Senior Process Engineer, Technical Operations – Small Molecule Drug Product (Oral Solid Dose)

Job Description

We have an exciting opportunity for a Senior Process Engineer, Technical Operations – Small Molecule Drug Product (Oral Solid Dose) 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 leadership and process ownership supporting facility design, commissioning, qualification, and startup through to technology transfer, validation, and ongoing commercial manufacture of oral solid dosage forms.

In this role, you will work as a key member of a cross-functional team, initially supporting the capital project and transitioning into process lead responsibilities across technology transfer and commercial manufacturing, driving technical excellence and operational performance.

Key Responsibilities

Technical & Process Leadership

Provide technical leadership for oral solid dose manufacturing processes, including:

Blending and granulation (where applicable)

Roller compaction (dry granulation)

Tablet compression

Film coating and finishing operations

Act as process owner / SME for assigned unit operations, equipment, or product processes

Provide technical input to the Capital Project Team, supporting:

Equipment selection and design reviews

Commissioning and qualification (CQV)

Startup readiness for OSD manufacturing lines

Lead or coordinate process scale-up, technology transfer, and validation activities (e.g. process performance qualification – PPQ)

Analyze and interpret process and product data (e.g. blend uniformity, tablet properties, coating performance) to drive data-driven decision-making and performance improvements

Provide advanced troubleshooting support for compression, compaction, and coating issues (e.g. weight variability, hardness, sticking/picking, coating defects)

Technology Transfer & Commercialization

Lead or play a key role in execution of technology transfers for oral solid dose products into the facility

Partner with global R&D and network sites to ensure robust transfer of formulation and process knowledge

Drive:

Process fit assessments

Scale-up strategy from development to commercial scale

Equipment capability and process comparability assessments

Own or guide development and optimization of:

Master batch records (MBRs)

Process descriptions and control strategies

Support integration and industrialization of new formulations and technologies (e.g. continuous manufacturing, advanced granulation approaches where applicable)

Process Optimization & Operational Excellence

Partner with Manufacturing to ensure safe, efficient, and reliable OSD plant performance

Identify, prioritize, and implement improvements in:

Content uniformity and tablet quality

Process robustness (e.g. compaction consistency, compression stability)

Yield, throughput, and cycle time

Lead or drive continuous improvement initiatives aligned with operational excellence

Use structured problem-solving approaches (e.g. RCA, DOE where applicable) to resolve:

Compression issues (e.g. capping, lamination)

Compaction variability

Coating defects (e.g. color variation, twinning, roughness)

Monitor process trends and product quality attributes to proactively identify risks and opportunities

Contribute to line optimization, changeover reduction, and debottlenecking activities

Compliance & Documentation

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

Provide technical leadership in campaign preparation, execution, and post-campaign review

Own and approve batch record updates, process specifications and control strategies

Support regulatory inspections and audits, providing technical input and ensuring inspection readiness

Ensure high standards of data integrity and technical documentation

Cross-functional Collaboration & Influence

Act as a technical representative across Manufacturing, Quality, Engineering, Supply Chain, and R&D

Provide clear technical direction and influence decision-making across product introductions and commercial operations

Lead or contribute to cross-functional initiatives, ensuring alignment to timelines and site objectives

Support knowledge sharing and best practice transfer across internal and external networks

Qualifications

To excel in this role, you will have:

Degree in Chemical Engineering, Pharmaceutics, Pharmaceutical Sciences, or related discipline

Typically 5+ years’ experience in oral solid dose manufacturing, formulation, or process development

(PhD may offset experience)

Strong experience in OSD manufacturing operations, particularly:

Roller compaction (dry granulation)

Tablet compression

Film coating processes

Experience in process scale-up and commercialization of solid oral dosage forms

Demonstrated involvement in:

Technology transfer

Process validation (PPQ)

Manufacturing support

Good understanding of cGMP manufacturing and regulatory expectations

Experience troubleshooting tableting and coating processes in a commercial environment

Key Skills:

Strong analytical capability with ability to interpret process and product performance data

Demonstrated ability to lead technical workstreams or projects

Excellent problem-solving skills with structured, science-based approach

Effective communicator with ability to influence cross-functional stakeholders

Proven ability to manage multiple priorities in a dynamic manufacturing environment

Proactive, self-driven mindset with strong focus on continuous improvement and ownership

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:

Play a key role in delivering oral solid dose manufacturing capability

Take ownership of formulation and process performance at commercial scale

Develop as a technical leader in a high-impact manufacturing environment

…we encourage you to apply.

#ELKVACOE

Required Skills:

Adaptability, Biopharmaceutical Industry, Change Control Processes, Chemical Engineering, Customer-Oriented, Deviation Management, Engineering Standards, Equipment Selection, Good Manufacturing Practices (GMP), Maintenance Engineering, Manufacturing Process Validation, Operational Excellence, Oral Solid Dosage, Pharmaceutical Sciences, Process Optimization, Regulatory Compliance, Root Cause Analysis (RCA), Strategic Thinking, Teamwork, Technical Leadership, Technical Support, Technical Transfer, Technology Transfer, Vibratory Rollers

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

$117,000.00 - $184,200.00

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:

Not Indicated

Valid Driving License:

No

Hazardous Material(s):

n/a

Job Posting End Date:

08/15/2026 *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:R407468