What are the responsibilities and job description for the Specialist, Business Consulting position at Merck?
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.
The Manufacturing Execution System (MES) Specialist / Business Consultant acts as a subject matter expert and an area(s) site MES key point of contact, for Operations areas utilizing electronic Master Batch Records. The MES Specialist’s primary responsibility is to ensure that the deployment of the Werum PAS-X electronic Master Batch Records are successfully and compliantly designed, developed, deployed, and supported to maximize business benefits and are in line with site business process and technical standards. The MES Specialist will have regular direct interaction with site COMET Data Center of Excellence (CoE), Tech Ops, Operations, Quality, and IT plus collaborate with the above site MES CoE. The MES Specialist will also be accountable for SAP-MES data integration, along with driving MES training, collaboration, benefit realization, and standardization across the site. The Specialist is responsible for following standard processes and procedures in performing their duties. These include cGMP regulations, SOPs and global business processes.
Under the management and supervision of the MES Lead, the MES Business Consultant is responsible for activities that include the following:
- Partner with local Tech Ops, Quality, and Operations resources as well as ESP to design, develop, revise, train, and sustain electronic Master Batch Records, bringing together knowledge of manufacturing processes, and standard Werum generic master batch record (GMBR) configuration.
- Executes the appropriate change control and electronic Master Batch Record life-cycle actions and processes to assure the MES system is in a state of control and compliance.
- Participates in the creation and execution of the site MES SOPs and Werum training strategy and sustainment for end users.
- Identifies and implements continuous process improvement opportunities.
- Collaborates and assists with troubleshooting to efficiently resolve manufacturing problems, providing MES support to ongoing Electronic Batch Record (EBR) operations.
- Knowledge of Quality Systems and Regulatory Standards to provide assurance and foster quality decisions with project teams and their site Quality unit.
- Assists in external agency inspections as needed.
Position Qualifications:
Education Minimum Requirement:
- Bachelor’s Degree or five (5) years MES authoring/ support experience
Required Experience and Skills:
- Minimum three (3) years of experience in a production regulated industry. Manufacturing operations or direct support experience within technology or quality
- Direct experience with MES
- 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
- High personal integrity, credibility, and energy
- Excellent communication and influencing skills
- Strong written and verbal communication skills
Preferred Experience and Skills:
- Experience with Project Management and/or Change Control
- Knowledge of SAP
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
EEOC GINA Supplement
OFCCP EEO Supplement
OFCCP Pay Transparency Rule
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:
RegularRelocation:
No relocationVISA Sponsorship:
NoTravel Requirements:
No Travel RequiredFlexible Work Arrangements:
Shift:
1st - DayValid Driving License:
Hazardous Material(s):
Number of Openings:
1Requisition ID:R44227
