Senior Mechanical Services Engineer (Utilities)

Biopharma Careers; United States; On-site; USD 117,000 - 184,000; Full time

Job summary

Merck & Co. is seeking a Senior Mechanical Services Engineer to ensure reliable equipment performance through hands-on maintenance, troubleshooting, and investigations.

You will align projects with Safety, Compliance and Cost objectives and improve uptime with minimal supervision. The role requires a bachelor’s degree in engineering or science, at least five years in production or maintenance, and strong knowledge of GMP and calibration databases.

Qualifications

• Bachelor’s degree or higher in Engineering, Science, or related field.
• Minimum five years’ experience in production, calibration, or maintenance.
• Strong planning, scheduling, and time management skills.
• Knowledge of GMP regulatory requirements and documentation.
• Experience with calibration/maintenance databases and change control.

Responsibilities

• Analyze calibration, maintenance, and equipment performance and identify trends to reduce reactive work.
• Update calibration/maintenance SOPs to ensure safety and GMP compliance.
• Collaborate with Operations, Technology, Automation, and Quality to define investigations and root cause.
• Lead deviations investigations and ensure timely, well-documented closure.
• Drive process improvements to improve uptime and reduce costs.
• Develop training material and act as SME for system maintenance.
• Support safety programs and environmental compliance from a maintenance perspective.
• Collaborate with maintenance staff to sustain production equipment.
• Work with Reliability Engineers on RBAM assessments and action items.

Skills

Adaptability

Change Control Processes

Customer-Oriented

Deviation Management

Engineering Standards

GMP

Maintenance Engineering

Process Validation

Process Optimization

Regulatory Compliance

Root Cause Analysis (RCA)

Strategic Thinking

Teamwork

Technical Support

Technical Transfer

Education

Bachelor’s Degree or higher in Engineering, Science, or related field

Tools

GMP databases

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.

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

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

Qualifications

• Required: Bachelor’s Degree or higher in Engineering, Science, or related field
• Required: Minimum of five (5) years’ experience in a production and/or calibration and/or maintenance background
• Required: Strong planning, scheduling, and time management skills
• Required: Working knowledge of regulatory requirements in accordance with GMP manufacturing operations
• Required: Good oral and written communication skills
• Required: Experience with GMP compliant calibration and maintenance databases
• Required: Project management experience including change control and equipment qualification
• Preferred: cGMP experience in a sterile, bulk, or finished pharmaceutical environment
• Preferred: Experience with formal problem-solving techniques, such as root cause analysis (RCA), failure mode effects analysis (FMEA), and/or Lean Six Sigma tools
• Preferred: Experience in automation and manufacturing execution system (MES), process modeling, and process improvement
• Preferred: Experience in deviation management, troubleshooting, and resolving manufacturing anomalies
• Preferred: 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.

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:

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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

This is the lowest to highest salary we in good faith believe we would pay for this role at the time of this posting. An employee’s position within the salary range will be based on several factors including, but not limited to relevant education, qualifications, certifications, experience, skills, geographic location, government requirements, and business or organizational needs.

The successful candidate will be eligible for annual bonus and long-term incentive, if applicable.

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

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