Specialist, Operations

Job Description

The Specialist, Operations supports manufacturing operations in the Vaccines HPV Bulk IPT organization. This high impact role in our Company assures that products manufactured comply with current Good Manufacturing Practice (cGMPs), operating procedures and other applicable regulations. This role focuses on continuous improvement, shop floor compliance and implementation of lean manufacturing initiatives aligned with department goals.

NOTE: This position is 3rd shift Sunday through Thursday.

Position Description:

• Assists 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
• Tool development for shop floor execution and operability of manufacturing processes

Under the direction of an Associate Director, the successful candidate will be responsible for:

Compliance:

• Ensure compliance with safety and environmental practices, cGMPs and Standard Operating Procedures (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 mutually beneficial relationship with manufacturing floor personnel focused on high quality investigations, meaningful corrective actions and reducing the deviation generation rate
• Establishes/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:

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

Decision Making:

• Makes decisions that are guided by site policies and procedures
• Partners 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 Management:

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

Resource Management:

• 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

OR

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

Required Experience and Skills:

• Demonstrates strong leadership capability, problem-solving skills and a hands-on approach to problem solving.
• One to two-years cGMP experience in a sterile, bulk or finished pharmaceutical environment.
• Ability to work independently.
• Willingness to work off-shift and weekends.

Preferred Experience and Skills:

• People management background.
• One to 2 years of cGMP experience in a sterile, bulk or finished pharmaceutical environment.
• Manufacturing plant experience in operational capacity.
• Union environment background.

#MSJR

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.

As an Equal Employment Opportunity Employer, we provide equal opportunities to all employees and applicants for employment and prohibit discrimination on the basis of race, color, age, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, disability status, or other applicable legally protected characteristics. As a federal contractor, we comply with all affirmative action requirements for protected veterans and individuals with disabilities. For more information about personal rights under the U.S. Equal Opportunity Employment laws, visit:

EEOC Know Your Rights

EEOC GINA Supplement

We are proud to be a company that embraces the value of bringing together, talented, and committed people with diverse experiences, perspectives, skills and backgrounds. The fastest way to breakthrough innovation is when people with diverse ideas, broad experiences, backgrounds, and skills 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, Monday - 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".

The salary range for this role is
$77,700.00 - $122,300.00

This is the lowest to highest salary we in good faith believe we would pay for this role at the time of this posting. An employee's position within the salary range will be based on several factors including, but not limited to relevant education, qualifications, certifications, experience, skills, geographic location, government requirements, and business or organizational needs.

The successful candidate will be eligible for annual bonus and long-term incentive, if applicable.

We offer a comprehensive package of benefits. Available benefits include medical, dental, vision healthcare and other insurance benefits (for employee and family), retirement benefits, including 401(k), paid holidays, vacation, and compassionate and sick days. More information about benefits is available at https://jobs.merck.com/us/en/compensation-and-benefits .

You can apply for this role through https://jobs.merck.com/us/en (or via the Workday Jobs Hub if you are a current employee). The application deadline for this position is stated on this posting.

San Francisco Residents Only: We will consider qualified applicants with arrest and conviction records for employment in compliance with the San Francisco Fair Chance Ordinance

Los Angeles Residents Only: We will consider for employment all qualified applicants, including those with criminal histories, in a manner consistent with the requirements of applicable state and local laws, including the City of Los Angeles' Fair Chance Initiative for Hiring Ordinance

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:
No relocation

VISA Sponsorship:
No

Travel Requirements:
10%

Flexible Work Arrangements:
Not Applicable

Shift:
3rd - Night

Valid Driving License:
No

Hazardous Material(s):
n/a

Required Skills:
Adaptability, Adaptability, Business, cGMP Compliance, Column Chromatography, Communication, Computer Literacy, Data Analysis, EHS Compliance, Environmental Health and Safety (EHS) Management, Equipment Set Up, GMP Compliance, Lean Manufacturing Tools, Lean Process Improvements, Maintenance Troubleshooting, Management Due Diligence, Management Process, Manufacturing Processes, Operational Excellence, Operations Support, People Management, Problem Solving, Process Monitoring, Process Optimization, Process Troubleshooting {+ 5 more}

Preferred Skills:

Job Posting End Date:
07/17/2025
*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:R356825