Specialist, Operations (Nights)

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.

Position Description

As part of our Company's Vaccine Manufacturing Organization, the Durham team is seeking a highly motivated individual to serve as a day shift Operations Specialist. The Operations Specialist will be an integral member of the operations team with responsibility for direct support of operations on the production floor, batch record review, and problem solving to drive short to long-term continuous improvement initiatives. This position will be expected to support all production steps in the live virus vaccine formulation and filling area including Thaw/Pool/Fill, Lyophilization, and Capping & Inspection. Primary responsibilities and necessary skills include, but are not limited to the following:

• Provides support for all production activities, resolving critical issues on a daily basis to ensure consistent supply. Facilitates real-time root cause analysis to solve routine production and equipment problems.
• Assists shift managers in providing leadership to the production floor. Capable of providing primary leadership to team during extended periods of manager absence such as vacations.
• Works in an inclusive manner, treating all team members with respect and helping to create a positive and continuously improving work environment within the team.
• Possesses basic compliance experience (GMP and Environmental Health & Safety) and is capable of participating positively in both internal and external regulatory inspections.
• Executes and manages Operations batch record review within established timelines for release and effectively liaisons with Quality to resolve comments in a timely manner.
• Provides technical expertise and oversight on the production floor, including critical processing observation and real-time feedback, understanding the full process requirements (compliance, equipment, regulatory) in order to best understand and resolve production issues.
• Facilitates routine meetings and manages metrics as necessary to ensure the team communicates effectively and routinely meets its commitments.
• Drives continuous improvements and corrective actions within the team. Works with production floor personnel to develop and implement the counter-measures necessary to improve production and equipment reliability as well as the compliance posture of the team.
• Consistently meets commitments including owning and completing formal corrective and preventative actions for the team within defined timelines.
• Understands lean principles and applies these concepts to all aspects of the production environment. Recognizes and investigates opportunities for improving the business through financial savings etc.
• Serves as liaison between the team and support groups in resolving day to day issues and in support of various projects and initiatives including the tech transfer of new products.
• Works independently and is capable of balancing shifting priorities without introducing disruption to the organization. Capable of working through uncertainty with minimal levels of manager direction.

In addition to these responsibilities and more specific skills, this position will require the ability to work in a team environment collaborating effectively with other team members as well as external stakeholders. Good verbal and written communication skills will be very important in this role.

Primary hours will be 12-hour night shift (6:00 PM to 6:30 AM) on a rotating 2-2-3 schedule. Note that this schedule does include working alternating weekends.

Education Minimum Requirement:

• Bachelor’s Degree (science/chemical, mechanical, or electrical engineering preferred)

Required Experience and Skills:

• Minimum 1 year of relevant experience in a manufacturing, technical, or mechanical support role in a high-volume lean operation.
• Working knowledge of cGMP and of regulatory requirements as they apply to the vaccine and/or pharmaceutical industry.
• Highly motivated with excellent interpersonal, problem solving, and technical skills.

Preferred Experience and Skills:

• cGMP experience in an aseptic manufacturing environment.
• Experience using inventory management and maintenance planning software such as Systems Applications and Products, automated control systems, and electronic batch record systems.
• Experience with basic problem solving techniques such as root cause analysis and/or Lean Six Sigma.
• Project management skills and experience implementing small-sized assignments.
• Technical writing and document review experience (i.e. deviations, change requests, standard operating procedures, batch records, protocols, etc.)

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 [email protected]
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:

Relocation:

VISA Sponsorship:

Travel Requirements:

Flexible Work Arrangements:

Shift:

Valid Driving License:

Hazardous Material(s):

Number of Openings:

Requisition ID:R75506