Specialist, Operations (Night Shift)

1000 Merck Sharp & Dohme LLC; North Carolina; On-site; USD 79,000 - 125,000; Full time

Job summary

MSD in Durham, NC is seeking an Operations Specialist for a 3rd shift on a rotating 2-2-3 schedule. The role focuses on shop floor execution, batch closeout, and troubleshooting to improve department performance within a GMP environment.

Responsibilities include SOP authoring, batch/eLog review, safety investigations, CAPA coordination, and cross-functional collaboration with operations leaders. Requires strong communication and ability to mentor new staff.

Qualifications

• GMP experience required.
• Strong written and verbal communication skills.
• Ability to foster a collaborative work environment.
• Flexible and able to manage multiple priorities.
• Experience with SOPs and batch records.

Responsibilities

• Partner with operations management to implement production strategies and drives continual improvement.
• Author SOPs and perform document reviews.
• Batch Record Review and eLog Review.
• Lead safety investigations and CAPA activities.
• Lead problem-solving initiatives on the shop floor.
• Troubleshoot equipment and processes on shift.
• Coordinate with on-shift Operations Coaches (M1).
• Lead implementation of MPS principles on the shop floor.

Skills

Batch Record Review

CAPA Management

GMP Compliance

Data Analysis

Process Troubleshooting

Production Planning

Project Management

Regulatory Compliance

Team Leadership

Lean Manufacturing

Education

High School Diploma

Bachelor's in Technical Field

Tools

SAP

Job description

Job Description

The role as an Operations Specialist will be an energetic individual with strong interpersonal, leadership, and collaboration skills responsible for supporting shop floor execution, batch closeout, and general troubleshooting. This role will contribute directly to the overall performance and results of the VMF 102 department. This position is on-site and is a rotating 12-hour shift on night shift following the 2-2-3 schedule.

Responsibilities

• Partnering with the Operations management team to create and execute strategies that support design, development, delivery and evaluation of projects related to steady-state production and/or continual process improvement.
• Authoring and reviewing documents and SOPs.
• Batch Record Review eLog Review
• Lead safety investigations
• Lead Problem Solving initiatives
• Equipment and process troubleshooting
• Supporting on-shift Operations Coaches (M1)
• Author deviations and works to coordinate, develop and implement Corrective Actions/Preventive Actions (CAPAs)
• Lead implementation of MPS principles on the shop floor
• Sample management
• Ability to effectively support, upskill and mentor new employees
• Analyzing and implementing initiatives that will help to increase overall success within the department.
• Effectively using metrics and measurement to ensure that projects and initiatives result in desired outcomes.
• Ability to prioritize workload under guidance from management.

Education

Minimum Requirement: High School Diploma AND at least Five (5) years in a manufacturing, technical, support, or Military role. OR Bachelor’s degree in a technical field AND at least Three (3) years in a manufacturing, technical, support, or Military role. Bachelor’s degree and at least One (1) year of experience in a direct GMP, biotechnology, manufacturing setting.

Required Experience and Skills

• Experience working in a GMP environment
• Demonstrated written and verbal communications skills
• Ability to foster a collaborative work environment
• Demonstrated interpersonal, technical aptitude, and problem-solving skills
• Strong team skills, including the ability to coach/develop work teams, provide training, motivate/empower others, and resolve conflict
• Must be flexible and able to manage multiple priorities

Preferred Experience and Skills

• Understanding of MPS methodologies
• Experience with shop-floor cGMP manufacturing and related systems (i.e. SAP)
• Familiarity with pharmaceutical regulatory requirements
• Project management and data analysis skill
• Technical writing experience
• Experience with facility, equipment and/or process start up activities in a cGMP environment
• Demonstrated ability to work independently
• Production planning / scheduling experience
• #MSJR
• #VetJobs
• #SWE2026

Required Skills

• Adaptability
• Adaptability
• Batch Record Review
• CAPA Management
• cGMP Compliance
• Column Chromatography
• Communication Sciences
• Computer Literacy
• Data Analysis
• Environmental Health and Safety (EHS) Management
• Equipment Set Up
• Good Manufacturing Practices (GMP)
• Lean Manufacturing Tools
• Mentoring StaffOperations Management
• Pharmaceutical Regulatory Compliance
• Prioritization
• Process Improvements
• Process Monitoring
• Process Optimization
• Process Troubleshooting
• Production Planning
• Project Management
• Regulatory Compliance
• Sample Management
• {+ 8 more}

Preferred Skills

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.

Equal Employment Opportunity

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.

Location

The primary location for this posting is: USA - North Carolina - Durham (Old Oxford)

Salary

Where required by law, the compensation range for this role is provided below. The salary range for the primary location of this role is: $79,200.00 - $124,700.00 This range reflects the Company's reasonable expectation of the base salary applicable to this role at the time of 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.

Benefits

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.

Additional Locations

Additional location(s): Please note the salary range above applies to the Primary Location of the position. Where a role has other listed locations, different compensation guidelines may apply. You may find the salary ranges for additional locations below. If the salary range is not listed for the location you are applying to, our Talent Acquisition team will provide further information to you relevant to your location.

Additional location(s) Compensation Information: 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.

Employee Status

Regular

Relocation

No relocation

VISA Sponsorship

No

Travel Requirements

10%

Flexible Work Arrangements

Not Applicable

Shift

3rd - Night

Valid Driving License

No

Hazardous Material(s)

N/A

Job Posting End Date

Job Posting End Date: 11/16/2026* 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.

Company Summary

Our company is a global health care leader with a diversified portfolio of prescription medicines, vaccines and animal health products. The difference between potential and achievement lies in the spark that fuels innovation and inventiveness; this is the space where we have codified our legacy for over a century. Our success is backed by ethical integrity, forward momentum, and an inspiring mission to achieve new milestones in global healthcare.