Job Description

The Senior Specialist, Automation is a key member of the Focus Factory Automation team supporting manufacturing operations in Durham, NC. In this role, you will serve as the lead automation engineer for an aseptic manufacturing facility, ensuring the reliability, performance, and compliance of critical process control systems. Responsibilities include troubleshooting complex automation issues, implementing process control and data collection solutions, and supporting manufacturing operations while adhering to SDLC, GMP, safety, and environmental requirements.

This position works closely with Manufacturing, Quality, Engineering, and IT teams to support a wide range of automated systems across the facility. The role provides technical leadership through leading cross-functional initiatives, mentoring automation team members, supporting the Automation Lead, and serving as a subject matter expert for automation systems. It also offers the opportunity to drive continuous improvement, implement new technologies, and make a meaningful impact on manufacturing performance and product quality.

Responsibilities

• Provide technical leadership for the assigned area and system(s) to ensure a compliant, reliable supply of the product and on-time project execution.
• Offer production shop floor support as needed.
• Apply sound project management techniques to meet schedule, budget, benefit realization, and other project objectives.
• Provide technical guidance/support including authoring or reviewing and approving system commissioning and qualification documents, change control, automation incidents, Quality Notifications (QNs), and other key automation-related processes.
• Serve as the subject matter expert for regulatory inspections and audits and other validation activities.
• Ensure compliance with GMPs, safety, and environmental regulations by periodically reviewing automation documents, preventive maintenance, and SOPs.
• Assist in the development, review, and approval of department SOPs and other site GMP SOPs related to automation and digital activities.
• Develop and support corrective actions associated with automation-related deviations/investigations.
• Communicate periodically with immediate supervisor about the status of the 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.
• Use technical knowledge to assure the efficient operation of various automated processing and information technology systems.
• Lead in installing and placing new equipment into operations and develop solutions for automation problems.
• Oversee investigations of automation anomalies to prevent recurrence.
• Provide 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.
• Provide client services support for business area applications.
• Serve as liaison with corporate and divisional automation and IT groups.

Qualifications

Required

• Bachelor’s degree or higher in Engineering or Computer Science
• 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: Emerson DeltaV, Allen Bradley PLC (or equivalent), and 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 solutions
• Proven track record of analytical skills, problem-solving, and attention to detail
• Able to demonstrate our company's 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

• Data Integrity Acumen
• Lean Manufacturing /Six Sigma methodology

Required Skills:

Preferred Skills:

Current Employees apply

Current Contingent Workers apply

US and Puerto Rico Residents Only:

The salary range for this role is

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 .

You can apply for this role through (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:

Relocation:

VISA Sponsorship:

Travel Requirements:

Flexible Work Arrangements:

Shift:

Valid Driving License:

Hazardous Material(s):

Job Posting End Date:

*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.