Overview:
TekWissen is a global workforce management provider headquartered in Ann Arbor Michigan that offers strategic talent solutions to our clients world-wide. Our client is a leading biotechnology company that combines technological insight with world-class manufacturing scientific expertise and process excellence and helps their customers to deliver new and innovative medicines that help treat a wide range of diseases. Our client specializes in pharmaceutical ingredients Bioscience Biopharmaceuticals Custom manufacturing Biotechnology Life science ingredients Nutrition Microbial Control Agriculture Materials Science Personal Care and cell and gene therapy.
Job Title: Analytical Instrumentation Technician
Location: Vacaville CA - 95688
Duration: 4 Months
Job Type: Temporary Assignment
Work Type: Onsite
Shift: Monday to Friday from 08:00 AM to 05:00 PM
Job Description:
- In this role you will be primarily accountable for ensuring your assigned Process Analytical Technology (PAT) Systems deployed on the manufacturing floor are fit for purpose and ready for use by manufacturing.
- You will be responsible for performing routine maintenance on these systems including documenting completed maintenance activities using SAP.
- You will also be responsible for troubleshooting investigating and assessing unplanned equipment related events including communicating with the instrument vendors and escorting them to address issues on site when necessary improving reliability and implementing planned equipment changes.
- This temporary additional support is needed as the team ramps up to deploy numerous new PAT systems while supporting existing systems. At least 75% of the candidates time will be spent gowned into the GMP manufacturing space.
- The ideal candidate would have a technical understanding of and experience using cell counters and metabolite analyzers such as the Roche Cedex Bio Cedex HiRes and Cobas b 221 in either a GMP manufacturing or QC lab environment. Experience with other analytical equipment and devices is a plus such as the YSI 2900 Biochemistry Analyzer Nova BioProfile FLEX2 Advanced Instruments OsmoTech XT and Osmometer 3250 and EndressHauser Raman.
- They should also have a strong understanding of data integrity principles and experience using data management systems such as the Smartline Data Cockpit (SDC).
- The candidate will work with limited direction to complete assigned objectives to improve system uptime by preventing equipment failures.
- The candidate is not required to provide on-call after-hours support but that candidate would be considered for this depending on their qualifications availability and experience.
Required Qualifications:
- B.S is required (engineering or analytical science discipline preferred)
- Prior experience with analytical systems is preferred
- Sound knowledge of current Good Manufacturing Practices (cGMPs) as they apply to biopharmaceutical manufacturing facilities or equivalent regulation
- General knowledge of bio-tech related analytical methods and practices
- Experience with analytical systems data analysis and troubleshooting
- Knowledge of SAP system is a plus
- Must have excellent interpersonal communication and teamwork skills
- Strong verbal and written communication skills and the ability to influence at all levels
- Able to think strategically and translate strategies into actionable plans
- Takes responsibility drives results and achieves expected outcomes
- Uses extensive knowledge and experience to solve problems
- Performs work under limited supervision
- Develops strong productive relationships with users vendors and other relevant support groups.
- Proven ability to make sound decisions about scheduling allocation of resources and managing priorities.
- Position involves use of reagents and other chemical compounds including but not limited to acids bases corrosives biologic toxins microorganisms and potent compounds.
- Work with a wide variety of devices (or instruments).
- Calibrate troubleshoot repair and replace instruments as a part of the plants maintenance program.
- Maintain process instruments.
- Reduce cost of repairing equipment while maintaining or increasing the quality of repairs.
TekWissen Group is an equal opportunity employer supporting workforce diversity.