Sr. Specialist, Engineering (Onsite)
MSD Malaysia
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Benefits offered by this job
Job summary
Merck is seeking a Sterile Process Engineer (Senior Specialist) for its FLEx Center in Rahway, NJ. You will lead process transfers, scale-up activities, and quality investigations to ensure robust sterile clinical drug product operations.
You will author GMP SOPs and GXP documents while collaborating with scientists, engineers, operations, and QA teams. The role requires advanced degrees in chemical engineering or pharmaceutical sciences and proven leadership with experience in sterile
Qualifications
- 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
- a PhD degree in Chemical Engineering, Chemistry, Pharmaceutical Sciences or related scientific field with a minimum of years of relevant experience
Responsibilities
- Drive sterile clinical drug product operations ensuring quality of clinical supplies
- Lead process transfers, scale-up activities and quality investigations
- Author GMP SOPs and current GXP documents
- Collaborate with development scientists, engineers, operations, and quality
- Ensure compliance with US/EU GMP and safety regulations
- Prepare and maintain robust documentation for regulatory readiness
- Lead continuous improvement and problem solving in manufacturing
Skills
Education
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).
- 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
- a PhD degree in Chemical Engineering, Chemistry, Pharmaceutical Sciences or related scientific field with a minimum of years of relevant experience
- 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.
- 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.
- 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}
- 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 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.
- medical
- dental
- vision healthcare and other insurance benefits (for employee and family)
- retirement benefits, including 401(k)
- paid holidays
- vacation
- compassionate and sick days
More information about benefits is available at https://jobs.merck.com/us/en/compensation-and-benefits.
The application deadline for this position is stated on this posting.
We will consider qualified applicants with arrest and conviction records for employment in compliance with the San Francisco Fair Chance Ordinance.
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.
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.
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