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Job Description

**NOTICE FOR INTERNAL APPLICANTS:** ​

Please review the Global Job Posting and Employee Placement Policy (https://thesource.merck.com/uep?id=kb\_article&sysparm\_article=KB5015424) to learn more about what you need to consider before applying for a role. It is important for employees to self-assess that they meet the criteria before moving forward in the application process.​

Job Description:

The Specialist, Engineering, will be responsible for support of production of live virus vaccines within bulk vaccine production and/or final formulation and filling operations. This engineer will be a member of the Technical Services Deviation Management team in the Live Virus Vaccine Manufacturing End-to-End at the West Point site. The primary responsibility of the individual will be investigation initiation and closure associated with manufacturing deviations and development of actions in response to these deviations. Support will be focused on the Deviation Management process including operations support, equipment troubleshooting, implementation of process/ equipment actions, and other related duties. This position will require development of technical expertise of corresponding IPT operations. Limited off-shift or weekend coverage may be required based on business unit needs and specific assignments.

Responsibilities include:

+ Leads and/or works as a team member on manufacturing investigations and/or process improvement projects.

+ Has ability to examine an issue from diverse perspectives (safety, compliance, automation, equipment, process, and people) to best understand and resolve the root cause and implement actionable/effective CAPAs.

+ Assures consistent application of standardized work, engineering, and process tools.

+ Provides technical support to manufacturing shop floor for problems and issues.

+ Conducts and designs experimental protocols as needed using the Technical Operations lab facilities and/or production equipment at full scale.

+ Authors and updates technical and manufacturing documents necessary for investigations, process design/definition, engineering studies, process demonstrations, change control and validation.

+ Supports Internal/External Inspections as an SME

+ Provide project management support for various improvement and compliance projects

+ Present at and participate in key Tier meetings and Strategic Planning meetings

Minimum Education Requirements and Experience:

+ Bachelor of Science (B.S.) degree in Engineering or Sciences with 2 or more years’ experience in a GMP manufacturing and/or technical, operations, or quality support in GMP manufacturing operations; **OR**

+ Master of Science (M.S.) degree in Engineering or Sciences with 1 or more years’ experience in a GMP manufacturing and/or technical, operations, or quality support in GMP manufacturing operations

Required Experience and Skills:

+ Demonstrated ability to drive results

+ Strong communication, collaboration skills and ability to drive accountability

+ Strong problem-solving skillset

+ Deviation Management Experience (Quality Approver, QN Author, Technical Approver)

+ Technical Writing

+ Data Anallytics

+ Experience with SOP Management

Preferred Experience and Skills:

+ Vaccine manufacturing

+ Regulatory Inspection Experience

+ Sterile processing and Aseptic Gowning

+ Knowledge of Lyophilization processes

+ Quality Risk Assessment experience (in any capacity)

+ Live Virus Vaccine Experience (Drug Substance or Drug Product)

+ Environmental Monitoring and Process Simulation Experience

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 (https://survey.sogosurvey.com/r/aCdfqL) 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:

EEOC Know Your Rights (https://www.eeoc.gov/sites/default/files/2022-10/22-088\_EEOC\_KnowYourRights\_10\_20.pdf)

EEOC GINA Supplement​

Pay Transparency Nondiscrimination (https://www.dol.gov/sites/dolgov/files/OFCCP/pdf/pay-transp\_%20English\_formattedESQA508c.pdf)

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 (https://www.msdprivacy.com/us/en/CCPA-notice/)

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”.

Current Employees apply HERE (https://wd5.myworkday.com/msd/d/task/1422$6687.htmld)

Current Contingent Workers apply HERE (https://wd5.myworkday.com/msd/d/task/1422$4020.htmld)

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 (https://survey.sogosurvey.com/r/aCdfqL) if you need an accommodation during the application or hiring process.

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:

EEOC Know Your Rights (https://www.eeoc.gov/sites/default/files/2022-10/22-088\_EEOC\_KnowYourRights\_10\_20.pdf)

EEOC GINA Supplement​

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.

Learn more about your rights, including under California, Colorado and other US State Acts (https://www.msdprivacy.com/us/en/CCPA-notice/)

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:

Hybrid

Shift:

1st - Day

Valid Driving License:

No

Hazardous Material(s):

n/a

Required Skills:

Adaptability, Adaptability, Business Process Creation, Business Requirements Analysis, Change Control Management, Collective Bargaining, Data Analysis, Engineering Design, Engineering Process, Equipment Troubleshooting, GMP Compliance, Good Manufacturing Practices (GMP), Hardware Troubleshooting, Lean Manufacturing, Manufacturing Analytics, Manufacturing Support, Mechatronics, Operations Support, Personal Initiative, Process Improvement Projects, Process Methodologies, Process Optimization, Process Simulation, Process Troubleshooting, Production Process Development {+ 12 more}

Preferred Skills:

Job Posting End Date:

05/12/2025

*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:** R348724