Specialist, Business Consulting

Job Description

Subject to applicable law, all prospective hires will be required to demonstrate that they have been fully vaccinated for COVID-19 or intend to be vaccinated for COVID-19 by November 1, 2021 or qualify for a medical or religious accommodation to this vaccination requirement. Hired candidates who are not vaccinated by November 1, 2021, and who have not been approved for a legally required medical or religious accommodation will be subject to disciplinary action up to and including termination of employment, subject to applicable law.

The successful candidate will have the opportunity to apply their enthusiasm and organizational skills as a member of a multidisciplinary team in a dynamic compliance environment supporting the operation of pharmaceutical product manufacturing facilities.

• Manage workload and prioritize needs for shared services within the Automation Department, ensuring that compliance items are completed when needed; communicating with various Automation department subgroups and engineers when requests will be completed.

• Coordinate with Process Automation Engineers to update Detailed Design Specifications, using automated software, for DeltaV control systems

• Scan executed test protocols/plans for approval in our Electronic Document Management System

• Site Administrator for Electronic Document Management system

• Ensure electronic documents are loaded into our Electronic Document Management in accordance with local site requirements/guidance, initiating technical support cases when needed.

• Manage user access for the Automation Department in our Electronic Document Management System, initiating technical support calls when needed.

• Technical writing support for department SOPs and SDLC documentation for various systems

• Manage site system inventory

• Generate automated Alarm reports for DeltaV systems for each Production area on defined schedule.

• Initiate Performance Monitoring and Preventative Maintenance protocols for each Production area, communicating due dates to respective automation engineers, and routing protocols for approval.

• Provide support for data entry for various initiatives/projects throughout the calendar year.

• Track and update the status of compliance commitments for the Automation Department

Position Assignments

· Manage workload and prioritize needs for shared services within the Automation Department, ensuring that compliance items are completed when needed; speaking with various Automation department subgroups and engineers when requests will be completed.

· Coordinate with Process Automation Engineers to update Detailed Design Specifications, using automated software, for DeltaV control systems

· Scan executed test protocols/plans for approval in our Electronic Document Management System

· Ensure electronic documents are loaded into our Electronic Document Management in accordance with local site requlations/guidance, initiating technical sponsored cases when needed.

· Manage user access for the Automation Department in our Electronic Document Management System, initiating technical support calls when needed.

· Provide input to site SOPs or job aids for Electronic Document Management System. Function as a subject matter expert and technical resource for the Kneat system, Eloquent system, Quality docs.

· Technical writing sponsorship for department SOPs and SDLC documentation for various systems

· Manage site system inventory

· Generate automated Alarm reports for DeltaV systems for each Production area on defined schedule.

· Initiate Performance Monitoring and Preventative Maintenance protocols for each Production area, speaking due dates to respective automation engineers, and routing protocols for approval.

· Provide sponsorship for data entry for various initiatives/projects throughout the calendar year.

· Track and update the status of compliance commitments for the Automation Department

Education:

· BS Degree or 5 years relevant industry knowledge

Our Manufacturing & Supply Division is dedicated to be the most unswerving supplier of bio-pharmaceuticals worldwide. Our facilities, along with our external contractors, suppliers, and partners, create an interdependent

global manufacturing network that’s hinged on to delivering a high quality, reliable supply to customers and patients on time, every time.

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.

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 Poster

EEOC GINA Supplement​

OFCCP EEO 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.

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:R143464