Job Description

Job Responsibilities:

• 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 candidate’s 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 Endress+Hauser 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.

Skills:

• 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 plant's maintenance program.
• Maintain process instruments.
• Reduce cost of repairing equipment while maintaining or increasing the quality of repairs.
• To further discuss this opportunity, please send us your updated MS Word formatted Résumé.

Education/Experience:

• Education and Industry Experience:
• B.S is required (engineering or analytical science discipline preferred)
• Prior experience with analytical systems is preferred

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