Specialist, Operations (Night Shift)

Merck & Co.; Durham (NC); On-site; USD 79,000 - 125,000; Full time

Job summary

Merck & Co. in Durham, NC is seeking an Operations Specialist to support shop floor execution, batch closeout, and troubleshooting within a GMP environment.

The role emphasizes leadership, collaboration, and problem-solving on a rotating 12-hour night shift (2-2-3 schedule) on-site. Responsibilities include SOP authoring, CAPA development, safety investigations, and collaboration with Operations coaches to drive continual process improvement and production planning.

Qualifications

• GMP environment experience required or preferred.
• Demonstrated written and verbal communications skills.
• Ability to foster a collaborative work environment.
• Demonstrated interpersonal, technical aptitude, and problem-solving skills.

Responsibilities

• Support shop floor execution, batch closeout, and troubleshooting on the VMF 102 department.
• Lead safety investigations and CAPA implementation.
• Lead MPS principles on the shop floor and mentor new employees.
• Utilize metrics to ensure projects achieve desired outcomes and prioritize workload under management guidance.

Skills

Batch Record Review

CAPA Management

cGMP Compliance

Process Improvements

Project Management

Data Analysis

Production Planning

Team Leadership

Problem Solving

Education

High School Diploma

Bachelor's degree in a technical field

Bachelor's degree + GMP/biotech experience

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 may include but are not limited to;

• 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 Staff


• Operations 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:

• #MSJR #VetJobs #SWE2026


• 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 Staff


• Operations Management


• Pharmaceutical Regulatory Compliance


• Prioritization


• Process Improvements


• Process Monitoring


• Process Optimization


• Process Troubleshooting


• Production Planning


• Project Management


• Regulatory Compliance


• Sample Management


• {+ 8 more}

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 Resources

• 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.

Primary Location

USA - North Carolina - Durham (Old Oxford)

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

Benefits

• medical


• dental


• vision healthcare and other insurance benefits (for employee and family)


• retirement benefits, including 401(k)


• paid holidays


• vacation


• compassionate and sick days

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.

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:

11/16/2026

Posting Deadline Note

*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:

R424357