Process Engineer, Technical Operations - Small Molecule Drug Substance

Job Description

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

At our company, we aspire to be the premier research-intensive biopharmaceutical company, using the power of leading-edge science to save and improve lives around the world. We are at the forefront of research to deliver innovative health solutions that advance the prevention and treatment of diseases in people and animals.

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 deep 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

Provide technical support for API manufacturing processes, including: Chemical synthesis

Purification and isolation

Crystallization and drying operations

Take ownership of assigned process equipment and manufacturing processes

Support process scale-up, technology transfer, and validation activities (e.g. pre-PPQ, PPQ)

Analyze process data to support performance monitoring, troubleshooting, and improvement

Provide on-the-floor technical support during manufacturing campaigns

 

Technology Transfer & Commercialization

Support execution of technology transfers for new products and processes into the facility

Partner with global R&D and receiving 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 Optimization & Operational Excellence

Partner with Manufacturing to support safe, efficient, and reliable plant performance

Identify and implement improvements in process robustness, product quality, and plant performance

Support activities related to operational excellence and cost reduction

Contribute to cleaning and turnaround optimization activities

Assist in deviation investigations, root cause analysis, and implementation of CAPAs

Monitor process performance, yields, and cycle times to identify improvement opportunities

Drive or participate in continuous improvement initiatives focused on: Yield and throughput

Cycle time reduction

Cost and efficiency improvements

Compliance & Documentation

Ensure all activities are conducted in compliance with cGMP, safety, and environmental standards

Support campaign preparation, execution, and post-campaign review activities

Support batch record generation, review, and ongoing optimization

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

Participate in cross-functional teams supporting product introduction and lifecycle manage

Qualifications

To excel in this role, you will have:

Degree in Chemical Engineering, Chemistry, or related discipline

Typically 2–5+ years’ experience in API manufacturing, process development, or related pharmaceutical environment

(PhD may offset experience)

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 analyze 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

Our Culture

We keep the patient at the heart of everything we do and strive to deliver solutions for some of the world’s most challenging healthcare needs. We believe innovation happens when empowered individuals collaborate in an inclusive, high-performing environment.

So, if you are ready to:

Support delivery of new Drug Substance manufacturing capability

Develop your expertise in API processing and commercialization

Contribute to a high-impact, technology-driven manufacturing environment

…we encourage you to apply.

#ELKVACOE

Required Skills:

Adaptability, Adaptability, Biopharmaceutical Industry, Biopharmaceuticals, Biopharmaceutics, Change Control Management, Chemical Engineering, Continuous Process Improvement, Cross-Functional Collaboration, Data Analysis, Deviation Investigations, Equipment Troubleshooting, Good Manufacturing Practices (GMP), Lean Manufacturing, New Product Development, Operational Excellence, Performance Monitoring, Personal Initiative, Process Optimization, Professional Integrity, Project Management, Project Manufacturing, Root Cause Analysis (RCA), Teamwork, Technical Writing {+ 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.

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

The salary range for this role is

$87,300.00 - $137,400.00

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:

08/20/2026 *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.

Requisition ID:R405916