Senior Specialist, Engineering

Job Description

New hires based in the US & Puerto Rico will be required to demonstrate that they have been fully vaccinated for COVID-19 or qualify for a medical or religious exemption or accommodation to this vaccination requirement, subject to applicable law.

Our Company 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.

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

• 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

Education Requirements

• Bachelor Degree in Mechanical Engineering or equivalent technical major, or equivalent military training with related experience

Experience and Skills

Required

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

• Four years’ in industrial manufacturing, maintenance, industrial engineering and/or reliability engineering

• Strong and effective Program Management

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

• Strong mechanical aptitude

• Principled and strong communication and interpersonal skills

Preferred

• Demonstrated project management

• 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 years’ 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

Our Manufacturing & Supply Division is dedicated to being the most trusted supplier of biopharmaceuticals worldwide. Our facilities, along with our external contractors, suppliers, and partners, create a reliable global manufacturing network that’s devoted to delivering a high-quality, reliable supply to customers and patients on time, every time.

Who we are …

We are known as Merck & Co., Inc., Kenilworth, New Jersey, USA in the United States and Canada and MSD everywhere else. For more than a century, we have been inventing for life, bringing forward medicines and vaccines for many of the world's most challenging diseases. Today, our company continues to be at the forefront of research to deliver innovative health solutions and advance the prevention and treatment of diseases that threaten people and animals around the world.

What we look for …

Imagine getting up in the morning for a job as important as helping to save and improve lives around the world. Here, you have that opportunity. You can put your empathy, creativity, digital mastery, or scientific genius to work in collaboration with a diverse group of colleagues who pursue and bring hope to countless people who are battling some of the most challenging diseases of our time. Our team is constantly evolving, so if you are among the intellectually curious, join us—and start making your impact today.

NOTICE FOR INTERNAL APPLICANTS

In accordance with Managers' Policy - Job Posting and Employee Placement, all employees subject to this policy are required to have a minimum of twelve (12) months of service in current position prior to applying for open positions.

If you have been offered a separation benefits package, but have not yet reached your separation date and are offered a position within the salary and geographical parameters as set forth in the Summary Plan Description (SPD) of your separation package, then you are no longer eligible for your separation benefits package. To discuss in more detail, please contact your HRBP or Talent Acquisition Advisor.

Residents of Colorado

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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. Please click here if you need an accommodation during the application or hiring process.

For more information about personal rights under Equal Employment Opportunity, 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. We are an equal opportunity employer, committed to fostering an inclusive and diverse workplace.

Search Firm Representatives Please Read Carefully
Merck & Co., Inc., Kenilworth, NJ, USA, also known as Merck Sharp & Dohme Corp., Kenilworth, 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:R151090