Job Abstract

Job Description

The Specialist, Operations supports manufacturing operations in the Live Virus Vaccines organization.  This high impact role in our Company Manufacturing assures that products manufactured comply with cGMPs, operating procedures and other applicable regulations.  This role focuses on shop floor compliance and implementation of lean manufacturing initiatives aligned with department goals.

Position Responsibilities:

• Supports the managers in the direct processing of materials to ensure attainment of business results

• Develops an in-depth knowledge of the equipment and process

• Builds knowledge of the company, process, clients and/or customers

• Applies team effectiveness skills, listening and integrating diverse perspectives from across the workgroup

• Manage conflict and effect resolution of technical and personal challenges using standard procedures is key as is openness to change and the ability to effect positive change

• Contributes and adds value to the achievement of team goals

Compliance:

• Ensure compliance with safety and environmental practices, cGMPs and SOPs in the work area

• Demonstrate integrity, credibility, and flexibility in their daily performance so as to motivate others to do the same

Business Expertise:

• Perform a thorough review of batch records and related GMP documentation, identifying and resolving discrepancies in a timely manner and implementing corrective actions to improve the batch record execution/review process

• Work with subject matter experts (SME’s) to provide/track necessary training for operator qualification as assigned

• Participate in the design and implementation of training and development programs and training materials

• Foster a collaborative relationship with manufacturing floor personnel focused on high quality investigations, meaningful corrective actions and reducing the deviation generation rate

• Determines/implements appropriate and effective corrective and/or preventative actions (CAPAs) to prevent reoccurrence of deviations and ensure they improve the Right First Time metrics

Problem Solving | Decision Making:

• Identifies and solves a range of problems in straightforward situations; analyzes possible solutions and assesses each using standard procedures

• Makes decisions that are guided by site policies and procedures

• Collaborates with supporting departments such as Quality, Tech Ops and Maintenance to solve problems in an efficient and compliant manner

• Consults with manager on more complex decisions and issues that impact other departments

Project | Resource Management:

• Accountable for contribution to project team or sub-team, may manage/led a small project team

• Collaborates with team members in the identification and implementation of continuous improvement initiatives and action plans

• Supports activities in the areas of cost containment, efficiency, productivity, energy conservation, waste minimization, operational excellence, and lean practices

• Aware of costs and assists in controlling costs related to own work

Minimum Required Education, Experience and Skills:

• Bachelor’s degree or higher, preferably in Science, Engineering, Business Administration, or another technical field with two (2) years of relevant experience in manufacturing

OR

• High School Diploma/GED with four (4) years of relevant experience in manufacturing or military service

AND

• Willing and able to work off-shifts and weekends as needed

Required Experience and Skills:

• Familiarity with cGMPs in pharmaceutical industry

• Demonstrates strong problem-solving skills and a hands-on approach to problem solving

• Ability to work independently

Preferred Experience and Skills:

• Formal problem-solving techniques, such as root cause analysis (RCA), failure mode effects analysis (FMEA) and/or Lean Six Sigma Tools

• Manufacturing plant experience in operational capacity

• Working in a Union environment

• SAP or other Enterprise Software

• Knowledge of CFR regulations

Shift and Hours:

• 2nd shift M-F - 4pm - 12am

• Willingness to work off-shift and weekends to support production

• Rotation of weekend coverage

#MSJR

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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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. 

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