Senior Specialist, Manufacturing Automation

Job Description

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.

We have an exciting opportunity for a Senior Specialist, Manufacturing Automation for a capital project start-up in Durham, North Carolina. The facility will include end-to-end processing of drug substance, drug product, including biotech culture growth, harvest, lyophilization, product inspection, and quality control laboratories.

Responsibilities

• 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

• 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

• Identify and implement process/equipment improvements and manufacturing efficiencies

• Maintain technical documentation

Working Relationships

• Reports to the Associate Director Manufacturing Automation

• Frequent collaboration with employees from other departments

• Interacts with representatives from regulatory agencies and external suppliers

Education Requirement

• Bachelor degree or higher in Engineering or Computer Science

Experience and Skills

Required

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

• Minimum of five (5) years 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 2) | Allen Bradley PLC (or equivalent) | 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

• Strategic and effective communication and influencing skills both verbal and written

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Preferred

• Working with Information Technology teams

• Regulatory audits and working knowledge of data integrity principles

• Understanding of Lean Manufacturing /Six Sigma methodology

• Team building and strategic leadership, interpersonal and communication skills

Our Manufacturing & Supply Division is dedicated to being the most trusted supplier of bio-pharmaceuticals worldwide. Our facilities, along with our external contractors, suppliers, and partners, create a reliable global manufacturing network that’s devoted 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 …

In a world of rapid innovation, we seek brave Inventors who want to make an Impact in all aspects of our business, enabling breakthroughs that will affect generations to come. We encourage you to bring your disruptive thinking, collaborative spirit and diverse perspective to our organization. Together we will continue Inventing For Life, Impacting Lives while Inspiring Your Career Growth.

Invent. Impact. Inspire.

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.

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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:

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Number of Openings:

Requisition ID:R118157