Validation Engineer II
1 Antibody Way Oceanside, CA 92056
Bayside Solutions is seeking a Validation Engineer II to be part of our client’ s team in Oceanside. 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.
Validation Engineer II
- 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:
- General Commissioning, Qualification and Validation (CQV).
- Oversight of Change Records, which includes CR generation through tracking CR closure. CR’ s are for automation, facilities, utilities and process.
- Prepare/ Author Qualification and Commissioning Protocols.
- Perform Testing, collects samples, analyzing test results, and prepares Commissioning and Qualification summary reports.
- Plan, perform and coordinate Installation Qualification (IQ), inclusive of test generation and execution.
- Peer Reviews Validation Protocols, Commissioning Test and Design documents.
- Provide technical assessment and validation review/ approval for engineering, process and standard operating procedure changes.
- Prepare Risk Management Reports documenting system risks, applicable remediation/ risk reduction and critical controls.
- Provide input and continuous improvement recommendations to commissioning / qualification protocols.
- Manage development of accurate completion of all commissioning and qualification documentation and Engineering TOPs to ensure that such documents are properly documented and complete.
- Incorporate commissioning protocol execution with process testing and debugging activities.
- Participate in FAT, and manage SAT executions.
- Accountable for Project-specific:
- Design Qualification
- System Impact Assessments (SIA’ s)
- Criticality Assessment (CA’ s)
- Risk Assessment (RA’ s)
- Requirements Trace Matrices (RTM’ s)
- Design Verification
- Commissioning and Commissioning Test documentation
- Instrument Calibration assessments
- Operational Qualification and Process Qualification 1 (process support systems) documentation creation, execution and summary reports
- Provide C&Q support and updates for:
- User Requirements Specifications (URS)
- Functional Specifications (FS)
- Automation Functional Requirements (AFR)
- Functional Batch Record Review (FBRR)
- Support validation planning and execution efforts.
- Ability to successfully resolve and close Punch List items
- Project closeout activities.
- Attend any project specific meetings as assigned.
- Any additional activities, deliverables requested by Project Manager (or his designee)
- Maintain all required training to ensure job responsibilities can be performed on a daily basis.
- Vigilant to safety and maintains a safe environment for all during performance of job responsibilities (i.e. Validation Field Execution).
Summary of Qualifications:
- BS degree in Life Science, Engineering, Biology, Biochemistry or equivalent.
3-6 years of direct GMP/ validation experience with increasing levels of responsibility for protocol generation, execution and planning of wide range of validation equipment and software.
- Experience with Emerson DeltaV, Emerson Syncade and Pi software preferred.
- Proficient/ thorough knowledge of validation of principles, manufacturing processes, quality systems, engineering design fundamentals, regulatory agency expectation and industry trends.
- Strong technical writing, verbal communication, interpersonal and problem solving skills.
- Ability to work independently.
- Strong computer skills and familiarity with Microsoft office suite programs.
- Excellent collaboration and ability to communicate information to a varied audience.
- Compliance to cGMP requirements.
- Demonstrate good record keeping practices and attention to detail.