Job Description

Join a premier research‑intensive biopharmaceutical organization at the forefront of delivering innovative health solutions. As a Sr Mechanical Engineer - Project Management, you will lead the engineering lifecycle for capital and improvement projects in a highly regulated environment, combining deep mechanical engineering expertise with rigorous project, portfolio, and stakeholder management. You will drive projects from concept through commissioning/qualification, ensure safety and quality compliance, optimize cost and schedule, and enable cross-functional teams to deliver reliable, efficient, and compliant operations.

Key responsibilities Mechanical engineering and technical leadership

• Own mechanical scope for projects across utilities, process equipment, facilities, and packaging/HVAC systems; develop URS/FRS/DDS and review provider deliverables

• Read and interpret engineering drawings, P&IDs, schematics, equipment manuals; perform and/or oversee design reviews (constructability, maintainability, ergonomics)

• Specify, evaluate, and select equipment; participate in FAT/SAT, punchlist resolution, and turnover to operations/maintenance

• Lead or manage development and execution of Commissioning, Qualification, and Validation (CQV) protocols for system changes and upgrades

• Ensure mechanical integrity and reliability; apply root-cause analysis and corrective/preventive actions across safety, compliance, automation, equipment, process, and people dimensions

• Develop and update SOPs and Energy Control Procedures, train end users on system interfaces and applications

Project management and delivery

• Define project scopes, deliverables, success criteria, and intake documents; align with Global/Site Engineering, EHS, Quality, and Operations

• Build and manage integrated schedules (e.g., MS Project) and stage-gates from concept through closeout; lead cross-functional project team meetings

• Develop cost estimates, budgets, and forecasts; track performance, risks, and changes; issue POs/change orders and verify/approve supplier invoicing

• Manage vendors, contractors, and consultants; ensure use of Job Safety Assessments during construction and at turnover

• Open and track Quality Change Requests and Safety Management of Change (MOC); coordinate Process Hazard Analyses and execution of action plans

• Conduct ergonomic, industrial hygiene, and other safety-related assessments and drive resulting action plans

• Close out projects, ensure asset capitalization, and assign depreciation profiles with Accounting/Finance

PMO, governance, and portfolio enablement

• Establish and apply project governance frameworks, policies, and standardized processes; drive reuse of lessons learned and knowledge management

• Centralize and communicate critical project information; deliver timely updates to stakeholders and senior leadership to support decisions

• Plan and schedule resources across the portfolio; conduct divisional portfolio and KPI reviews to optimize throughput and compliance

• Mentor and coach project managers/engineers; facilitate key team meetings, resolve conflicts, and enhance cross-functional team dynamics

• Analyze financials (budgets, risks, resource allocation) and provide financial reports and budget outlines to leadership

• Maintain schedules and critical data in enterprise project management systems; support change management and communications plans

Compliance, safety, and quality

• Ensure adherence to cGMP, OSHA/EHS, and applicable regulatory/industry standards for pharmaceutical/USDA-regulated environments

• Lead or support audits/inspections related to engineering changes, equipment, and facilities

• Champion Lean/Six Sigma and continuous improvement to enhance safety, quality, reliability, and energy efficiency

Qualifications Required

• Bachelor’s degree in Mechanical Engineering (or closely related engineering discipline)

• 5–10+ years of experience delivering mechanical engineering projects in highly regulated industries (biotech, pharma, food, nuclear, or energy), including end-to-end project management of $250K–$10M projects

• Demonstrated ability to develop engineering specifications (URS/FRS/DDS), read/interpret drawings and P&IDs, and lead FAT/SAT and CQV activities

• Proven experience establishing and managing schedules, budgets, risk registers, and change control; proficiency with MS Project and office productivity tools

• Strong problem solving and root-cause analysis across safety, compliance, automation, equipment, and process domains

• Excellent communication, leadership, stakeholder management, and team facilitation skills; ability to influence across functions and levels

• Working knowledge of regulatory/industry requirements for tightly regulated environments; familiarity with quality change control and MOC

• Ability to work in manufacturing environments with exposure to temperature extremes, noise, moving mechanical parts, and production chemicals

Preferred

• Experience in USDA-regulated and/or pharmaceutical manufacturing sites and capabilities

• PMP (Project Management Professional) or equivalent project management certification

• Lean/Six Sigma training or certification

• Experience with SAP or similar CMMS/ERP for parts, maintenance history, and asset data

• Working knowledge of end-to-end supply chain processes and their impact on engineering projects

• Advanced English; strong presentation skills and business acumen

Required Skills:

Capital Project Management, Change Management, Equipment Qualification, Facilities Engineering, Mechanical Engineering, Pharmaceutical Manufacturing, Project Team Leadership, Troubleshooting

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:

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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

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:

10%

Flexible Work Arrangements:

Not Applicable

Shift:

1st - Day

Valid Driving License:

Yes

Hazardous Material(s):

Yes

Job Posting End Date:

12/5/2025

*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:R374024