Work for a company that is local to the bay area, in the beautiful South San Francisco area.
- Competitive compensation commensurate with experience.
- This position is eligible for medical, vision, dental benefits, paid sick time, and 401K.
Summary of Responsibilities:
The Validation Engineer will be responsible for activities related to validating the equipment and process for a new commercial line and the associated support equipment. Validation will include confirming that mechanical, electrical, and automation systems as well as process validation work meet the defined user requirements. The candidate will be responsible for strategic planning, generating and approving validation protocols, overseeing and executing validation protocols and writing validation summary reports. The candidate will also manage validation efforts with equipment manufacturers and commercial manufacturing organizations from FAT to Process Validation. The position will require 20-30% travel.
- Develop and manage the Validation Program
- Strategic development and design of Validation Master Plans.
- Draft or review qualification documents including IQ, OQ, PQ and PV.
- Support Factory Acceptance Test (FAT) and Site Acceptance Testing (SAT) for new equipment.
- Execute, manage and support validation activities at CMO’ s.
- Develop strategies for Process Qualification.
- Review validation documents executed by CMO’ s (Protocols, executed documents, and Reports).
- Assess validation deviations.
- Bachelor’ s Degree in Engineering (Mechanical or Electrical Preferred) with 5-8 years of experience in Biotechnology or Medical Devices with an emphasis on validation.
- Have experience with writing and execution IQ/OQ/PQ’ s and process validation activities.
- Working knowledge of design control and Quality Risk Management principles.
- Working knowledge of statistics used to support validation justification.
- Working knowledge of cGMP and Good Documentation Practices.
- Possess good communication skills and be capable of managing complex programs and be knowledgeable of cGMP manufacturing and validation concepts.