Specialist

About

Seeking candidates for a Specialist position within our company's research laboratories Biologics Pilot Plant (BPP) Equipment Engineering Team. This person will perform various activities regarding equipment maintenance and engineering supporting pilot-scale campaigns for the Good Manufacturing Practice (GMP) manufacture of bulk vaccine clinical supplies.

Responsibilities

• Providing maintenance staff with support for all scheduled work associated with designated equipment
• Scheduling equipment calibrations and preventative maintenance
• Conducting equipment Lock Out / Tag Out
• Managing qualified equipment inventories
• Supporting equipment validation activities
• Authoring, reviewing, and approving change management documentation
• Providing engineering guidance for equipment upsets and events
• Ensuring GMP status of equipment and facilities
• Conducting Equipment Qualification Periodic Review for designated equipment
• Creating equipment and facility work notifications for corrective maintenance
• Maintaining/managing equipment parts lists for designated equipment, ordering special parts when needed
• Managing small parts/accessories for equipment
• Leading small capital projects
• Evaluating new technologies and equipment for potential use in the area
• Supporting environmental and safety initiatives

Education Minimum Requirement

• Bachelor's degree in Engineering with minimum 3 years of relevant experience OR
• Master's degree in Engineering
• Candidates with a degree in a non-technical discipline plus relevant experience in pharmaceutical/biologics equipment management will be considered in lieu of a formal engineering degree

Required Experience And Skills

• Previous experience supporting equipment and/or GMP manufacturing facilities, or laboratory areas
• Strong teamwork and collaboration
• Extensive knowledge of cGMP, Quality Systems, and equipment safety
• Highly self-motivated with the ability to work in a fast-paced and dynamic setting

Preferred Experience And Skills

• Excellent organizational, problem-solving, and project management skills
• Strong technical background on pharmaceutical production equipment
• Experience working on teams in a matrixed organization

Required Skills

Adaptability, Analytical Instrumentation, Asset Inventory Management, Automation Systems, Bioprocessing, Calibration Management Software, Capital Projects, cGMP Compliance, Change Control Processes, Computerized Maintenance Management Systems (CMMS), Data Analysis, Electrical Systems, Environmental Health And Safety, Equipment Maintenance, GMP Compliance, Maintenance Processes, Maintenance Supervision, Manufacturing, Mechanical Handling, Mechanical Systems, Process Control, Regulatory Compliance, Small Business Management

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, 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 facility-based, manufacturing-based, or research-based positions where the work is located at a Company site.

Salary

The salary range for this role is $87,300.00 - $137,400.00. An employee's position within the salary range will be based on factors including education, qualifications, experience, skills, location, and business needs. The successful candidate will be eligible for annual bonus and long-term incentive, if applicable.

Benefits

We offer a comprehensive package of benefits including 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.

Additional Information

• US and Puerto Rico Residents Only
• No relocation
• Visa Sponsorship: No
• Travel Requirements: 10%
• Employee Status: Regular
• Job Posting End Date: 04/24/2026

Equal Opportunity

Our company is an Equal Employment Opportunity Employer committed to inclusion and prohibits discrimination on legally protected characteristics.

Application

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).