Sr. Specialist, Engineering (Onsite)

MSD; Rahway (NJ); On-site; USD 117,000 - 184,000; Full time

Job summary

MSD in Rahway, New Jersey seeks a Senior Specialist Sterile Process Engineer to drive process development, tech transfers, and quality investigations for sterile clinical drug products at the FLEx Center.

You will collaborate with development scientists, engineers, operations, and quality, author SOPs, and ensure regulatory compliance while supporting on-site manufacturing in New Jersey. This role reports to the Sterile Process Engineering Lead.

Qualifications

• Bachelor's degree or higher in a related scientific field with several years of relevant experience.
• Advanced degrees preferred for higher-level responsibilities.
• Experience leading sterile GMP-related activities is desirable.

Responsibilities

• Lead process transfers and scale-up activities for sterile clinical drug products.
• Drive investigations and change management to ensure compliant operations.
• Author and maintain SOPs and GXP documents for sterile operations.
• Collaborate with development scientists, engineers, operations, and quality to ensure product quality and process rigor.
• Report to Sterile Process Engineering Lead and support on-site facility operations in Rahway, NJ.

Skills

Leadership

Communication

Quality investigations

Change management

GMP compliance

SOP writing

Process development

Problem solving

Regulatory knowledge

Education

Bachelor's degree in Chemical Eng / Chemistry / Pharmaceutical Sciences

Master's degree in Chemical Eng / Chemistry / Pharmaceutical Sciences

PhD in Chemical Eng / Chemistry / Pharmaceutical Sciences

Job description

Job Description

The Formulation, Laboratory, and Experimentation (FLEx) Center is a new multi-modality (small molecule, biologics, vaccine) Drug Product development and Good Manufacturing Practice (GMP) clinical supply manufacturing facility in Rahway, New Jersey.

The Sterile Process Engineer role at the Senior Specialist level will leverage the individual’s leadership, technical, and communication skillsets to drive the success of our clinical manufacturing facility and organization.

This role will directly support the pipeline’s most technically complex formulations and process development through process tech transfers, scale-up activities, quality investigations, change management, and authoring GMP standard operating procedures and protocols in support of sterile clinical drug product operations. This individual will collaborate closely with the development scientists, engineers, operations, quality representatives, and other team members to ensure the quality of the clinical supplies, the scientific rigor of the processes, and ultimately to enable the flexibility and speed of our Company’s pipeline. The role is, on-site, based in New Jersey and reports to the Sterile Process Engineering Lead of the FLEx GMP facility within Pharmaceutical Operations and Device Development (PSDD).

Education Minimum Requirements

• Bachelor’s degree in Chemical Engineering, Chemistry, Pharmaceutical Sciences or related scientific field with a minimum of 5 years relevant experience
• Master’s degree in Chemical Engineering, Chemistry, Pharmaceutical Sciences or related scientific field with a minimum of 3 years of relevant experience, or a
• PhD degree in Chemical Engineering, Chemistry, Pharmaceutical Sciences or related scientific field with a minimum of years of relevant experience.

Required Experience and Skills

• Excellent enterprise leadership skill demonstration
• Excellent interpersonal and communication skills, both verbal and written.
• Experience in leading quality investigations and change management.
• Familiarity with United States and European Union GMP and Safety compliance regulations.
• Ability to convert new drug product attributes and process needs to an executable series of steps and procedures to enable acceptable product manufacture.
• Ability to prepare Standard Operating Procedures (SOP) and current GXP documents.
• Experience with quality systems.
• Excellent organizational skills.
• Desire and willingness to learn, contribute and lead.
• Track-record of independent problem-solving.

Preferred Experience and Skills

• Experience with sterile GMP facility startup.
• Knowledge of Investigational drug regulatory requirements.
• Understanding of Clinical Supply Chain Operations.
• Expertise in drug product aseptic processing, equipment, and sterile technique.

Required Skills

Adaptability, Adaptability, Analytical Testing, Change Management, Chemical Engineering, Clinical Trials Operations, Data Analysis, Detail-Oriented, Deviation Management, Equipment Qualification, GMP Compliance, Good Manufacturing Practices (GMP), Medical Supply Management, Medicinal Chemistry, Pharmaceutical Sciences, Process Design, Process Hazard Analysis (PHA), Process Optimization, Root Cause Analysis (RCA), Standard Operating Procedure (SOP), Standard Operating Procedure (SOP) Development, Sterile Procedures, Strategic Thinking, Technical Leadership, Technical Problem-Solving {+ 1 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.

Equal Employment Opportunity Employer

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, Learn more about your rights, including under California, Colorado and other US State Acts

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.

Salary Range

$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

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

1st - Day

Valid Driving License

No

Hazardous Material(s)

n/a

Job Posting End Date

09/1/2026

*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.