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

1000 Merck Sharp & Dohme LLC; Rahway (NJ); On-site; USD 72,000 - 113,000; Full time

Job summary

Merck & Co., Inc. in Rahway, NJ is seeking an Associate Specialist – Process Engineer to lead clinical supply manufacturing in the FLEx Center. You will drive on-the-floor batch production, ensuring safety, quality, and regulatory compliance for non-sterile oral solids.

Collaborate with formulators, engineers, and QA to draft GxP documents, support equipment qualification, and investigate deviations. This role emphasizes problem solving, cross-functional teamwork, and continuous improvement in a

Qualifications

• Experience executing GxP manufacturing in pilot plant environment.
• Experience with electronic batch records and MES systems.
• Knowledge of drug product processing.
• Willingness to learn and contribute through independent problem-solving.
• Experience with 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 and leveraging relationships within and across work groups of formulators, engineers, safety and quality representatives.
• Foster culture of collaboration, learning and innovation.

Skills

GxP manufacturing

Pilot plant

Electronic batch records

MES systems

Drug product processing

Education

Associate degree in chemical engineering or related

Bachelor's in chemical engineering, Chemistry or related

Master's in chemical engineering or related

Tools

MES software

Job description

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

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.

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.

Search Firm Representatives

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): Acetone, Iso-Propyl Alcohol

Our company 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 we have codified our legacy for over a century. Our success is backed by ethical integrity, forward momentum, and an inspiring mission to achieve new milestones in global healthcare.