Equipment Technician II
South San Francisco, CA 94080 | Contract
Bayside Solutions is seeking an Equipment Technician II to be part of our client’ s team in South San Francisco. Imagine yourself collaborating with an organization focusing on the discovery, development, manufacturing, and commercialization of medicines to treat patients with severe or life-threatening medical conditions.
Our Company Bio: Founded in 2001, Bayside Solutions is 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.
Equipment Technician 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:
- Responsible for EQ in gASAT, which include end-to-end process of equipment qualification, maintenance, inventory management, change record and documentation.
- Ensure compliance, data integrity and efficient EQ operation, develop and maintain business process.
- Join the cross-functional and cross-site QC automation effort and lead the automation instrument qualification and database management sub team.
- Serve as QC network expert for QC robot qualification and script/data management Representing gASAT in global data integrity team and EQ related CAPAmeetings or other compliance improvement effort.
- Plan, coordinate, execute and document qualification of gASAT equipment and associated software compliance with GMP requirement.
- Generate System Requirement Specifications, User Requirement Specifications, System Impact Assessments, and Component Function Criticality Assessments
- Perform Quality Risk Assessments Coordinate with various functions within gASAT for priority and timelines of equipment qualification Write IQ/OQ/PQ protocols Execute IQ/OQ/PQ per protocols and write qualification reports Manage instruments inventory and PM schedule through SAP Set up an efficient system for performance maintenance tracking, scheduling and coordination Identify and propose resolution for validation deviations and discrepancies.
- Design and execute quality investigations and CAPA (corrective actions preventive actions) initiatives as needed Identify resolution to technical problems; lead troubleshooting in equipment qualification and calibration activities.
- Represent EQ function during internal and external audits and regulatory inspections. Responsible to addressing questions from audit inspection Ensure the EQ team meets schedules and timelines.
- Operate within the relevant quality computer systems e.g, SAP ensuring implementation in line with quality and timeliness objectives
- B.A. or B.S. degree (preferably in relevant scientific discipline) or an equivalent combination of education and experience and CAPA certifications.
- Candidate must have strong track record in successfully leading EQ function with limited direction EQ or operating experience with automatic QC robot such as Tecan or Hamilton is highly desirable.
- Previous hand on experience in analytical, cell based and PCR instruments and their qualification in GMP environment, and change control record is highly desirable.
- Excellent resource and task planning and prioritization skills with the ability to deliver high quality results per planned timelines.
- Knowledge of scientific theories, principles, techniques, used in analytical or biological/microbiologic test procedure.
- Knowledge of and experience with cGMP, compliance, and regulatory requirements for biopharmaceuticals are required.
- Experience with Labware LIMS, Trackwise, Change Control and other quality systems is desirable.
- Strong written and verbal communication skills with proven record in protocol, report and deviation/CAPA writing.
- Highly motivated and self-driven individual with the ability to work with minimal supervision to schedule, track, review, and report progress.
- Familiarity with GMP requirements and compliance, high attention to detail and good documentation practices.
- Consistently and independently exercises sound judgment, reasoning and problem solving.
- Capable of working under minimal supervision and determining own short term priorities.
- Basic knowledge of scientific theories, principles, techniques, used in analytical or biological/microbiologic test procedures.