Description

Job Description

Are you looking for an exciting opportunity with a rapidly growing pharmaceutical manufacturer? If so, then this is the opportunity for you!

The Senior Specialist, Engineer is a member of the Engineering team providing technical support within a new therapeutic manufacturing facility located in Durham, North Carolina. The new facility includes end-to-end processing of drug substance, drug product, including biotech culture growth, harvest, lyophilization, product inspection, utilities, and warehouse.

The candidate will be responsible/support the reliability, operation, and maintenance of HVAC, and clean utility equipment and systems (WFI, Clean Steam, HVAC, and CDA), utility equipment and systems (Boilers, Chillers, etc) to ensure proper functionality of manufacturing equipment such as washers, autoclaves, filling line, lyophilizers and isolators. The successful candidate will also develop Standard Operating Procedures (SOPs), Preventative Maintenance (PM) plans as necessary and responsible for supporting root cause investigations and change control activities.

Key Duties:

• Responsible for the maintenance and reliability of Clean Utility Equipment (e.g. HVAC, Clean steam generators, Water-For-Injection generation/distribution, reverse osmosis skids, compressed gas systems)
• Leads deviation investigations for HEPA and HEPA system failures, ensuring events are well-investigated and well-documented, while meeting timing commitments
• Manages small projects for equipment/maintenance-related improvements, including obtaining quotes, drawing/specification review/approval, and review of contracts
• Interact with vendors and support project coordination activities like design reviews, and engineering assessments
• Identifies and resolves technical and operational problems; collaborates with peers to resolve problems that cross into inter-related units
• Responsible for assisting in the identification, development, and implementation of new systems which enhance the operation and/or engineering processes.
• 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 supporting site reliability initiatives

Process Execution / Continuous Improvement:

• Oversee improvement projects and implementation of productivity enhancement initiatives.
• 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
• 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 causes.
• 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 supports 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
• Support 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/purchase order transactions are complete, timely, and accurate
• Recognize and communicate opportunities for cost savings

Education Minimum Requirement:

• Bachelor Degree in Engineering, Science and 6 years experience or a Master's Degree in Engineering, Science and 4 years experience in a production and/or calibration and/or maintenance background

Preferred Experience and Skills:

• Proficient in PI Processbook, Siemens BAS, and DeltaV
• 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)

VETJOBS

Required Skills:
Adaptability, Adaptability, Deviation Investigations, Engineering Process, Facility Management, Failure Mode and Effects Analysis FMEA, HVAC Systems, Identifying Customer Needs, Interpersonal Relationships, Lean Six Sigma Tools, Lockout Tagout, Manufacturing Quality Control, Pharmaceutical Microbiology, Plant Maintenance, Process Improvement Projects, Productivity Improvements, Project Coordination, Project Management, Regulatory Compliance, Regulatory Inspections, Root Cause Analysis (RCA), Steam Generators, Strategic Thinking, System Maintenance, Technical Writing {+ 1 more}

Preferred Skills:

Current Employees apply HERE

Current Contingent Workers apply HERE

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.

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

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".

The salary range for this role is
$114,700.00 - $180,500.00

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.

You can apply for this role through https://jobs.merck.com/us/en (or via the Workday Jobs Hub if you are a current employee). The application deadline for this position is stated on this posting.

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:
No Travel Required

Flexible Work Arrangements:
Not Applicable

Shift:
1st - Day

Valid Driving License:
No

Hazardous Material(s):
n/a

Job Posting End Date:
11/28/2025
*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:R372934