Senior Specialist, Engineering (Utilities)

Job Description

The Senior Specialist, Engineer is a member of the Engineering team providing technical assistance within a capital project start-up in Durham, North Carolina. The new facility will include end-to-end processing of drug substance, drug product, including biotech culture growth, harvest, lyophilization, product inspection, utilities, and warehouse.

The candidate will be involved with the installation, operation, maintenance and/or troubleshooting of biopharmaceutical clean utility equipment and systems (WFI, Clean Steam, HVAC, and CDA), utility equipment and systems (Boilers, Chillers, etc).

The candidate will also work with manufacturing equipment such as washers, autoclaves, tanks, bioreactors, filtration skids, filling lines, lyophilizers and isolators. Develops Standard Operating Procedures (SOPs) and Preventative Maintenance (PM) plans as necessary. Is accountable for SAP transactions, validation testing, assisting root cause investigations and change control activities. Actively participates and embraces an inclusive team culture including significant interaction with operations, quality, automation, technology, and other groups.

Key Duties:

• Individual contributor role working with Staff and Technician employees and/or contractors.

• Decisions are guided by policies, procedures and business plan; receives guidance from manager.

• Contributes to the performance and results of the department.

• Manages small projects for equipment/maintenance-related improvements, including obtaining quotes, drawing/specification review/approval, and review of contracts

• Interact with vendors and assists with project coordination activities like design reviews, and engineering assessments

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

• Accountable for assisting in the identification, development, and implementation of new systems which enhances the operation and/or engineering processes.

• Assist with trouble shooting of utility equipment on an as needed basis which includes but not limited to:

• Utility Equipment (e.g. boilers, chillers, Cooling towers air compressors, waste deactivation systems)

• Clean Utility Equipment (e.g. HVAC, Clean steam generators, Water-For-Injection generation/distribution, reverse osmosis skids, compressed gas systems)

• Automated Systems (e.g. Distributed Control System (DCS), Programmable Logic Controllers (PLC))

• Clean-In-Place (CIP) Systems

  • Adapts and implements departmental plans and priorities based on division scorecard to address local business, service and operational challenges

  • Consults on an as-needed basis with next-level manager for newly identified priorities

  • Develops operating strategy from an Engineering / Maintenance perspective assisting with site reliability initiatives

Process Execution / Continuous Improvement:

• Oversee improvement projects and implementation of productivity enhancement initiatives.

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

• Anticipates and interprets client and/or customer needs to identify solutions

• The successful candidate must have strong problem-solving skills and a hands-on approach to problem solving.

Quality & Safety Compliance:

• Must be fully aware of requirement specifications from a qualification perspective (IC/OC, IQ/OQ, CRs, etc.)

• 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 identify root cause.

• Provide input to investigate deviations (both minor and major), with responsibility to interface with Operations, Maintenance, Automation, and Quality approvers.

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

• Actively assists with safety initiatives, including shop floor audits, lockout/tagout and Hazardous Energy Control Procedure updates

Communication:

• Works as a liaison between Engineering, Maintenance, Production and other Site Business Partner’s

• Participate in daily meetings to facilitate flow of information up/down through the organization

• Escalate issues as needed to ensure the right support/awareness is given to issues as they arise

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

• Serve as a Subject Matter Expert during tours to provide area/process overview information to visitors/auditors upon request

Financial:

• Ensure inventory transactions are complete, timely, and accurate

• Recognize and communicate opportunities for cost savings

Education Minimum Requirement:

• Bachelor Degree in Engineering, Science and 5 years experience or a Master’s Degree in Engineering, Science and 3 years experience in a production and/or calibration and/or maintenance background

Required Experience and Skills:

• Experience with regulatory requirements in accordance with GMP manufacturing operations

• Good oral and written communication skills

• Installation, operation, maintenance and/or troubleshooting experience with biopharmaceutical clean utility equipment

Preferred Experience and Skills:

• Project management, including change control and equipment qualification

• SAP experience related to plant maintenance and spare parts procurement systems

• cGMP experience in a sterile, bulk or finished pharmaceutical environment

• Experience authoring PM/calibration job plans and management of spare parts

• Mechanical functionality and reliability knowledge (asset management)

• Green Belt/Black Belt Certification

• Microsoft Project experience or similar platform.

Our Manufacturing & Supply Division is dedicated to being the most trusted supplier of bio-pharmaceuticals 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.

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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.

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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:

VISA Sponsorship:

Travel Requirements:

Flexible Work Arrangements:

Shift:

Valid Driving License:

Hazardous Material(s):

Number of Openings:

Requisition ID:R128403