Job Description

The External Manufacturing Large Molecule Drug Product Technical Operations (ExM LM DP TO) organization is seeking a highly motivated individual for a Sr. Specialist Engineering position. ExM LM DP TO is accountable for technology transfers and commercial production of sterile drug product at our Company’s External Partners (EPs). This person will have the opportunity to lead activities in all these areas with a primary focus on commercial production.

Responsibilities include:

Work with External Partners to achieve business goals and to establish a common culture that benefits both our company, External Partners, and patients

Responsible for technical activities for the commercial manufacturing process at the External Partner, which includes authorship of change control, management of process improvement projects, statistical analysis of process performance, and investigation of atypical events

Responsible for technical transfer activities, as applicable, through authorship and/or review of required GMP documentation (Master Batch Records, change control, protocols, reports, qualifications, etc.) and regulatory filings.

Provide on-site coverage at External Partner in support of Commercial and / or Tech Transfer Person In Plant Activities

Translate understanding of GMP requirements and current regulations and develop standardized work to meet these requirements by partnering with Operations, Quality, and External Partners

Ensure that External Partners are inspection ready for all routine inspections and / or inspections related to new product introductions or transfers, in concert with Operations, Quality, and Regulatory

Responsible for participation in creating, sharing, and adopting best practices and business process strategies

Minimum Education Requirement and Experience:

Bachelors degree in chemical/Biochemical Engineering, Pharmaceutical Science, or Chemistry/Biology, or other related science or engineering field with four (4) years’ experience in a GMP functional area or support of a GMP functional area, such as Operations, Technical Operations, Technology, Engineering, and/or MaintenanceRequired Experience and Skills:

Travel will be a requirement of this position at approximately 25%

Strong communication and teamwork skills

Preferred Experience and Skills:

Experience in sterile / aseptic manufacturing

Demonstrated ability to independently manage projects/work to schedule/deadlines

Statistics experience

Experience in deviation management and/or change control and/or equipment support, and/or project management.

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 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

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

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:

25%

Flexible Work Arrangements:

Remote

Shift:

1st - Day

Valid Driving License:

No

Hazardous Material(s):

n/a

Job Posting End Date:

04/10/2025

*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: R342490