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Senior Specialist, Operations

3 months ago

Durham, North Carolina, United States Merck Full time

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.

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.

Responsibilities

  • 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

Education Requirement

  • Bachelor Degree (science/chemical, mechanical, or electrical engineering preferred)
  • Bachelor of Science (B.S.) degree in Engineering (such as Chemical, Mechanical, Bio-Engineering, Bio-Medical Engineering, Industrial Engineering, etc.) or Science Fields (such as Chemistry, Biology, Microbiology, etc.) strongly preferred

Experience and Skills

Required

  • Minimum four years relevant 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 strategic and effective interpersonal, problem solving, and technical skills
  • Principled and strong verbal and written communications
  • Work in a Team environment collaborating effectively with other team members as well as external stakeholders

Preferred

  • cGMP in an aseptic manufacturing environment
  • Inventory management and maintenance planning software such as Systems Applications and Products, automated control systems, and electronic batch record systems
  • 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.)

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.

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.

We are an Equal Opportunity Employer, committed to fostering an inclusive and diverse workplace. All qualified applicants will receive consideration for employment without regard to race, color, age, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, or disability status, or other applicable legally protected characteristics. For more information about personal rights under the U.S. Equal Opportunity Employment laws, 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.

Learn more about your rights, including under California, Colorado and other US State Acts

U.S. Hybrid Work Model

Effective September 5, 2023, employees in office-based positions in the U.S. will be working a Hybrid work consisting of three total days on-site per week, generally Tuesday, Wednesday and either Monday or Thursday, although the specific days may vary by site or organization, with Friday designated as a remote-working day, unless business critical tasks require an on-site presence. This Hybrid work model does not apply to, and daily in-person attendance is required for, field-based positions; facility-based, manufacturing-based, or research-based positions where the work to be performed is located at a Company site; positions covered by a collective-bargaining agreement (unless the agreement provides for hybrid work); or any other position for which the Company has determined the job requirements cannot be reasonably met working remotely. Please note, this Hybrid work model guidance also does not apply to roles that have been designated as "remote".

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:

Yes

Travel Requirements:

10%

Flexible Work Arrangements:

Not Applicable

Shift:

1st - Day

Valid Driving License:

No

Hazardous Material(s):

N/A

Job Posting End Date:

08/6/2024

*A job posting is effective until 11:59:59PM on the day BEFORE the listed job posting end date. Please ensure you apply to a job posting no later than the day BEFORE the job posting end date.

Job Posting End Date:08/06/2024

A job posting is effective until 11:59:59PM on the day BEFORE the listed job posting end date. Please ensure you apply to a job posting no later than the day BEFORE the job posting end date.

Requisition ID:R306669