Facilities Engineer

3 days ago

Raleigh, North Carolina, United States Eliquent Life Sciences, Inc Full time

ELIQUENT Life Sciences is the leading global consulting firm providing solutions to life science companies researching, developing, and manufacturing innovative products to serve patients and respond to public health challenges around the world. ELIQUENT is committed to serving clients' needs with extensive expertise, unwavering integrity, and strategic insight in a manner that supports availability of safe, effective, and high-quality drugs, biologics, and medical devices. For more information, please visit our website at

The Facilities Engineer will provide technical leadership and expertise supporting production operations in the areas of reliability, design, maintenance, and cleaning of facilities, water, and micro. Assist with process optimization, equipment qualification, equipment capability studies, asset management, and metrology.

Key Deliverables:

Apply statistical thinking and use of data to monitor process performance and make engineering decisions based on first principles.Conduct root cause analysis for equipment and operational events and other technical documents.Support, develop and maintain the basis of safety for process equipment.Provide engineering support for Task Risk Assessments (TSAs) and Job Hazzard Analysis (JSAs).Review the basis for the qualification of the equipment and ensure that the equipment/system is appropriate for the intended purpose.Identify and implement continuous improvement opportunities related to equipment and processes as core member of cross-functional process team.Provide technical oversight of ongoing equipment qualification requirements.Provide technical oversight during development of equipment and process system User Requirements and related Design Review/Qualification documentation to ensure equipment and systems are appropriate for intended purpose.Provide guidance on key elements of return to service requirements for equipment after interventions such as maintenance.

Key Responsibilities:

Bachelor's Degree in Mechanical, Process, Chemical, Biochemical Engineering or related applicable discipline8+ years of experience in API and/or cGMP Filling/Packaging OperationsExperience in operating and maintaining utility equipment including, but not limited to: Boilers, Chillers, Air Compressors, WFI water systems, Clean Steam generators, Air Compressors, Air Handling Units, CIP skids, and Waste Neutralization.Experience in Aseptic operations, contamination control studies, and QC micro.

Qualifications:

Experience executing predictive and preventive maintenance on GMP and non-GMP utility equipment.Working knowledge of utility equipment from an operation and manufacturing impact perspective.Experience calibrating and repairing instrumentation associated with GMP utility and non GMP utility systems.Investigates, troubleshoots, and provides repairs to electrical systems, controls, motors, emergency generators, switchgear, variable frequency drives, substations and MCCs.Knowledgeable working with HVAC systems.Carries out all duties in compliance with all company, state and federal regulations and guidelines including FDA, EPA, and OSHA.Participate in Maintenance projects as required including but not limited to Root Cause Analysis, FMEA's, and Non- Conformance investigationsDemonstrates willingness to learn new skills as requiredStrong knowledge of regulatory requirements, industry standards, and best practices in cGMP.Excellent communication, leadership, and interpersonal skills to effectively manage cross-functional teams and liaise with clients.Strong analytical and problem-solving abilities to address complex challenges proactively.Comply with all company and/or site policies and proceduresExperience of Delta V, PLC and SCADA systems

BENEFITS:

What We Offer:

Competitive Compensation: Attractive salary and comprehensive benefits package for full-time and part-time employees, including health, dental, vision, and life insurance, a 401(k) plan with employer match, a generous paid time off policy, and additional perks. Compensation is commensurate with professional experience.

Career Development: Opportunities for professional growth and advancement within a supportive and innovative environment.

Work-Life Balance: Flexible work arrangements and a commitment to maintaining a healthy work-life balance.

Eliquent Life Sciences is proud to be an Equal Opportunity Employer, committed to employee diversity.

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