Senior Specialist, Manufacturing Automation

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 company in the United States and Canada, 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 our company has codified its legacy for over a century. Our company's success is backed by ethical integrity, forward momentum, and an inspiring mission to achieve new milestones in global healthcare. Our company Manufacturing Division is a team of dedicated, energetic individuals who are committed to being the most trusted supplier of pharmaceuticals and health products worldwide.

Our facilities, along with our external contractors, suppliers, and partners, comprise an interdependent global manufacturing network that’s committed to delivering a compliant, reliable supply to customers and patients on time, every time, across the globe.

Responsibilities include but not limited to the following:

• Direct/prioritize workload activities of a professional staff of 3 – 5 engineers to provide process automation support to enable the reliable and compliant supply of vaccines in our vial and syringe filling area.

• Possesses strong Distributed Control System(DCS) experience and has led mid to large projects involving automated systems such as DeltaV, PLC, BUS, OPC technologies.

• Knowledgeable of S88 Batch Standard desirable.

• The process automation team is responsible for the resolution of automation problems, implementation of process control, data collection techniques, and troubleshooting in compliance with System Development Life Cycle (SDLC), GMP, safety, and environmental regulations.

• Motivate staff in a manner that fosters an integrated team environment.

• Understands and supports all GMPs, safety, and environmental regulations.

• Responsible for ensuring automation documents, preventive maintenance, periodic reviews, and SOPs are in an inspection-ready state.

• Support process automation inquiries during internal and external audits/inspections, and must, therefore, be able to speak knowledgeably about automation, process and cGMP details of the manufacturing operations.

• Evaluates automated and information technology systems and develops strategies to optimize and ensure the quality and stability of automation systems through future expansion, replacement, or upgrade.

• Uses technical knowledge to assure the efficient operation of a 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 a recurrence. This includes on-floor support of manufacturing activities.

• Leads in the development of technical requirements, keeping in mind the associated technology needs, benefits, and risks.

• Analyzes complex business requirements using tools and techniques and identifies internal/external solutions to meet these requirements

• Lead in developing control strategies and apply computerized tools that will deliver tangible improvements to overall production unit performance.

• Communicates daily with the operation, technical, and quality representatives within the area of support through the tier process.

• Familiar with six-sigma and lean manufacturing principles with an ability to convert business logic and requirements into detailed system requirements.

• Able to analyze the process for an increase in capacity, efficiency, environmental protection, flexibility, quality, and yield and devise advanced solutions that directly achieve the desired results.

• Uses technical knowledge to assure the efficient operation of a variety of automated processing and information technology systems.

• Takes a lead role in installing and placing new equipment into operation. Develops solutions for automation problems.

• Oversees investigations of automation anomalies to prevent a recurrence.

• Design solutions to ensure the quality and stability of automation systems through future expansions, replacements, or upgrades.

• Leverages code structure and system architecture solutions from other factories, projects, and sites to ensure that automation systems are robust, efficient, and consistent with industry standards.

• Performs preventive maintenance, performance monitoring, and revises or develops automation Standard Operating Procedures to keep the system and the user operability in an optimal state.

• Lead complex software system testing and validation procedures and oversee system configuration and documentation.

• On the floor troubleshooting support of manufacturing activities

• Maintains accurate, unambiguous and meaningful automation system documentation in a secure but easily accessible manner.

• Provides training and serves as a technical resource for other engineers.

Education Requirements:

• A minimum a B.S degree in engineering, computer science/electrical/chemical/mechanical, or equivalent

• A minimum of 6 yrs experience in process automation or equivalent.

Required Skills:

• Candidate must possess a strong knowledge of business impacts and prioritization of technical initiatives and must demonstrate excellent interpersonal skills including flexibility and ability to work in a team environment.

• Candidate must be knowledgeable of cGMP’s, safety guidelines, engineering standards, and regulatory issues.

Employees working in roles that the Company determines require routine collaboration with external stakeholders, such as customer-facing commercial, or research-based roles, will be expected to comply not only with Company policy but also with policies established by such external stakeholders (for example, a requirement to be vaccinated against COVID-19 in order to access a facility or meet with stakeholders). Please understand that, as permitted by applicable law, if you have not been vaccinated against COVID-19 and an essential function of your job is to call on external stakeholders who require vaccination to enter their premises or engage in face-to-face meetings, then your employment may pose an undue burden to business operations, in which case you may not be offered employment, or your employment could be terminated. Please also note that, where permitted by applicable law, the Company reserves the right to require COVID-19 vaccinations for positions, such as in Global Employee Health, where the Company determines in its discretion that the nature of the role presents an increased risk of disease transmission.

Current Employees apply HERE

Current Contingent Workers apply HERE

US and Puerto Rico Residents Only:

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We are proud to be a company that embraces the value of bringing diverse, talented, and committed people together. The fastest way to breakthrough innovation is when diverse ideas come together in an inclusive environment. We encourage our colleagues to respectfully challenge one another’s thinking and approach problems collectively. We are an equal opportunity employer, committed to fostering an inclusive and diverse workplace.

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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):

Requisition ID:R237467