Process Analytical Technology System Owner
1000 New Horizons Way Vacaville, CA 95688
Bayside Solutions is seeking a Process Analytical Technology System Owner to be part of our client’ s team in Vacaville. 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.
Process Analytical Technology System Owner
- 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:
- GMP Services conducts the delivery of expense/capital projects and issue resolution during routine operations. This includes delivery of new or modified systems, system analytics, troubleshooting, and resolution of issues during the design and build of new / modified systems, assessments of deviations during operations, and implementation of corrections. GMP Services supports manufacturing operations through field troubleshooting, process monitoring, development of process improvements, and implementation of capital and expense projects. As part of the Process Analytical Technology (PAT) implementation, we are looking for a motivated individual with the knowledge of analytical method validation, in-process control bio-analyzer technology (e.g. RAMAN spectroscopy, Cedex Bio-analysis), and associated analyzer IT interface with the existing automation system.
- Provide technical expertise of spectroscopy and titer/metabolite profile analyzers (RAMAN and Cedex-bio is preferred).
- Proficiency in analyzer qualification process, while providing support to Validation group.
- Ability to perform maintenance and calibration on analyzers due to segregation of duty requirements from the floor operators.
- Interact and support QC with respect to analytical methods transfers
- Ownership of method including testing method (for example method transfer from QC to MFG)
- Risk Document assessment and ownership (including environmental monitoring, cleaning, and analyzers)
- Provide technical expertise to generate Operational and Maintenance SOP implementation
- Facilitate facility fit/requirements to bring in new analyzers, establish EIN number, asset tag, SAP part number, MRO for consumables
- Understand IT solutions to mitigate DI gaps (e.g System Data Collection / Data Cockpit software for offline analyzer and SynTQ software for Raman)
- Management of access control and Password
- Create and update analyzer system start-up and shut-down procedures
- Provide quick response to the system issues and trouble-shooting while effectively managing incidents
- Design and implement analyzer IT and vendor hardware and software changes
- Effectively manage Change Controls, SOPs and Work Instructions, and other relevant GMP documentation
- Assist IT and Automation in data communication, data back-up, data recovery and archiving
Summary of Qualifications:
- Bachelor' s degree in Chemistry, Chemical/Bio-Chemical Engineering
- Minimum 7 years of experience with process analytics and analyzers in Bio-process industry
- Sound knowledge of current Good Manufacturing Practices (cGMPs) as they apply to biopharmaceutical manufacturing facilities or equivalent regulation
- Must have excellent interpersonal, communication, and teamwork skills
- Expertise in PAT implementation for Process Equipment systems
- Knowledge of spectroscopy and bio-assay analyzer instruments with experience in RAMAN and Cedex Bio preferred.
- Demonstrated capability to create, advance, and validate new analytical methods.
- Knowledge of IT and LIMS systems infrastructure and analytical IT hardware and software
- Proficiency in understanding Process and Process Controls logic documentation (e.g. P&IDs, Functional Specs).
- Strong verbal communication skills and problem solving skills
- Ability to work independently