Job Description

We have an exciting opportunity for a Assoc. Process Engineer, Technical Operations - Drug Substance to join our growing team.

Join a purpose-built, agile small molecule manufacturing site where your work will help bring important medicines to patients in the U.S. This facility is designed to move quickly and reliably, receiving technology transfers from commercialization sites and fast-following into production with a focus on quality, safety, and operational excellence.

At our site, you'll be part of a team committed to creating a safe, environmentally responsible, and compliant workplace where people can do their best work. We are building deep small molecule expertise in the U.S., and we want team members who are excited to grow their skills, help improve how we operate, and contribute to a site positioned for future growth.

The successful candidate will provide technical support for the facility design, commissioning, qualification through technology transfer, validation and ongoing commercial manufacture of active pharmaceutical ingredients (APIs).

In this role, you will work as part of a cross-functional team, initially supporting the capital project and transitioning to technology transfer and commercial manufacturing, while building technical expertise and contributing to operational excellence.

Key Responsibilities

Technical & Process Support

• Support the Capital Project Team, contributing to design, commissioning, qualification, and startup readiness
• Knowledge and subject matter expertise on API processing unit operations and scale up opportunities are a core part of the role, with the ability to identify and overcome constraints and tests to ensure successful demonstration of processes through piloting and validation.

• Take ownership of assigned process equipment and manufacturing processes
• Support technology transfer, and validation activities (e.g. pre-PPQ, PPQ)
• Analyse process data to support performance monitoring, troubleshooting, and improvement
• Provide on-the-floor technical support during manufacturing campaigns

Technology Transfer & Commercialisation

• Support execution of technology transfers for new products and processes into the facility
• Partner with Commercialization and external sites to ensure effective process knowledge transfer
• Contribute to process fit assessments, scale-up readiness, and manufacturability evaluations
• Support development and review of batch documentation and process instructions
• Assist in integration of new technologies into manufacturing operations

Process Optimisation & Operational Excellence

• Identify and implement improvements in process robustness, product quality, and plant performance
• The successful candidate will have an aptitude for technical problem solving, with a background in solving technical issues to obtain a positive outcome.
• Contribute to cleaning and turnaround optimisation activities
• Assist in deviation investigations, root cause analysis, and implementation of CAPAs
• Monitor process performance, yields, and cycle times to identify improvement opportunities

Compliance & Documentation

• Ensure all activities are conducted in compliance with cGMP, safety, and environmental standards
• participation in campaign preparation, safety and environmental reviews, batch sheet reviews
• Support campaign preparation, execution, and post-campaign review activities
• Support batch record generation, review, and ongoing optimisation
• Assist in regulatory and inspection readiness activities
• Ensure accurate documentation of process knowledge, investigations, and improvements

Cross-functional Collaboration

• Work closely with Manufacturing, Quality, Engineering, Supply Chain, and R&D teams
• Provide technical input into projects, process changes, and ongoing operations
• The candidate will have excellent communication skills, with an aptitude of imparting and guiding complex projects across boundaries and an ability to convey and link with people at all levels of the organisation in a helpful, compliant manner.

Qualifications

To excel in this role, you will have:

• Bachelors Degree in Chemical or Process Engineering or related discipline

• Typically 1-4+ years' experience in API manufacturing, process development, or related pharmaceutical environment
• Exposure to API processing operations and scale-up
• Understanding of cGMP manufacturing and regulatory expectations

• Experience in one or more of:
  • Process support or development
  • Technology transfer
  • Manufacturing operations

Key Skills:

• Strong analytical and problem-solving capability
• Ability to analyse data and make sound technical decisions
• Effective communication and collaboration across cross-functional teams
• Ability to manage priorities, meet deadlines, and deliver quality outcomes
• Proactive, self-driven approach to continuous improvement

Required Skills:
Adaptability, Adaptability, Applied Mathematics, Biopharmaceutical Industry, Biopharmaceuticals, Biopharmaceutics, Chemical Engineering Fundamentals, Chemical Plant Operations, Cross-Functional Collaboration, Data Analysis, Deviation Investigations, Engineering Standards, Environmental Health And Safety, Estimation and Planning, Field Failure Analysis, Manufacturing Scale-Up, Operational Excellence, Oral Solid Dosage, Process Changes, Process Optimization, Professional Engineering, Project Manufacturing, Site Supervision, Teamwork, Technical Issues {+ 2 more}

Preferred Skills:

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.

The salary range for this role is
$71,900.00 - $113,200.00

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:
Domestic

VISA Sponsorship:
No

Travel Requirements:
10%

Flexible Work Arrangements:
Not Applicable

Shift:
1st - Day

Valid Driving License:
No

Hazardous Material(s):
NA

Job Posting End Date:
07/25/2026
*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.