Job Description

Our company is a global health care leader with a diversified portfolio of prescription medicines, vaccines, and animal health products. The difference between potential and achievement lies in the spark that fuels innovation and inventiveness; this is the space where we have codified its legacy for over a century. Our success is backed by ethical integrity, forward momentum, and an inspiring mission to achieve new milestones in global healthcare.

Our Manufacturing Division is a team of dedicated, energetic individuals who are committed to being the most trusted supplier of pharmaceuticals and health products worldwide. Our facilities, along with our external contractors, suppliers, and partners, comprise an interdependent global manufacturing network that's committed to delivering a compliant, reliable supply to customers and patients on time, every time, across the globe.

As a member of the Engineering Maintenance & Utilities (EMU) Utilities Reliability Engineering Group, the primary role of the Utilities Reliability Engineer is responsibility for cGMP compliance and reliability for general utilities including compressed air, process compressed gases, chilled water, glycol, steam, potable water, and waste processing within our Manufacturing Division, including product manufacturing and laboratory facilities. With our extensive range of facilities and environments our engineers have opportunities across many diverse areas including Biological, Chemical, Automation, Capital Projects, Maintenance, Safety, Process Development, Technical Services, Utilities and Qualification/Validation.

This position is a support role for utility systems and will be involved with the utility systems cGMP compliance, troubleshooting, energy optimization and sustainability, system design, and application of the utilities reliability strategy. Long range capital planning, project management and project execution for related projects will also be required.

Job technical responsibilities include, but are not limited to:

Provides site wide governance with technical and engineering support as a Subject Matter Expert in the field for cGMP compressed air, process compressed gases and non-GMP building utility systems including chilled water, glycol, steam, potable water, waste processing, etc. The SME will ensure consistency and efficiency in compliance, operation, maintenance, system reliability, and sustainability.

Key Responsibilities Include:

• Establishes strategy documents for system design, operation, and maintenance.

• Performs reliability and business continuity assessments. Identifies areas for improvement, prioritizes action items, manages improvement projects, and demonstrates continuous improvement.

• Manages equipment obsolescence and capital improvement justifications. Reviews and approves capital project design, and supports commissioning and start-up activities ranging from documentation to equipment inspection.

• Optimizes equipment maintenance activities including preventive and predictive maintenance programs. Drives implementation of a consistent maintenance platform in alignment with ongoing initiatives.

• Supports the building utility RBAM process.

• Serves as liaison with site utility representatives for all utility work. Coordinates site utility projects with impacted buildings.

• Develops strong relationships with "system stakeholders" to ensure consensus on operational and regulatory compliance issues. Identify clear levels of ownership and accountability in support of respective systems.

• Supports complex troubleshooting with Engineering Maintenance & Utilities personnel. Interacts with hourly, salaried and contract employees in routine matters, troubleshooting equipment, automation systems.

• Drives root cause investigations, evaluates, develops, and improves business processes and develops technical rationale for system improvements. Eliminates repeat problems and reinvented solutions.

• Process lead for the Deviation Management associated with compressed gas systems.

• Interfaces and effectively speaks with regulatory agencies and supports agency inspections.

• Understands and communicates all applicable Divisional Standards/Guidelines, SOPs, and procedures governing the system operation and compliance. Ensures up-to-date record documentation, including drawings and qualification.

• Coordinates benchmarking and external analysis. Identify and share best practices and trends, communicate and drive improvement.

• Establishes business process baseline costs, identify key unit costs, and manages against the baseline.

• Energy Reduction and Sustainability - Identify and execute energy and sustainability projects in support for site goals.

• Serve as project engineer/technical liaison/capital team lead for capital projects to ensure reliability, maintainability, and operability of installed equipment, this includes interfacing with construction contractors to ensure scope execution and completion.

Qualifications

Education Minimum Requirement:

• Bachelor's Degree in Mechanical Engineering or equivalent technical major.

Required Experience and Skills:

• Four (4) years' experience in a functional area such as Operations, Technology, Engineering, Maintenance, Military and/or previous supervisory experience

• Four (4) years' expertise in industrial manufacturing, maintenance, industrial engineering and/or reliability engineering

• Strong Program Management experience

• Strong computer skills, including Microsoft Word, Excel, and PowerPoint

• Strong mechanical aptitude

• Strong communication and interpersonal skills

Preferred Experience and Skills:
Experience with utilities design, operation, and maintenance principles:

• Demonstrated project management experience

• Working knowledge of cGMP for pharmaceutical and/or vaccine manufacturing

• Certified Maintenance and Reliability professional (CMRP) or Reliability Centered Maintenance (RCM) Certification

• Computerized Management Maintenance Systems, SAP Plant Maintenance and/or ProCal

• Process Information (PI)

• Root Cause Analysis, Failure Mode Effects Analysis

• Two (2) years' experience in supporting relevant manufacturing or processing (aseptic/sterile, bulk, solid oral dosage, packaging, utilities etc.)

• Demonstrated knowledge of High Performing Organization tools and methodology, including Lean Six Sigma Methodology (Green Belt certification)

• Demonstrated experience of interacting with site, divisional or regulatory agencies

Your role at our company is integral to helping the world meet new breakthroughs that affect generations to come, and we're counting on your skills and inventiveness to help make meaningful contributions to global medical advancement. At our company, we're inventing for life.

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Our company is committed to inclusion, ensuring that candidates can engage in a hiring process that exhibits their true capabilities. Please click here if you need an accommodation during the application or hiring process.

We are an Equal Opportunity Employer, committed to fostering an inclusive and diverse workplace. All qualified applicants will receive consideration for employment without regard to race, color, age, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, or disability status, or other applicable legally protected characteristics. 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 diverse, talented, and committed people together. The fastest way to breakthrough innovation is when diverse ideas come together in an inclusive environment. We encourage our colleagues to respectfully challenge one another's thinking and approach problems collectively.

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U.S. Hybrid Work Model

Effective September 5, 2023, employees in office-based positions in the U.S. will be working a Hybrid work consisting of three total days on-site per week, Monday - Thursday, although the specific days may vary by site or organization, with Friday designated as a remote-working day, unless business critical tasks require an on-site presence.This Hybrid work model does not apply to, and daily in-person attendance is required for, field-based positions; facility-based, manufacturing-based, or research-based positions where the work to be performed is located at a Company site; positions covered by a collective-bargaining agreement (unless the agreement provides for hybrid work); or any other position for which the Company has determined the job requirements cannot be reasonably met working remotely. Please note, this Hybrid work model guidance also does not apply to roles that have been designated as "remote".

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:

Relocation:

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Requisition ID:R325134