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Merck Associate Specialist, Manufacturing Automation in Durham, North Carolina

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 is expanding its global recombinant vaccine production network by investing $650 million and adding a 225,000-square-foot building within the footprint of the Maurice R. Hilleman Center for Vaccine Manufacturing in Durham, NC. The new facility will be used to produce the bulk active ingredient for the HPV vaccine, comprised of fermentation, microfiltration/ultra filtration, and chromatography steps.

Approximately 614,000 people are diagnosed with certain HPV-related cancers each year. Our Company manufactures the two HPV vaccines that are predominantly utilized to eradicate these cancers globally. In recent years, countries around the world have enacted new or expanded HPV vaccination programs, which has created an unprecedented increase in global demand. The manufacturing facility in Durham will play a critical role in the network of plants that produce life-saving medicines and vaccines, including our HPV vaccines.

Job D e s c r ipti o n

The Associate Specialist Manufacturing Automation is primarily responsible for providing system administration oversight for data historian, batch reporting, and laboratory automation systems to be qualified and supporting digital innovation initiatives for a new manufacturing building at the Durham, NC facility. Responsibilities include supporting commissioning and qualification efforts, troubleshooting equipment/automation issues to improve manufacturing/laboratory performance, and maintaining the automation systems in compliance with cGMPs. The Manufacturing Automation Associate Specialist must actively support, participate and embrace an empowered team culture including significant interaction with manufacturing, quality, IT, and engineering groups.

Responsibilities may include but are not limited to:

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

  • Trouble-shooting challenging equipment / automation issues to improve manufacturing performance (e.g. yield improvements, etc.) for assigned systems

  • Maintaining the automation systems in compliance with cGMPs.

  • Providing support as a representative of a startup or existing production team providing technical assistance in fulfilling the automation requirements for the team.

  • Reviewing automation documents, preventive maintenance, and SOPs to ensure compliance with GMP and safety.

  • Developing and supporting corrective actions for investigations related to automation or IT systems.

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

  • On-floor support of manufacturing activities.

  • Provides support for business area applications.

  • Participation in Kaizen events.

Other:

  • SOP development and review.

  • Direct support of regulatory inspections and audits.

  • Direct support of validation activities and all other associated Quality functions.

  • Other duties requested by Management.

Working Relationships

  • Reports to the Associate Director or Senior Specialist of Manufacturing Automation

  • Frequent interaction with employees from other departments

  • Interacts with representatives from regulatory agencies and external suppliers

Education Minimum Requirement:

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

Preferred Experience and Skills:

  • Experience in PLCs, SCADA, DCSs, MES, Batch Operations (S88/S95), IT, and OEM equipment.

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 …

Merck & Co., Inc., Kenilworth, New Jersey, USA is known as “Merck” in the United States, Canada & Puerto Rico. We are known as “MSD” in Europe, Middle East, Africa, Latin America & Asia Pacific. We are a global biopharmaceutical leader with a diverse portfolio of prescription medicines, oncology, vaccines and animal health products.

We are driven by our purpose to develop and deliver innovative products that save and improve lives. With 69,000 employees operating in more than 140 countries, we offer state of the art laboratories, plants and offices that are designed to Inspire our employees as we learn, develop and grow in our careers. We are proud of our 125 years of service to humanity and continue to be one of the world’s biggest investors in Research & Development.

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.

If you need an accommodation for the application process please email us at staffingaadar@merck.com

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

EEOC Poster at https://www1.eeoc.gov/employers/upload/eeocselfprint_poster.pdf

EEOC GINA Supplement​ at https://www1.eeoc.gov/employers/upload/eeocginasupplement.pdf

OFCCP EEO Supplement at https://www.dol.gov/ofccp/regs/compliance/posters/pdf/OFCCPEEOSupplementFinalJRFQA508c.pdf

OFCCP Pay Transparency Rule at https://www.dol.gov/ofccp/pdf/pay-transp%20EnglishformattedESQA508c.pdf

We are an equal opportunity employer, Minority/Female/Disability/Veteran – proudly embracing diversity in all of its manifestations.

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:

Regular

Relocation:

No relocation

VISA Sponsorship:

No

Travel Requirements:

10%

Flexible Work Arrangements:

Shift:

1st - Day

Valid Driving License:

Yes

Hazardous Material(s):

Number of Openings:

1

Requisition ID: R43645

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