Senior Specialist, Manufacturing Automation (Shop Floor Platforms)

Job Description

New hires based in the US & Puerto Rico will be required to demonstrate that they have been fully vaccinated for COVID-19 or qualify for a medical or religious exemption or accommodation to this vaccination requirement, subject to applicable law.

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.

General:

Senior Specialist, Manufacturing Automation: Responsible for working both independently and as a part of a team to implement Automation and IT initiatives that will enable our Company to deploy consistent production manufacturing processes integrated with common global information systems. The individual will be a subject matter expert of serialization/aggregation (track and trace) systems (Systech Sentris, Systech Advisors and Systech Guardian systems) and serve as the site point of contact for SAP ATTP application as related to serialization activities. Leads key automation support for various manufacturing systems such as PLCs, HMIs and OEM systems in Manufacturing Operations. Develops strategies to optimize and ensure quality and stability of automation/IT systems through future expansion, replacement, or upgrade. Works with plant maintenance, engineering, operations and process improvement teams to address line performance issues and implement continuous improvement initiatives. This role will partner with site cross-functional teams and global support functions to ensure successful system functionality and operations. Conducts/supports quality investigations related to equipment/system malfunctions and leads corresponding corrective and preventive actions to on-time closure. Leads/supports qualification activities as well as associated GMP documentation and automation change controls. Fosters an inclusive environment and a safety culture while adhering to our Company code of conduct, values and competencies.

Functional Expertise:

This position requires knowledge and experience in own discipline while still acquiring higher-level knowledge and skills. The position will build knowledge of the company, processes, clients/customers and will solve a range of problems while providing possible solutions. This position may often work autonomously with a moderate level of guidance and direction. This position applies team effectiveness skills, listening and integrating diverse perspectives from across the work group; contributes and adds value to the achievement of team goals.

Responsibility:

The Senior Specialist, Manufacturing Automation (Shop Floor Platforms) position is responsible for the resolution of significant automation issues and maintenance of automation systems in compliance with cGMPs, SLC, safety, and environmental regulations. Provides guidance and expertise necessary to support systems related to the site’s serialization/aggregation (track and trace) processes. Provides guidance and support for new manufacturing information systems to the site including Manufacturing Execution System (MES), Electronic Batch Record (EBR), OSISoft PI historian, Rt Reports and supporting interfaces. Supports production automation systems as required. Responsible for resolution of significant automation issues and maintenance of automation systems in compliance with cGMPs, SLC, safety, and environmental regulations. Provides guidance on process control, data collection techniques, and failure mode and effects analysis. Oversees contract resources and vendors as required.

Primary activities include, but are not limited to:

The Senior Specialist, Manufacturing Automation (Shop floor Platforms) will be responsible for providing technical support and leadership to plant project teams, data management, interfaces to other systems, performance, growth analysis, contractor supervision, standards administration, documentation, continuity planning and design skills. The Senior Specialist is responsible for supporting the following as the discipline requires:

• Provides automation technical support for site implementation and on ongoing management of serialization/aggregation (track and trace) systems (Systech Sentris, Systech Advisors and Systech Guardian systems). Serves as the site point of contact for SAP ATTP application as related to serialization activities.

• Reviews and supports the configuration and architecture of automation systems to ensure the successful integration of process control systems, serialization systems, manufacturing execution systems, shop floor systems/equipment, and data historians.

• Provides on-floor support of manufacturing activities associated with manufacturing and packaging equipment and associated control systems (i.e. PLCs, HMIs, Vision Systems).

• Evaluates shop floor systems and develops optimization strategies and solutions that ensure quality, reliability, and scalability.

• Works with above-site IT support organizations (GTO, AMS, ITRMS, etc.) to communicate and minimize the impact of IT changes on shop floor activities. Manages the relationship between shop floor support organizations and the business to ensure a positive, productive experience.

• Manages project activities following approved business processes to deliver results that are quality engrained, right first time, on-time with schedule requirements, reconciled to the budget, and meeting all Quality requirements. Leads projects by engaging team members, setting clear expectations, utilizing strong communication skills and exercising clear decision-making. Regularly and clearly communicate project plans, risks and strategy to all key stakeholders, customers and governance committees.

• Understands and supports GMP, safety and environmental regulations and policies. Provides guidance to the Automation & IT team for appropriate procedures to ensure compliance with those policies as related to shop floor systems. Periodically reviews technical documents and GDLs/SOPs to ensure compliance with our Company guidelines and policies. Maintains shop floor systems in compliance with SLC, cGMPs, safety, and environmental regulations.

• Understands and supports our Company’s cybersecurity and data integrity policies and guidelines. Provides guidance to the Automation & IT team for appropriate procedures to ensure compliance with those policies as related to shop floor systems. Reviews technical documents to ensure compliance with our Company guidelines and policies. Maintains shop floor systems in compliance with security and data integrity guidelines and policies.

• Provides technical guidance/support including authoring, reviewing and approval of automation incidents, Quality Notifications (QNs), root cause analyses and other key automation related processes. Develops and supports quality investigations and corrective actions for shop floor systems to resolve complex problems and prevent reoccurrence.

• Authors/Maintains technical documentation (Project Plans, Master Specifications, Requirements, Qualifications, Change Controls, Standard Operating Procedures, etc).

• Assists in the development, review, and approval of department Standard Operating Procedures and other site Good Manufacturing Practice Standard Operating Procedures related to automation and shop floor systems.

• Participates in agency inspections, internal GMP & systems audits and training programs in the area of responsibility

• Collaborates with colleagues at our Company sites to discuss common issues and share best practices.

• Manages external contractors supporting operations or select project work as required. Sets clear expectations for work delivered and expected behaviors. Monitors performance and ensures contractual obligations are met.

• Occasionally works off-shift hours to support multi-shift operations and also to implement system solutions during windows of non-production.

Education Minimum Requirement

• B.S., B.A., or M.S. in Information Technology, Science, Engineering, or equivalent discipline.

Required Experience and Skills:

• Minimum of eight years’ experience in IT/Automation support of manufacturing, process engineering or equivalent operations.

• Working knowledge of Track and Trace serialization applications (Systech Guardian, Advisory, Sentri).

• Working knowledge of PLCs, HMIs, and Servo-Drives.

• Working knowledge of the regulatory requirements for pharmaceutical applications.

• Experience in computer validation and systems lifecycle development methodology.

• Experience authoring and reviewing standard operating procedures, on-the-job-training, and other controlled documents.

• Demonstrated ability to lead key projects across multiple site disciplines and successfully manage multiple, concurrent projects.

• Demonstrated ability to effectively lead others in a cross-functional organization.

• Demonstrated strong interpersonal skills with ability to influence and support others through a culture of inclusion, feedback, and empowerment.

• Demonstrated project management skills,

Preferred Experience and Skills:

• Experience in Continuous Improvement, Lean Manufacturing, Problem Solving, and/or Right First-Time methodologies.

• Experience in pharmaceutical/packaging technology equipment, barcode systems, reject/verification processes and OEM equipment.

• Experience with Manufacturing Execution Systems – preferably Werum PAS/X.

• Experience with data historian systems – preferably OSISoft PI historian.

• Experience administering Cyber Security policies and procedures to process control systems..

• Data Integrity acumen.

• PMP Certification

Our Manufacturing & Supply Division is committed to be the most trusted supplier of bio-pharmaceuticals worldwide. Our facilities, along with our external contractors, suppliers, and partners, create an interdependent global manufacturing network that’s committed to delivering a high quality, reliable supply to customers and patients on time, every time.

Who we are …

We are known as Merck & Co., Inc., Kenilworth, New Jersey, USA in the United States and Canada and MSD everywhere else. For more than a century, we have been inventing for life, bringing forward medicines and vaccines for many of the world's most challenging diseases. Today, our company continues to be at the forefront of research to deliver innovative health solutions and advance the prevention and treatment of diseases that threaten people and animals around the world.

What we look for …

Imagine getting up in the morning for a job as important as helping to save and improve lives around the world. Here, you have that opportunity. You can put your empathy, creativity, digital mastery, or scientific genius to work in collaboration with a diverse group of colleagues who pursue and bring hope to countless people who are battling some of the most challenging diseases of our time. Our team is constantly evolving, so if you are among the intellectually curious, join us—and start making your impact today.

NOTICE FOR INTERNAL APPLICANTS

In accordance with Managers' Policy - Job Posting and Employee Placement, all employees subject to this policy are required to have a minimum of twelve (12) months of service in current position prior to applying for open positions.

If you have been offered a separation benefits package, but have not yet reached your separation date and are offered a position within the salary and geographical parameters as set forth in the Summary Plan Description (SPD) of your separation package, then you are no longer eligible for your separation benefits package. To discuss in more detail, please contact your HRBP or Talent Acquisition Advisor.

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.

For more information about personal rights under Equal Employment Opportunity, visit:

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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.

Search Firm Representatives Please Read Carefully
Merck & Co., Inc., Kenilworth, NJ, USA, also known as Merck Sharp & Dohme Corp., Kenilworth, 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):

Number of Openings:

Requisition ID:R151125