Job Description

Our Manufacturing Operations teams are the people that make our products. We work in the manufacturing plants with a “Safety First, Quality Always” mindset striving for continuous improvement. We work in the local plant connected to our global manufacturing network to ensure the highest quality of raw materials, intermediates and finished products.

Our Engineers support internal and external manufacturing operations remain operational, continuously improve and innovate. With our extensive range of facilities and environments, our Engineers have opportunities across many diverse areas including Biological, Chemical, Automation, Capital Projects, Maintenance, Safety, Process Development, Technical Services, Utilities and Validation.

Position Description:

The Senior Specialist, is a member of the Focus Factory Automation team responsible for the assigned process control systems in support of manufacturing operations located in Durham, NC.

This Individual will provide leadership as the senior automation engineer for an aseptic manufacturing facility. Responsible for problem resolution, implementation of process control, data collection techniques, and troubleshooting in compliance with SDLC, GMP, safety, and environmental regulations. Actively support, participate and embrace an empowered team culture including significant interaction with manufacturing, quality and engineering groups. Supports a large spectrum of sophisticated automated systems within Manufacturing Operations; providing multiple opportunities to learn new automation technologies and make a positive impact. Provides direct support to Automation Lead including leading cross functional teams and providing direct guidance to the Automation team. Also provides technical coverage on automated systems.

Responsibilities may include, but are not limited to:

• Technical leadership for the assigned area and system(s) to ensure a compliant, reliable supply of the product and on-time project execution. Provide production shop floor support as needed.

• Application of sound project management techniques to meet schedule, budget, benefit realization and other project objectives.

• Provide technical guidance/support including authoring or review and approval of system commissioning and qualification documents, change control, automation incidents, Quality Notifications (QNs), and other key automation-related processes

• Providing direct support for regulatory inspections and audits and other validation activities by serving as the subject matter expert

• Understands and supports all GMPs, safety, and environmental regulations. Periodically reviews automation documents, preventive maintenance, and SOPs to ensure compliance with GMP and safety.

• Assisting in the development and review and approval of department SOPs and other site GMP SOPs related to automation and digital activities and adheres to established quality standards

• Develops and supports corrective actions associated with automation related deviations/investigations

• Communicates periodically with immediate supervisor about status of area of responsibility.

• Support digital innovation initiatives on an as-needed basis.

• Initiate and lead collaboration within the Operations, Quality, and Technical organizations to resolve complex problems.

• Uses technical knowledge to assure the efficient operation of variety of automated processing and information technology systems. Leads in installing and placing new equipment into operations. Develops solutions for automation problems. Oversees investigations of automation anomalies to prevent recurrence.

• On-floor support of manufacturing activities and periodic 24 x 7 on-call support.

• Identify and implement process/equipment improvements and manufacturing efficiencies.

• Maintain technical documentation.

• Initiate and lead collaboration within the Operations, Quality and Technical organizations to resolve complex problems.

• Provides client services support for business area applications.

• Serves as liaison with corporate and divisional automation and IT groups.

Position Qualifications:

Education Minimum Requirement:

• Bachelor’s degree or higher in Engineering or Computer Science

Required Experience and Skills:

• Minimum five (5) years of experience in a production regulated industry

• Minimum of five (5) years of experience in a GMP manufacturing automation-related role and direct experience with SDLC and change controls

• Direct experience with at least two of the three platforms 1) Emerson DeltaV 2), Allen Bradley PLC (or equivalent), and 3) PI (or equivalent)

• Demonstrated ability to build relationships with team, peers and area leads

• Demonstrated leadership in achieving shared objectives in a matrix organization

• Strong understanding of manufacturing principles/ processes and ability to translate manufacturing requirements into Automation/digital solution

• Proven track record of analytical skills, problem solving and attention to detail

• Able to demonstrate the our companies Leadership Principles and Enterprise Leadership

• High personal integrity, credibility, and energy

• Excellent communication and influencing skills

• Strong written and verbal communication skills in English

Preferred Experience and Skills:

• Data Integrity Acumen

• Lean Manufacturing /Six Sigma methodology.

Required Skills:

Audit Management, Automated Manufacturing Systems, Automation, Business Process Improvements, Communication, Data Collection Methods, Data Integrity, Data Management, Environmental Regulations, Environment Health and Safety, GMP Compliance, Management Process, Manufacturing Processes, Problem Management, Production Support, Quality Management, Real-Time Programming, Regulatory Inspections, Software Development Life Cycle (SDLC), Technical Leadership, Technical Writing Documentation, Veterinary Medicine

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:

10%

Flexible Work Arrangements:

Hybrid

Shift:

Not Indicated

Valid Driving License:

No

Hazardous Material(s):

n/a

Job Posting End Date:

10/7/2025

*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.