Specialist, Operations

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 VMF team is seeking a highly motivated individual to serve as an Operations Specialist within the Operations Manufacturing Support team. In this role, you must be able to work efficiently in a fast-paced environment and be hands-on when called for by the situation. This role requires the ability to distill large quantities of complex data into simplified reporting and actionable measures, strong problem-solving skills, rapid disciplined decisions and prioritization of work. The position must also demonstrate strong collaboration and communication skills to enable interfacing with both internal contacts (site level) and external contacts (external customers, sister sites, vendors) to support these initiatives.

The position requires strong technical writing and problem-solving skills. You will support critical project initiatives at the site and be involved in developing and implementing corrective actions. Enthusiasm for continuously learning is a requirement.

Responsibilities include, but are not limited to:

• Supports the end-to-end product Value Stream Map driving production improvements, inventory management, cost reductions, and standard work at the shop floor level.
• Collaborates with Operations, Technology and Quality to author regulatory inspection observation responses and completes remediation projects, as required.
• Author and own execution of Operations protocols
• Assist in development of and own Operations corrective actions
• Author and revise Standard Operating Procedures
• Support of internal and external regulatory inspections, presenting on topics as needed.
• Day shift Operations representative for various site needs (Quality Assessments, Process Simulation support, etc.)
• Leads/Supports production and quality projects and process system improvements
• Participate in or lead problem-solving of real-time shop floor issues
• Support investigations of process deviation events, up to an including authoring and leading Quality Notification closure.
• Provide expertise to the production floor, understanding the full process requirements (safety, compliance, equipment, regulatory) in order to best understand and resolve production issues.
• 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.
• Potential to work on shift directly with an Operations team as needed for shop floor support.

Education Minimum Requirement

• Bachelor's degree in a Science or Production related field required.
• 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

Required Experience and Skills

• Minimum of 2 years of experience in a GMP regulated industry.
• Technical writing experience, i.e. investigations, change requests, standard operating procedures, batch records, protocols.
• Must be able to work both independently and within multi-functional teams in a fast-paced environment.

Preferred Experience and Skills

• Sterile manufacturing shop floor experience highly preferred.
• Working knowledge of cGMPs and of regulatory requirements as they apply to the vaccine/pharmaceutical industry.
• Experience with formal problem-solving techniques and a hands-on approach to problem-solving, such as root cause analysis and/or Lean Six Sigma tools.
• Experience using inventory management and maintenance planning software (MRP/ERP) such as SAP, automated control systems and electronic batch record systems.
• Experience managing against metrics and scorecards in a business environment.
• Experience with presenting to an internal / regulatory auditor.
• Advanced knowledge of Excel, Minitab, JMP, and/or Statistical analysis.
• Six Sigma certification.

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.

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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:

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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".

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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:

Relocation:

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Job Posting End Date:

*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:08/02/2024

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:R305505