Description

Position Summary:

Oversees equipment and processes implemented from a microbiological standpoint.

• Determine appropriate sampling plans as needed during troubleshooting on both existing and R&D equipment/processes.
• Coordinate qualifications and troubleshooting activities on equipment in the Microbiology laboratory and document appropriately.
• Performs other duties as assigned or apparent.

Requirements

Primary Accountabilities

NOTE: The primary accountabilities and knowledge, skills and abilities listed below are intended to describe the general content of and requirements of this position and are not intended to be an exhaustive statement of duties. Incumbents may perform all or most of the primary accountabilities listed below. Specific tasks or responsibilities will be documented in the incumbents’ performance objectives as outlined by the incumbents’ immediate supervisor or manager.

• Assists other Microbiology Process Engineer(s) with instrument-related issues for internal staff and vendors.

• Assesses and coordinates Microbiology-related sampling and processes required for equipment throughout the Microbiology laboratory.

• Assists in the evaluation of media fill requirements for both existing and proposed equipment/processes, as needed.

• Participates in new equipment/processes discussions to evaluate from a microbiological standpoint.

• Performs administrative duties including documenting qualifications and validations to comply with regulatory requirements, cGMPs, SOPs, and logbooks.

• Performs assessments in Trackwise, as required.

• Plans, initiates, sets up, and performs routine maintenance, including installation qualifications (IQ), operational qualifications (OQ), performance qualifications (PQ), and preventive maintenance (PM) per internal procedures. 

• Provides expertise on equipment used in the Microbiology lab, as well as any modifications, updates, or new parts necessary to troubleshoot the equipment. 

• Works with QA to ensure compliance with cGMPs and internal SOPs for validation/qualification activities. 

• Provides or facilitate training to laboratory staff on existing and/or new equipment. 

• Creates or modify SOP’s, forms, logbooks, components, etc., as necessary, to facilitate the instrumentation program and operating procedures related to instrumentation and laboratory equipment.

• Ensures supplies are on hand to perform routine instrument maintenance, and ensures supplies for non-routine maintenance/troubleshooting are ordered promptly, as needed.

• Focuses on cost savings and value delivery, ensuring that instrument maintenance is of higher quality and lower cost than vendor maintenance contracts.

• Communicates Microbiology-related observations, issues, problems, discrepancies, and any violations of company policies or procedures to R&D Microbiology Manager, Assistant Director of Microbiology, Director of Microbiology, or designee. 

• Facilitates any laboratory support with IT, as needed, including 21 CFR compliance. 

Knowledge, Skills & Abilities:

• Master’s degree in Engineering or Bachelor’s degree and appropriate experience related to engineering and/or instrumentation.
• 2 – 5 years of experience with MS Word, Excel, and PowerPoint.
• Specific expertise, skills, and knowledge related to equipment throughout Nephron, including in the Microbiology laboratory gained through education and experience.
• Experience with cGMP documentation systems and with implementation of Quality Systems.
• Strong knowledge of FDA, USP, and industry requirements for analytical instrumentation qualification and maintenance. 
• The ability to set clear targets and use performance measures to assess risk and opportunities in order to effectively manage the assets of the business. 
• Must possess strong IT skills and a strong understanding of hardware and software troubleshooting of instrumentation.
• Must be detail oriented and have excellent organizational skills.
• The ability to manage a multitude of resources and to be accurate and current with data and information.
• The ability and willingness to change direction and focus to meet shifting organizational and business demands.
• A broad perspective that aligns decisions to organizational objectives and long-term consequences of day-to-day activities. 
• The ability to create and contribute environment that values people, encourages trust, teamwork, and open communication, and provides participation, learning, feedback and recognition.
• The ability to effectively manage one self, demonstrates integrity, be productive under pressure, and achieve development goals.
• Salary range: Based on experience
• Hours of Work: Monday through Friday, or as needed by department demand.