Durham's Specialist, Operations provides technical support to the vaccine bulk production area to include Purification, Fermentation, and Alum Adjuvant as well as other supporting areas such as sterile goods/parts supplies. The support focuses project control activities, management of readiness activities, investigation of manufacturing deviations, coordination of Corrective and Preventative Actions (CAPA), review of GMP documentation, and continuous improvements to reduce cost of goods and reduce cycle time.

This position will support HPV vaccine production. Off-shift and weekend coverage will be required based on business unit needs and specific assignments.

Responsibilities may include but are not limited to;

• Support facility production through qualification, licensure, and ramp up.
• Actively participate on cross-functional manufacturing teams to advance projects goals and deliverables related to the vaccine process.
• Promote a culture of visibility and accuracy of the project schedule and update dashboards accordingly to highlight project status to critical milestones.
• Management of project schedule, project portfolio, and project Tier processes.
• Lead in the identification and implementation of process improvement projects, productivity initiatives and corrective actions while focusing on equipment uptime, minimizing cost and maintaining process consistency.
• Investigates deviations (both minor and major) with responsibility to interface with Operations, GVTE (Global Vaccine Technology & Engineering), Automation, and Quality approvers.
• Work with the Technology, Automation, and Quality approvers to determine the breadth and scope of the investigation to identify the appropriate root cause, complete trending analysis, and determine product disposition.
• Determines appropriate and effective corrective actions to prevent reoccurrence of the deviations and ensure they improve the Right First Time initiative.
• Foster a collaborative relationship with manufacturing floor personnel focused on high quality investigations, meaningful corrective actions, and reducing the deviation generation rate.
• Author, review, and/or edit procedures and technical documents to support regulatory filings including standard operating procedures, job aides, and learning documents.
• Working with subject matter experts (SMEs), track necessary training for operator qualification as assigned.
• Work alongside operations and lean six sigma team members to develop reliable, consistent manufacturing processes that meet cGMP requirements.
• Attends and actively participates in facility gembas, waste walkthroughs, 5S, kaizen events, or any other operations, lean six-sigma, quality, safety or environmental training/initiatives as required.
• Analyzing and implementing initiatives, training programs, and systems that will help to increase overall success within the department.

Required Experience and Skills:

• Minimum two-years (2) relevant work experience in GMP environment with BS/MS degree in chemical and/or industrial engineering or related field
• Demonstrated written and verbal communications skills
• Technical writing, scheduling, and deviation investigation experience
• Must be willing and able to lift 50 lbs

Preferred Experience and Skills (General):

• Experience with formal problem solving techniques, such as root cause analysis (RCA), failure mode effects analysis (FMEA), and/or Lean Six Sigma tools
• Experience in SAP, automation and manufacturing execution system (MES), process modeling and process improvement
• Experience in deviation management, troubleshooting and resolving manufacturing anomalies
• Supervisory or project management experience
• Experience with on-the-floor cGMP manufacturing and familiarity with regulatory requirements
• Demonstrated ability to work both independently and as a part of a team
• Strong collaboration, communication, and leadership skills

Travel: Up to 10% of the time

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. VETJOBS #EBR

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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, 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".

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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:
Regular

Relocation:
Domestic

VISA Sponsorship:
No

Travel Requirements:
10%

Flexible Work Arrangements:
Not Applicable

Shift:
1st - Day

Valid Driving License:
No

Hazardous Material(s):
N/A

Job Posting End Date:
10/30/2024
*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:R317013