Senior Specialist, Technical Operations

Job Description

We invite you to join our team!

Our Engineers collaborate internal and external manufacturing operations remain operational, continuously improve and innovate. With our extensive range of facilities and environments, our Engineers have opportunities across many diverse areas including Biological, Chemical, Automation, Capital Projects, Maintenance, Safety, Process Development, Technical Services, Utilities and Validation.

Our 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 assistance for Commissioning & Qualification and automation recipe development while actively drafting change request, single use design, electronic badge system, and protocols for Tech transfer, Process Performance Qualifications. In this role, the Senior 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 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.

• Collaborate successful demonstration of unit operations for the technology transfer of vaccine manufacturing process to the new manufacturing facility.

• Lead and co-ordinate 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 including of change definition, risk assessments, impact assessments, task execution, implementation, and assist of associated regulatory filings.

• Assist process improvement projects and complex manufacturing investigations during development, engineering and Process Performance Qualifications batches execution.

• Assist digital and data visualization initiatives.

• 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.

Education:

• Bachelor's degree in an Engineering or Science Related field

• Minimum five (5) years of experience in Good Manufacturing Practices manufacturing and/or technical support of Good Manufacturing Practices manufacturing operations; Minimum four (4) years with a Master's Degree.

Required Experience and Skills:

• Proficiency in English, in oral and written.

• Effective 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.

Preferred Experience and Skills:

• Skills and expertise with Digital and Data Visualization tools is preferred. Including PowerApps, PowerBi, Python.

• Knowledge of process risk assessment tools, Quality by Design principles, and Lean/Six Sigma methodologies/certification.

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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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.

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, 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".

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:

05/30/2024

*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.

Job Posting End Date: 05/30/2024

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: R293404