Company

Merck & Co., Inc.See more

addressAddressDurham, NC
type Form of workFull-Time
CategoryInformation Technology

Job description

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 human papillomavirus (HPV) 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/ultrafiltration, 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.
The Manufacturing Automation Specialist position shall support the expansion of a GMP testing laboratory at a manufacturing facility for sterile vaccine products. Responsibilities include supporting computer system validation, implementing process control and data collection, and troubleshooting in compliance with SDLC, cGMP, safety, and environmental regulations. The Manufacturing Automation Specialist must actively support, participate, and embrace an empowered team culture including significant interaction with manufacturing, quality, IT, and engineering groups. This role supports a large spectrum of sophisticated automated systems within Laboratory Operations; providing multiple opportunities to learn new automation technologies and make a positive impact.
Primary activities include, but are not limited to:
  • Understands and supports all Good Manufacturing Practices (GMPs), safety, and environmental regulations.
  • Coordinates with staff and contractors to guarantee timely qualification of all new and updated systems.
  • Authors and reviews automation documents and SOPs to ensure compliance with Good Manufacturing Practices and safety.
  • Technical leadership for the assigned area and system(s) to ensure a compliant, reliable supply of product and on time project execution and system delivery.
  • Provide technical guidance/support including authoring or review of system qualification documents, change control, Quality Notifications (QNs), and other key automation related processes
  • Participates in audits and training programs in the area of responsibility.
  • Evaluates automated and information technology systems and develops strategies to optimize and ensure quality and stability of automation systems through process improvement, future expansion, replacement, or upgrade.
  • Leads troubleshooting and investigations of automation incidents to prevent recurrence, including the development and implementation of corrective actions and change controls.
  • Initiate and lead collaboration within the Operations, Quality, and Technical organizations to resolve complex problems.
  • On-floor support of manufacturing/laboratory activities.

Education Minimum Requirement:
  • B.S., B.A., or greater preferably in Engineering, Science, or Information Technology

Required Experience and Skills:
  • Minimum 2 yrs. of experience in automation or equivalent.
  • Minimum of 2 yrs. of GMP computer systems validation experience and systems lifecycle development methodology experience required.
  • Strong understanding of manufacturing principles/ processes and ability to translate manufacturing and business requirements into Automation/digital solution
  • Strong data integrity acumen
  • Proven track record of analytical skills, problem-solving, and attention to detail

Preferred Experience and Skills:
  • Experience in the following areas is desired: PLCs, SCADA, laboratory equipment, and/or PI.
  • Lean Manufacturing /Six Sigma methodology.

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., Rahway, 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. #VETJOBS #EBRG
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:
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:
EEOC Know Your Rights
EEOC GINA Supplement
Pay Transparency Nondiscrimination
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.
Learn more about your rights, including under California, Colorado and other US State Acts
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:
Regular
Relocation:
Domestic
VISA Sponsorship:
No
Travel Requirements:
No Travel Required
Flexible Work Arrangements:
Hybrid
Shift:
1st - Day
Valid Driving License:
No
Hazardous Material(s):
None
Refer code: 7522722. Merck & Co., Inc. - The previous day - 2023-12-31 12:56

Merck & Co., Inc.

Durham, NC
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