Job Description
P3 Rota E2E Job Description:
The West Point ROTA E2E organization is seeking a highly motivated individual for the role of Senior Specialist, Engineering within the ROTA E2E Strategic Projects Technical Operations team. This role will provide end-to-end technical support for commercial vaccine products within the ROTA Organization. The incumbent will have the opportunity to contribute to the performance and results of multiple Vaccine manufacturing and Packaging areas by providing technical guidance and anticipating and interpreting customer needs to identify and implement solutions.
Position Responsibilities
- The Senior Specialist, ROTA E2E Technical Operations, is responsible for leading and executing technical projects through all phases, including project planning, management, and execution.
- Support, execute, and/or lead continuous improvement projects aimed at increasing compliance, simplifying, and standardizing processes, and gaining efficiencies. Works as an individual contributor, as part of a team, or as a project lead.
- Complete and/or lead projects to enhance the performance of our processes. This includes investigating Corrective/Preventive Actions (CAPAs), initiatives aimed at improving Right-First-Time performance, reducing deviations, and value capture projects focusing on improving yield and efficiency, reducing costs, or lowering processing cycle times.
- Manage project timelines to ensure compliance and customer deadlines are met. Escalates potential delays and develops remediation plans as needed.
- Collaborate effectively with Coaches, Operators/Mechanics, support groups, Quality, Planning, project teams, and external component and equipment vendors.
- Examine complex issues from diverse perspectives (safety, compliance, automation, equipment, process, and people) to understand and effectively resolve the root causes.
- Provide advanced technical support to manufacturing for complex problems and issues related to both processes and equipment.
- Design, conduct, review, and approve experimental protocols as necessary, utilizing the Technical Operations lab facilities and/or full-scale production equipment.
- Author, update, and review technical and manufacturing documents required for engineering studies and change controls.
- Support regulatory inspection activities.
- Provide on-the-floor support for complex operational and technical (process/equipment) issues.
- Supports team objectives related to safety, environmental standards, and compliance.
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Education Minimum Requirement:
- Bachelor's degree in engineering or other equivalent technical field
Required Experience and Skills:
- Minimum five (5) years post-bachelor degree experience in a GMP functional area or support of a GMP functional area, such as Operations, Technical Operations, Technology, Engineering, and/or Maintenance (or M.S degree with 3 years of experience)
- Strong communication, collaboration skills, leadership, and ability to drive accountability.
- Experience in Biologics, vaccine, or bulk sterile manufacturing facilities.
- Change control and/or project support role.
- Demonstrated strong performance record and excellent project management skills.
- Experience leading and managing departmental or cross-functional teams.
Preferred Experience and Skills:
- Proficiency with pharmaceutical industry technical business processes such as: Change control author/reviewer, deviation management, technical protocols/reports, and BLA/MAA regulatory license documents.
- Experience in technology transfer and/or start-up projects.
- Experience in Biologics, vaccine, or bulk sterile manufacturing facilities.
- Regulatory inspection presentation experience with external regulatory authority representatives
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.
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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We are proud to be a company that embraces the value of bringing diverse, talented, and committed people together. The fastest way to breakthrough innovation is when diverse ideas 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".
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:
1st - Day
Valid Driving License:
No
Hazardous Material(s):
n/a
Job Posting End Date:
01/9/2025
*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:R328629