Associate Specialist, Process Engineer - Oral Solid Dosage, Clinical Manufacturing (Onsite)

Merck & Co.; Rahway (NJ); On-site; USD 72,000 - 113,000; Full time

Benefits offered by this job

Medical, dental, vision

401(k) retirement

Paid holidays, vacation, sick days

Job summary

Merck & Co. in Rahway, New Jersey, seeks an Associate Specialist - Process Engineer to lead clinical supply manufacturing, ensure GxP compliance, and drive on-the-floor batch production.

You will draft batch records, qualify equipment, support MES and electronic batch records, and collaborate across formulators, engineers, safety and quality to accelerate our pipeline.

Qualifications

• Experience executing GxP manufacturing in pilot plant environment.
• Experience with electronic batch records and MES systems.
• Knowledge of drug product processing.
• Desire and willingness to learn and contribute through independent problem-solving.
• Experience in leading and supporting quality investigations and change management.

Responsibilities

• Lead on-the-floor batch manufacturing to ensure safety and quality of clinical supplies.
• Draft and execute GxP documentation including batch records, equipment qualification and cleaning, change records and deviations.
• Build partnerships by developing relationships within and across formulators, engineers, safety and quality reps.
• Foster culture of collaboration, learning and innovation.

Skills

GMP Compliance

Process Control

Process Optimization

Scale-Up

Teamwork

Lean Manufacturing

Quality Control

Estimation & Planning

Engineering Standards

Driving Continuous Improvement

Education

Associate's degree in chemical engineering, Chemistry, Pharmaceutical Sciences or related field

Bachelor's in chemical engineering, Chemistry, Pharmaceutical Sciences or related scientific field

Master's in chemical engineering, Chemistry, Pharmaceutical Sciences or related scientific field

Tools

MES systems

Job description

Job Description

The Formulation, Laboratory, and Experimentation (FLEx) Center is a multi-modality (small molecule, biologics, vaccine) Drug Product development and clinical manufacturing facility in Rahway, New Jersey.- This team works with non-sterile formulations, typically oral solid dosage (blending, roller compaction, encapsulation, tableting) including spray dried intermediates, liquid suspension/bottle fills, and autoinjector assembly. We are part of the research division, focusing on development and clinical deliveries in a GMP piloting facility supporting our Company's research division.

The Oral Solids Dosage (Non-Sterile) team at the FLEx Center in Rahway is looking for an Associate Specialist - Process Engineer to lead clinical supply manufacturing, scientific rigor of processes, and ultimately to enable flexibility and speed of our Company's pipeline.

This person will:

• Lead on-the-floor batch manufacturing to ensure safety and quality of clinical supplies to augment and accelerate our products.
• Draft and execute GxP documentation including but not limited to batch records, equipment qualification and cleaning, change records and deviations.
• Build partnerships by developing and leveraging relationships within and across work groups of formulators, engineers, safety and quality representatives.
• Foster culture of collaboration, learning and innovation.

Required Experience and Skills:

• Experience executing GxP manufacturing in pilot plant environment.
• Experience of interest in supporting electronic batch records and MES systems.
• Knowledge and experience of drug product processing.
• Desire and willingness to learn and contribute through independent problem-solving.
• Experience in leading and supporting quality investigations and change management.

Education Minimum Requirements:

• Associate's degree in chemical engineering, Chemistry, Pharmaceutical Sciences or related field with a minimum of 3 years relevant experience
• Bachelor's in chemical engineering, Chemistry, Pharmaceutical Sciences or related scientific field.
• Master's degree in chemical engineering, Chemistry, Pharmaceutical Sciences or related scientific field

Preferred Experience and Skills:

• Knowledge of Investigational drug regulatory requirements
• Understanding of Clinical Supply Chain Operations
• Experience with Commissioning, Qualification and Validation
• Experience with spray dried intermediates and/or hot melt extrusion

Required Skills:

Driving Continuous Improvement, Engineering Standards, Equipment Qualification, Estimation and Planning, GMP Compliance, GMP Validation, Lean Manufacturing, Manufacturing Quality Control, Manufacturing Scale-Up, Process Control, Process Optimization, Teamwork

Our company is committed to inclusion, ensuring that candidates can engage in a hiring process that exhibits their true capabilities.

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 primary location for this posting is:

USA - New Jersey - Rahway

Where required by law, the compensation range for this role is provided below.

The salary range for the primary location of this role is:

$71,900.00 - $113,200.00

This range reflects the Company's reasonable expectation of the base salary applicable to this role at the time of 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 .

Additional location(s):

Please note the salary range above applies to the Primary Location of the position. Where a role has other listed locations, different compensation guidelines may apply. You may find the salary ranges for additional locations below. If the salary range is not listed for the location you are applying to, our Talent Acquisition team will provide further information to you relevant to your location.

Additional location(s) Compensation Information:

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

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):

Acetone, Iso-Propyl Alcohol

Job Posting End Date:

11/6/2026

*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:

R423989