Utility Operations Engineer

Utility Operations Engineer-PRO010596

Description

Merck is a global health care leader with a diversified portfolio of prescription medicines, vaccines and consumer health products, as well as animal health products. Today, we are building a new kind of healthcare company - one that is ready to help create a healthier future for all of us.

Our ability to excel depends on the integrity, knowledge, imagination, skill, diversity and teamwork of people like you. To this end, we strive to create an environment of mutual respect, encouragement and teamwork. As part of our global team, you'll have the opportunity to collaborate with talented and dedicated colleagues while developing and expanding your career.

The Utility Engineer is a member of the Plant Engineering team providing technical support to the Durham Site. The site includes an Energy Center, Vaccines Manufacturing Facilities B101 and B102, Varicella Bulk Facility B130, Quality Labs, and Maintenance and Material Storage Facility (MMSF). This support position will focus on investigation of utility system excursions, system improvements and optimizations. Specifically, this individual will lead the deviation investigation to determine root cause, develop corrective actions to prevent reoccurrence and assess the impact on operations. The incumbent will also be responsible for leading plant engineering's improvement projects and implementation of productivity enhancement initiatives.

Specific
DUTIES:

* Lead in the identification and implementation of process improvement projects, productivity initiatives and corrective actions while focusing on equipment uptime, minimizing cost and maintaining process consistency

* Investigate deviations (both minor and major), with responsibility to interface with Operations, GVTE (Global Vaccine Technology), Automation, and Quality approvers and author and manage the investigations to meet key timing commitments with well-investigated and well-documented deviation reports.

* Work with the Operations, Technology, Automation, and Quality Approvers to determine the scope of the investigation identifying the appropriate root cause, implement corrective actions, complete trending analysis, and determine product disposition.

* Foster a collaborative relationship with manufacturing floor personnel focused on high quality investigations, meaningful corrective actions, and reducing the deviation generation rate. Determine appropriate corrective actions to prevent reoccurrence of the deviation. Ensure corrective actions are effective and improve right first time (RFT).

* As part of the deviation management role, present and defend investigations during regulatory inspections, as required.

* Perform a thorough review of engineering records and related GMP documentation, identifying and resolving discrepancies in a timely manner, and implementing corrective actions to improve the execution/review process.

* Develop training material. Working as a subject matter expert (SME), provide necessary training for system maintenance.

* Work alongside operations and lean six sigma team members to develop reliable, consistent manufacturing processes that meet cGMP requirements.

* Knowledgeable of all utility systems regarding functionally of equipment and relied on as SME during regulatory discussions.

* Identifies and resolves technical and operational problems; collaborates with peers to resolve problems that cross into inter-related units

* The successful candidate must have strong problem solving skills and a hands-on approach to problem solving. The successful candidate should be able to examine an issue from diverse perspectives (safety, compliance, automation, equipment, process, and people) in order to best understand and indentify root cause.

* Responsible for assisting in the identification, development, and implementation of new systems which enhances the operation of Plant Engineering processes.

* Assist with troubleshooting Plant Engineering equipment on an as needed basis which includes but limited to chillers, boiler, AHUs, PLCs, humidifiers/dehumidifies, water systems, Square D controllers/monitors, clean steam generators.

* Perform engineering task as needed to maintain plant utilities equipment.

Qualifications

Required:

* Bachelor's Degree in Science or Engineering Field

* A minimum of two (2) years of experience working in an Industrial Setting

* Familiarity with cGMPs and vaccine regulatory requirements

* Experience in problem solving and troubleshooting

* Technical writing and deviation investigation experience

* Utility and HVAC system process improvement and optimization experience

Desired:

* Master's Degree in Science or Engineering Field

* cGMP experience in a sterile, bulk or finished pharmaceutical environment.

* Experience with formal problem solving techniques, such as root cause analysis (RCA), failure mode effects analysis (FMEA), and/or Lean Six Sigma tools.

* Experience in automation and manufacturing execution system (MES), process modeling and process improvement.

* Experience in deviation management, troubleshooting and resolving manufacturing anomalies.

* A minimum of three year supervisory or project management experience.

Our employees are the key to our company's success. We demonstrate our commitment to our employees by offering a competitive and valuable rewards program. Merck's benefits are designed to support the wide range of goals, needs and lifestyles of our employees, and many of the people that matter the most in their lives.

Search Firm Representatives - Please read carefully:

Merck is not accepting unsolicited assistance from search firms for this employment opportunity. Please, no phone calls or emails. All resumes ted by search firms to any employee at Merck via-email, the Internet or in any form and/or method without a valid written search agreement in place for this position will be deemed the sole property of Merck. No fee will be paid in the event the candidate is hired by Merck as a result of the referral or through other means.

Merck is an equal opportunity employer, M/F/D/V - proudly embracing diversity in all of its manifestations.
Former Military, Transitioning Service Members, National Guard & Reserves - We value your past and present service.

Job: Production/Maintenance

Job Title: Specialist

Primary Location: NA-US-NC-Durham

Employee Status: Regular

Number of Openings: 1