Senior Mechanical Services Engineer (Utilities)

Merck; Durham (NC); On-site; USD 117,000 - 184,000; Full time

Job summary

Merck & Co., Inc. in Durham, NC seeks a Senior Mechanical Services Engineer to ensure reliable equipment performance through hands-on maintenance, troubleshooting, and investigations, while aligning projects with Safety, GMP and cost objectives.

Required: a Bachelor’s degree or higher in Engineering or Science, at least five years in production, calibration, or maintenance, and strong planning, communication, and GMP knowledge. 1st shift with occasional off‑shift support.

Qualifications

• Bachelor’s degree or higher in Engineering, Science, or related field
• Five or more years of experience in production, calibration, or maintenance
• Strong planning, scheduling, and time management skills
• GMP regulatory knowledge and compliant practices
• Good oral and written communication skills
• Experience with GMP calibration/maintenance databases
• Project management including change control and equipment qualification

Responsibilities

• Analyze calibration, maintenance, and equipment performance and identify trends to reduce reactive work and increase reliability
• Identify revisions or additions to calibration/maintenance programs and SOPs to ensure safety, GMP, and calibration/maintenance procedures
• Collaborate with Operations, Technology, Automation, and Quality Approvers to determine scope of investigations and root cause
• Establish Safety guidelines and participate in divisional Safety Audit activities
• Lead deviation investigations for instruments, equipment, and system failures with timely documentation
• Lead process improvement projects focusing on uptime, cost reduction, and process consistency
• Develop training material and act as SME for system maintenance
• Work with Operations and Lean Six Sigma to develop reliable manufacturing processes meeting cGMP
• Support safety programs (LOTO, HECP) and environmental compliance
• Collaborate with maintenance technicians and engineers to maintain production equipment
• Work with Reliability Engineers on RBAM assessments and actions

Skills

Planning

Project management

Root Cause Analysis (RCA)

Regulatory compliance

Teamwork

Communication skills

Education

Bachelor’s degree or higher in Engineering or Science

Tools

Calibration/maintenance databases

Lean Six Sigma tools

MES / Manufacturing Execution System

Job description

Job Description

At our company, we aspire to be the premier research-intensive biopharmaceutical company. We're at the forefront of research to deliver innovative health solutions that advance the prevention and treatment of diseases in people and animals. We use the power of leading-edge science to save and improve lives around the world. Join our team and be part of a company that is making a difference.

The Senior Mechanical Services Engineer position will ensure the reliable performance of equipment by providing hands-on maintenance support for complex troubleshooting and repairs of equipment, as well as supporting Technology and Quality during equipment investigations and modifications. The successful candidate will be responsible for aligning maintenance projects with the business objectives around Safety, Compliance and Cost. The Senior Mechanical Services Engineer must be able to self-identify opportunities for improvement and execute with minimal supervision.

This position is a 1st shift position with the potential for infrequent off shift work as needed to support business results. This position is expected to work as an independent member of an integrated team focused on achieving the team’s objectives, vision, and goals.

Responsibilities

• Analyze calibration, maintenance, and equipment performance and work orders to identify trends with an emphasis on reducing reactive work and increasing reliability
• Identify revisions, deletions, or additions to the calibration and maintenance programs and Standard Operating Procedures (SOPs) to ensure that calibration and maintenance activities are completed in accordance with established safety, GMP, and calibration/maintenance procedures
• Work with Operations, Technology, Automation, and Quality Approvers to determine the breadth and scope of the investigation to identify the appropriate root cause, implement corrective actions, complete trending analysis, and determine product disposition
• Help establish processes that ensure required Safety guidelines are followed and participate in divisional Safety Audit activities
• Lead deviation investigations for instruments, equipment, and system failures, ensuring events are well-investigated and well-documented, while meeting timing commitments
• 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
• Develop training material and work as a subject matter expert (SME) to 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
• Support safety programs (LOTO, HECP, etc.) and environmental compliance from a maintenance perspective
• Collaborate with the production area maintenance technicians and engineers to maintain all production equipment
• Collaborate with the Technical CoE Reliability Engineers to conduct periodic RBAM assessments and own area-specific reliability actions

Qualifications

Required

• Bachelor’s Degree or higher in Engineering, Science, or related field
• Minimum of five (5) years’ experience in a production and/or calibration and/or maintenance background
• Strong planning, scheduling, and time management skills
• Working knowledge of regulatory requirements in accordance with GMP manufacturing operations
• Good oral and written communication skills
• Experience with GMP compliant calibration and maintenance databases
• Project management experience including change control and equipment qualification

Preferred

• 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
• Experience with Lyophilization and/or Filling Manufacturing Processes and equipment

Required Skills

Adaptability, Change Control Processes, Customer-Oriented, Deviation Management, Engineering Standards, Good Manufacturing Practices (GMP), Maintenance Engineering, Manufacturing Process Validation, Process Optimization, Regulatory Compliance, Root Cause Analysis (RCA), Strategic Thinking, Teamwork, Technical Support, Technical Transfer

US And Puerto Rico Residents Only

Our company is committed to inclusion, ensuring that candidates can engage in a hiring process that exhibits their true capabilities.

Requirements

As an Equal Employment Opportunity Employer, we provide equal opportunities to all employees and applicants for employment and prohibit discrimination on the basis of race, color, age, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, disability status, or other applicable legally protected characteristics. As a federal contractor, we comply with all affirmative action requirements for protected veterans and individuals with disabilities. For more information about personal rights under the U.S. Equal Opportunity Employment laws, visit:
EEOC Know Your Rights
EEOC GINA Supplement
We are proud to be a company that embraces the value of bringing together, talented, and committed people with diverse experiences, perspectives, skills and backgrounds. The fastest way to breakthrough innovation is when people with diverse ideas, broad experiences, backgrounds, and skills come together in an inclusive environment. We encourage our colleagues to respectfully challenge one another’s thinking and approach problems collectively.
Learn more about your rights, including under California, Colorado and other US State Acts

The salary range for this role is
$117,000.00 - $184,200.00

We offer a comprehensive package of benefits. Available benefits include medical, dental, vision healthcare and other insurance benefits (for employee and family), retirement benefits, including 401(k), paid holidays, vacation, and compassionate and sick days. More information about benefits is available at https://jobs.merck.com/us/en/compensation-and-benefits.

San Francisco Residents Only

We will consider qualified applicants with arrest and conviction records for employment in compliance with the San Francisco Fair Chance Ordinance

Los Angeles Residents Only

We will consider for employment all qualified applicants, including those with criminal histories, in a manner consistent with the requirements of applicable state and local laws, including the City of Los Angeles' Fair Chance Initiative for Hiring Ordinance

Search Firm Representatives Please Read Carefully

Merck & Co., Inc., Rahway, NJ, USA, also known as Merck Sharp & Dohme LLC, Rahway, NJ, USA, does not accept unsolicited assistance from search firms for employment opportunities. All CVs / resumes submitted by search firms to any employee at our company without a valid written search agreement in place for this position will be deemed the sole property of our company. No fee will be paid in the event a candidate is hired by our company as a result of an agency referral where no pre-existing agreement is in place. Where agency agreements are in place, introductions are position specific. Please, no phone calls or emails.

Employee Status

Regular

Relocation

No relocation

VISA Sponsorship

No

Travel Requirements

10%

Flexible Work Arrangements

Not Applicable

Shift

1st - Day

Valid Driving License

No

Hazardous Material(s)

n/a

Job Posting End Date

• A job posting is effective until 11:59:59PM on the day BEFORE the listed job posting end date. Please ensure you apply to a job posting no later than the day BEFORE the job posting end date.

Requisition ID

R414280