What are the responsibilities and job description for the MES Integrator for VMF Technical Operations position at Merck?
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.
Our company is a global health care leader with a diversified portfolio of prescription medicines, vaccines, and consumer health products, as well as animal health products. Today, we are building a new kind of healthcare company - one that is ready to help create a healthier future for all of us.
Our ability to excel depends on the integrity, knowledge, imagination, skill, diversity, and teamwork of people like you. To this end, we strive to create an environment of mutual respect, encouragement, and teamwork. As part of our team, you'll have the opportunity to collaborate with talented and dedicated colleagues while developing and expanding your career.
At the Vaccine Manufacturing Facility in Durham, North Carolina, the Global Vaccine Technology & Engineering (GVTE) team is seeking candidates to fill Integrated Process Team (IPT) Engineering positions to partner with Manufacturing Operations, Quality Operations, and Process Automation. GVTE provides technical engineering and manufacturing support for the production of our company's live virus vaccines at Durham. The Maurice R. Hilleman Center for Vaccine Manufacturing is located in northern Durham, North Carolina. This state of the art facility, started in 2004, is manufacturing our company's lifesaving vaccines. Due to the importance of this facility in our company’s Vaccine Manufacturing Supply Chain, the facility has seen rapid growth in production volumes and new employees.
We currently have an exciting opportunity for an Engineer to join our vaccine manufacturing Technical Operations department within our company Manufacturing Division, supporting the management of electronic batch records for a sterile fill, finish, and lyophilization vaccine manufacturing facility in Durham, NC.
The Manufacturing Execution System (MES) Integrator for VMF Tech Ops will be part of a cross-functional team charged with collaboration with the MES PAS-X Automation team and management of electronic batch records. The role requires strong project management skills for the implementation of electronic batch record updates and an ability to execute multiple projects across the IPT. The role will be responsible for managing updates to electronic batch records utilizing MES PAS-X, ensuring batch record updates meet system development lifecycle (SDLC) requirements, and ensuring that long term project milestones are met. Strong communication and collaboration skills are essential. The successful candidate will also have a foundation in current Good Manufacturing Practices. Enthusiasm for continuously learning is a requirement.
Primary Activities:
- Coordination of electronic batch record updates with MES Automation and Operations teams
- Generation of change control records to update electronic batch records
- Revision and approval of SDLC documentation in support of electronic batch record updates
- Planning and scheduling of cross-functional projects to ensure project timelines are met
- Supporting all quality and safety initiatives
- Provide technical support to the manufacturing shop floor for in-process analytics, controls, and troubleshooting
- Keeping their supervisor current on the progress of projects, and making improvement recommendations on production procedures
Qualifications
Required:
- Bachelor degree in an Engineering or Science related field
- Minimum 2 years post-bachelors degree experience in GMP manufacturing and/or technical support of GMP manufacturing operations or military experience.
- Strong communication, leadership, and teamwork skills.
Preferred:
- Experience with MES PAS-X and TrackWise
- Experience with optimizing aseptic processing operations such as formulation, filling, lyophilization, or automated inspection processes.
- Familiarity with process risk assessment tools, Quality by Design principles, and Lean/Six Sigma methodologies
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.
US and Puerto Rico Residents Only
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:
Flexible Work Arrangements:
Not SpecifiedShift:
1st - DayValid Driving License:
Hazardous Material(s):
Number of Openings:
1Requisition ID:R56049
