Sr. Qualification/ Validation Engineer
Fremont, CA | Contract
Bayside Solutions is seeking a Sr. Qualification/ Validation Engineer to be part of our client’ s team in the East Bay. This is an opportunity to work with the largest privately held pharmaceutical corporation in the world and ranks among the world' s 20 leading pharmaceutical corporations.
Our Client’ s culture is highly collaborative, offers an environment that encourages employees to expand their knowledge in order to make a profound impact on patients’ lives. This could explain why their company has been recognized as one of the “ Top Twenty Employers” in biotechnology and pharmaceuticals by Science Careers.
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.
Sr. Qualification/ Validation Engineer
- An opportunity to join a patient-focused organization that is driven to develop, manufacture and commercialize medicines to treat life threatening conditions.
- Work for a company that is local to the bay area and recognized as a leader of innovation.
- Competitive compensation commensurate with experience.
- This position is eligible for medical, vision, dental benefits, paid sick time, and 401K.
Summary of Responsibilities:
- Lead/manage validation projects including:
- Provide risk assessment for new systems and changes to existing systems
- Write validation plans, protocols and reports
- Execute and provide reviews of validation protocols and validation periodic monitoring
- Lead or participate in project team including the supervision of validation contractors
- Provides estimates of validation resource requirements.
- Bachelors Degree in science or engineering, from an accredited university or college. Advanced degree, MBA or Masters in science or engineering is preferred.
- Greater than 10 years of relevant cGMP biopharmaceutical manufacturing environment experience in validation/qualification
- At least 5 years must be recent experience with validation/qualification of typical manufacturing equipment and/or computer systems at a multi-product biopharmaceutical manufacturing facility.
- Experience in 3 or more GMP validation disciplines (Process Equipment, Utility (including HVAC), Laboratory, Automation, Computer Systems, Sterilization, Sterile Filling/Isolator) with advanced technical knowledge
- Knowledge of Validation Lifecycle Approach (URS, FRS, FAT/SAT, Commissioning Protocols, etc) guidelines, international regulatory requirements and standards (GMP, ICH Q7, Q8, Q9, Q10 and other international regulatory requirements
- Proven skill in use of thermal mapping equipment in validating, Autoclaves, Tanks, and other temperature controlled units
- Validation experience using risk based approach (FMEA, PHA, etc)
- Excellent technical writing and verbal communication skills
- Ability to read/interpret engineering drawings and design documents
- Ability to work as part of a high performing team and collaborate effectively with staff at all levels.
- Must have well-developed interpersonal skills with the ability to establish highly functional relationships with diverse personalities both within and outside the company.
- Demonstrated ability to manage multiple activities while maintaining a high level of organization
- Demonstrates initiative; ability to undertake additional responsibilities and respond to situation as they arise with little or no supervision.
- Experienced in Microsoft Office Suite