Sterile Process Engineer, Specialist (On-site)

MSD Malaysia

Rahway (NJ)

On-site

USD 30,000 - 36,000

Full time

2 days ago

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Job summary

Merck seeks a Specialist-level Sterile Process Engineer to drive sterile clinical drug product operations at the Rahway FLEx GMP facility. The role emphasizes leadership, process transfer, scale-up, investigations, and SOP/GXP documentation across cross-functional teams.

The candidate will collaborate with formulation scientists, operations staff, and quality representatives to ensure quality and speed of the pipeline while maintaining regulatory compliance.

Qualifications

Bachelor’s degree in Chemical Engineering, Chemistry, Pharmaceutical Sciences or related field with at least 3 years’ experience.
Master’s degree in Chemical Engineering, Chemistry, Pharmaceutical Sciences or related field expected by June 2027.

Responsibilities

Lead sterile process engineering efforts for GMP clinical manufacturing at the Rahway site.
Drive process tech transfer, scale-up activities, and quality investigations.
Manage change control and author SOPs and current GXP documents.
Collaborate with formulation scientists, operations, and QA to ensure quality and compliance.

Skills

Enterprise leadership

Interpersonal communication

Quality investigations

Change management

GMP/Safety compliance

Process transfer

SOPs & GXP documents

Quality systems

Organization

Independent problem solving

Education

Bachelor’s degree in Chemical Eng/ Chemistry/ Pharmaceutical Sciences or related field with 3+ years experience

Master’s degree in Chemical Eng/ Chemistry/ Pharmaceutical Sciences or related field (completion by Jun 2027)

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 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 support the pipeline’s most technically complex formulations and process development through process tech transfer, 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 formulation scientists, engineers, operations staff, 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 3 years relevant experience
Master’s degree in Chemical Engineering, Chemistry, Pharmaceutical Sciences or related scientific field (with expected completion no later than June 2027)

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 operations.
Knowledge of Investigational drug regulatory requirements.
Understanding of Clinical Supply Chain Operations.
Expertise in drug product aseptic processing, equipment, and sterile technique.

FLEx2026 Sterile2026 VETJOBS EligibleforERP Required Skills

Aseptic Processing
cGMP Guidelines
Electronic Batch Records
Laboratory Experiments
Pharmaceutical Regulatory Compliance
Pharmaceutical Sciences
Pilot Plant Operations
Process Engineering
Process Improvements
Standard Operating Procedure (SOP)
Sterile Manufacturing
Technology Transfer
Troubleshooting

Eligibility and Rights

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

Salary and Benefits

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.

Location and Work Arrangements

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

Resident Considerations

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

Job Posting End Date

Job Posting End Date: 09/25/2026