Job Description

Our Engineers support 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 company is in the United States and Canada, is a global health care leader with a diversified portfolio of prescription medicines, vaccines and animal health products. The difference between potential and achievement lies in the spark that fuels innovation and inventiveness; this is the space where our company has codified its legacy for over a century. Our company's success is backed by ethical integrity, forward momentum, and an inspiring mission to achieve new milestones in global healthcare.

Our company's Manufacturing Division is a team of dedicated, energetic individuals who are committed to being the most trusted supplier of pharmaceuticals and health products worldwide. Our facilities, along with our external contractors, suppliers, and partners, comprise an interdependent global manufacturing network that’s committed to delivering a compliant, reliable supply to customers and patients on time, every time, across the globe.

The Change Control Engineer works closely with Production, Engineering, Technical Services, Quality, Stability, and Planning to align process changes supporting PAI Readiness activities, new product introductions, site optimizations, and marketing-driven initiatives. Recognized as a subject matter expert in Change Control functions making decisions based on policies, procedures, requirements, and guidelines.

Primary Duties include, but are not limited to:

• Serves as a site-level project manager to implement changes ranging from moderate to complex, high-priority, high-visibility launches with significant above-site/off-site involvement

• Coordinates internal and external resources for the flawless execution of projects delivered on-time by developing a detailed project plan tracking progress to completion

• Monitors Trace link database for supplier change control notifications and submit site-impacted changes to CRB meeting for PCR development.

• Serves as a site contact for multi-site supplier changes initiated in the Trace link database.

• Responsible for being a QMS Chapter sub-system owner and presenting associated metrics at Quality Council.

• Assumes ownership of PCR tasks or downstream impact identification for above-site driven changes.

• Represents PTO on development and commercialization teams as appropriate by interfacing with Regulatory, Marketing, Product Strategy Leaders, Global Labeling Operations and other internal or external customers on new and existing products introductions by ensuring products conform to regulatory and compliance obligations (e.g. FDA, EMA, DEA, cGMP, etc.)

• Submits Process Change Requests (PCRs) for change prioritization

• Providing business case to VCM Product Lead for the change to evaluate if the change fits within the product strategy

• Leads PCR sub-team meetings to establish requirements across multi-departmental areas in support of new product launches and/or technical transfers

• Initiates PCRs, assigns tasks to stakeholders, and tracks PCRs to closure to assure regulatory timelines for implementation are met and that product supply is not interrupted

• Conducts Annual Product Reviews of Product PCRs ensuring complete and accurate documentation is provided to Quality

• SOP author and/or reviewer for departmental related procedures

Required Education:

• High school diploma with seven (7)+ years of pharma manufacturing experience OR

• Bachelor’s degree with two (2)+ years of pharma manufacturing experience

Required Qualifications:

• Experience in validation or change control
• Extremely detailed in both written and verbal communications/documentation

• Must be able to organize and manage multiple projects that span different timelines

• Risk-based decision-making skills without knowledge of all the inputs

• Positive attitude, strong work ethic, ability to work under pressure, and be a fast learner

• Must be able to work in a Team-environment and collaborate cross-functionally

• Strong Microsoft Office Knowledge – especially Outlook, Excel, and Word

Preferred Qualifications:

• Experience with regulatory audits

• Project Management Professional Certification

• Microsoft Project experience

• Experience with GCM TrackWise, IPI, SAP, Trace link, Supplier Transparency

• Working knowledge of our company's policies & procedures, environmental, safety standards and guidelines, GMP's, governmental regulations (e.g. OSHA), industry and engineering standards

• Understanding of Supply Chain Management, particularly the flow of materials from suppliers and through the Wilson site

Current Employees apply HERE

Current Contingent Workers apply HERE

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.

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

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

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”.

The salary range for this role is

$85,600.00 - $134,800.00

This is the lowest to highest salary we in good faith believe we would pay for this role at the time of this posting. An employee’s position within the salary range will be based on several factors including, but not limited to relevant education, qualifications, certifications, experience, skills, geographic location, government requirements, and business or organizational needs.

The successful candidate will be eligible for annual bonus and long-term incentive, if applicable.

We offer a comprehensive package of benefits. Available benefits include medical, dental, vision healthcare and other insurance benefits (for employee and family), retirement benefits, including 401(k), paid holidays, vacation, and compassionate and sick days. More information about benefits is available at https://jobs.merck.com/us/en/compensation-and-benefits.

You can apply for this role through https://jobs.merck.com/us/en (or via the Workday Jobs Hub if you are a current employee). The application deadline for this position is stated on this posting.

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, Applied Engineering, Communication, Data Analysis, Engineering Standards, Leadership Training and Development, Management Process, Manufacturing Quality Control, Manufacturing Scale-Up, Packaging Engineering, Packaging Equipment, Packaging Processes, Packaging Testing, Process Design, Root Cause Analysis (RCA), Sealing Machines, Teamwork, Technical Writing

Preferred Skills:

Job Posting End Date:

09/18/2025

*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.