Spclst, Operations

Job Description

The Maurice R. Hilleman Center for Vaccine Manufacturing is located in Durham, NC. Due to the importance of this facility in our Company Vaccine Manufacturing network, the facility has seen rapid growth in production volumes and new employees over the last several years; currently Durham employs 1,000+ people.

This role as an Operations Specialist will be an energetic individual with strong interpersonal, leadership, and collaboration skills responsible for supporting Operational Readiness projects and initiatives for a new manufacturing facility. This role will contribute to the overall performance and results of a E2E drug substance department.

This position is on-site and is a rotating 12-hour shift on either night shift or day shift following the 2-2-3 schedule.

Responsibilities may include but are not limited to;

• Partnering with the Operations management team to create and execute strategies that support design, development, delivery and evaluation of projects related to steady-state production and/or continual process improvement.
• Authoring and reviewing documents and SOPs.
• Batch Record Review
• eLog Review
• Lead safety investigations
• Lead Problem Solving initiatives
• Equipment and process troubleshooting
• Supporting on-shift Operations Coaches (M1)
• Author deviations and works to coordinate, develop and implement Corrective Actions/Preventive Actions (CAPAs)
• Lead implementation of MPS principles on the shop floor
• Sample management
• Ability to effectively support, upskill and mentor new employees
• Analyzing and implementing initiatives that will help to increase overall success within the department.
• Effectively using metrics and measurement to ensure that projects and initiatives result in desired outcomes.
• Ability to prioritize workload under guidance from management.

Education Minimum Requirement:

• High School Diploma AND at least Five (5) years in a manufacturing, technical, support, or Military role. OR
• Bachelor's degree in a technical field AND at least Three (3) years in a manufacturing, technical, support, or Military role.
• Bachelor's degree and at least One (1) year of experience in a direct GMP, biotechnology, manufacturing setting.

Required Experience and Skills:

• Experience working in a GMP environment
• Demonstrated written and verbal communications skills
• Ability to foster a collaborative work environment
• Demonstrated interpersonal, technical aptitude, and problem-solving skills
• Strong team skills, including the ability to coach/develop work teams, provide training, motivate/empower others, and resolve conflict
• Must be flexible and able to manage multiple priorities

Preferred Experience and Skills:

• Understanding of MPS methodologies
• Experience with shop-floor cGMP manufacturing and related systems (i.e. SAP)
• Familiarity with pharmaceutical regulatory requirements
• Project management and data analysis skills
• Technical writing experience
• Experience with facility, equipment and/or process start up activities in a cGMP environment
• Demonstrated ability to work independently
• Production planning / scheduling experience

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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:

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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.

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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, 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:
Domestic

VISA Sponsorship:
No

Travel Requirements:
10%

Flexible Work Arrangements:
Not Applicable

Shift:
1st - Day, 3rd - Night

Valid Driving License:
No

Hazardous Material(s):
N/A

Required Skills:
Adaptability, Adaptability, Applied Engineering, Biological Manufacturing, Biotechnology, cGMP Compliance, Collaborative Communications, Column Chromatography, Communication, Computer Literacy, Corrective Action Management, Data Analysis, Environmental Health and Safety (EHS) Management, Equipment Set Up, GMP Compliance, Leadership, Lean Manufacturing Tools, Management Process, Operations Support, Pharmaceutical Management, Preventive Action, Process Improvements, Process Monitoring, Process Optimization, Process Troubleshooting {+ 5 more}

Preferred Skills:

Job Posting End Date:
06/28/2025
*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:R353923