Job Description

The function of this position is to provide engineering technical support to the manufacture of liquid vaccines. The role encompasses technical services support in the areas of deviation management, equipment and automation systems, validation, and product franchise. Specific assignments may be focused in one area or span across multiple areas of focus.

Position Responsibilities:

• Serve as a subject matter expert for the Deviation Management team. Support and perform deviation investigations aimed to prevent deviation re-occurrence, including determining the root cause, identifying corrective/preventative actions, identifying event scope, and conducting a product impact assessment. Where applicable, complete investigational test protocols to determine root cause, product impact, event scope, etc.

• Provide on-the-floor support of operational and technical issues; collaborating with the shop floor to aid in equipment, automation or process troubleshooting or to provide immediate responses to deviations and potential deviations.

• Conduct real time investigations with the goal of fully understanding root cause and product impact

• Manage projects to improve the performance of our processes, including projects aimed at improving Right-First-Time performance or preventing/reducing deviations, improve yield, reduce cost, or lower our processing cycle times

• Manage investigation and project timelines to ensure key compliance and customer due dates are met; escalating any potential misses and develop remediation plans when possible including change control.

• Support requests for regulatory inspections related to process overviews, investigations, projects, and validation.

• Author updates to Master Batch Records and Standard Operating Procedures

• Support team safety, environmental, and compliance objectives

• Collaborate effectively with the area Managers, Operators/Technicians, support groups (e.g. EMU, Automation, Quality, and Planning).

• Actively use and champion the use of Lean Six Sigma (LSS), our Company Production System, and digital tools both in problem solving and day-to-day operational activities.

Minimum Education Requirement and Experience:

• Bachelor of Science (B.S.) in Mechanical or Chemical Engineering Degree or similar discipline with five (5) years’ experience in support of Production, Process Engineering, Validation, Technical Services, or related experience; OR

• Master of Science (M.S.) in Mechanical or Chemical Engineering Degree or similar discipline with three (3) years’ experience in support of Production, Process Engineering, Validation, Technical Services, or related experience

Required Experience and Skills:

• Minimum of 1-year experience in Deviation Management

• Demonstrated ability to work both independently and as a part of a team.

• Experience with regulatory agency interactions

• Demonstrated leadership and teamwork skills, excellent analytical abilities, established written and verbal communication skills

Preferred Experience and Skills:

• Hands-on technical services experience in supporting formulation and filling, including manufacturing-scale filling isolators and closed system processing

• Experience with troubleshooting equipment and closed system processing

• Experience with MIDAS, MEDs, SAP, PI, DeltaV, ProCal, TrackWise

• LSS/MPS certification/experience

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.

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/)

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:

Domestic

VISA Sponsorship:

No

Travel Requirements:

No Travel Required

Flexible Work Arrangements:

Not Applicable

Shift:

1st - Day

Valid Driving License:

No

Hazardous Material(s):

n/a

Job Posting End Date:

12/26/2024

*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: R326815