Senior Specialist, Technical Operations

Job Description
We invite you to join our Team!
Building 63A Syringe Filling Facility Project team is seeking a highly motivated individual to fill an open position to lead the start-up and tech transfer for a new vaccine formulation & filling facility at the West Point site. Facility start-up will include design, commissioning, equipment qualification and vaccine drug product process demonstration in support of facility licensure.
The Senior Specialist, Technical Operations is responsible for providing technical assist for Commissioning & Qualification and automation recipe development while actively drafting change request, single use design, MES , and protocols for Tech transfer, Process Performance Qualifications. In this role, the Specialist will work as an individual contributor as well as a lead co-ordination for different workstreams within a cross-functional group that includes Global Engineering Services, Global Technical Operations, West Point Operations, Quality, Automation, and others.
Additional responsibilities may include:

• Partner with cross functional team to develop process/procedures and complete successful qualification of equipment/processes.
• Provide technical expertise for unit operation for design reviews, process hazard assessments, quality risk assessments, factory and site acceptance testing, qualification.
• Assist successful demonstration of unit operations for the technology transfer of vaccine manufacturing process to the new manufacturing facility.
• Assist single use workstream End to End activities.
• Author and update technical and manufacturing documents necessary for process design/definition, engineering studies, process demonstrations, and validation.
• Develop and execute change control inclusive of change definition, risk assessments, impact assessments, task execution, implementation, and support of associated regulatory filings.
• Assist process improvement projects and complex manufacturing investigations during development, engineering and Process Performance Qualifications batches execution.
• Examine issues from diverse perspectives (safety, compliance, automation, equipment, process, and people) in order to best understand and resolve the root cause.
• Assist regulatory submission preparation and inspections for the facility.
• Lead the integrated Deviation Management team once that facility reaches operational state

Minimum Requirements:

• Bachelor 's Degree in an Engineering or Science Related field.
• Minimum five (5) years of experience in GMP manufacturing and/or technical support of GMP manufacturing operations; Minimum four (4) years with a Master 's Degree .
• Proficiency in English, in oral and written
• Demonstrated a strong performance record and have excellent project management skills.
• Experience in biologics, vaccine or bulk sterile manufacturing facilities.
• Highly developed communication and teamwork skills.
• Be able to work independently and drive significant portions of the project.
• Willing to travel up to 10%

Preferred Experience and Skills:

• Experience working with vaccines manufacturing process.
• Experience with a Deviation Management program (Root Cause Analysis , Corrective/Preventative Actions, Human Performance, among others).
• Skills with Digital and Data Visualization tools.

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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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, 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.
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:
06/7/2024
*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.
Job Posting End Date:06/07/2024
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:R293405