Associate Specialist, Engineering

MSD Malaysia; Rahway (NJ); On-site; USD 72,000 - 113,000; Full time

Job summary

Merck Rahway, NJ is seeking an Associate Specialist – Process/Facility Engineer to join the MACS Operations team in a fast-paced, technically demanding environment focused on drug substance scale-up and GMP manufacturing.

You will contribute to equipment and facility design, system commissioning/qualification, and startup activities, coordinating with Process R&D, Analytical, Quality, Safety and cross-functional groups to enable rapid, compliant production.

Qualifications

• Bachelor’s degree in Chemical Engineering, Chemistry, Biology, Pharmaceutical Sciences or related scientific field.
• Strong communication and teamwork abilities across cross-functional teams.
• Proven problem-solving skills and a proactive work approach.

Responsibilities

• Support MACS Center as a process team member for small molecule and bioconjugate programs.
• Assist in equipment and facility design, commissioning and qualification activities.
• Support startup activities and ensure GMP-compliant operations and documentation.
• Collaborate with Process R&D, Analytical, Quality and Safety to enable scalable manufacturing.

Skills

Interpersonal skills

Verbal and written communication

Organizational skills

Willingness to learn

Independent problem solving

Collaborative mindset

Mechanical aptitude

Technical writing

Education

Bachelor’s degree in Chemical Engineering, Chemistry, Biology, Pharmaceutical Sciences or related scientific field

Job description

Job Description Associate Specialist – MACS Process/Facility Engineer Description The Modality Agnostic Chemistry Scaleup (MACS) Operations group within the Chemical Engineering Research & Development (CERD) Department is seeking a highly motivated individual to work in a fast-paced job that provides a high degree of technical and project management responsibility.

The Associate Specialist – Process/Facility Engineering position will report to an Associate Director, Engineering as a member of the MACS Operations Team at the Rahway NJ facility.

Responsibilities of the Associate Specialist – Process/Facility Engineer include the following: The process engineer role at the Associate Specialist level will serve as a process team member supporting the Modality Agnostic Chemistry Scaleup (MACS) Center. This is a new potent, multi-modality (small molecule, macrocyclic peptides, bioconjugates) Drug Substance development and GMP clinical manufacturing plant currently planned in Rahway, New Jersey.

The Associate Specialist will work alongside their peers in the MACS Operations Team, with the Enabling Facilities group and other operations areas such as the SSO and Prep Lab (see below), as well as key stakeholders in Process R&D, Analytical, Quality, and Safety. They will be instrumental in setting up this first-of-a-kind facility by the ready for science target date of 2Q 2027.

As the MACS facility is currently under construction, the selected candidate will contribute to equipment and facility design, system commissioning/qualification, as well as other critical activity workstreams to enable facility startup and subsequent batch processing.

The selected candidate is expected to be a key part of a team of process/facility engineers, supervisors, and operations specialists to drive the work and foster a culture of collaboration, learning and innovation.

They will collaborate closely with the development engineers & chemists, compliance and safety representatives, and other team members to ensure the quality and safe delivery of clinical supplies, the scientific rigor of the processes, and ultimately to enable flexibility and speed of the Company’s pipeline.

This role may support facility operations, process development activities, support compliance investigations/change management, author GMP documentation and manage/lead engineers in any of our enabling facilities.

Additional Supported Areas:

Small Scale Organics Pilot Plant (SSO):

The SSO is a Good Manufacturing Practice (GMP) manufacturing facility in the Process Research and Development (PR&D) organization. The pilot plant’s mission is to serve as PR&D’s internal node for small molecule drug substance clinical manufacture, and as preferred site for first pilot of commercial small molecule processes, enabling gain of critical internal experience with scale-up of manufacturing GMP steps, demonstration of new manufacturing technology/processes, training opportunities for improved manufacturing process development and seamless tech transfer to commercial sites.

Prep Lab Area:

The Prep Lab is used to generate data which contributes to process definition and provides Phase I/II clinical material when needed. This kilo scale capability establishes reaction parameters and ensures successful batches when transferring to pilot scale. Areas of the Prep Lab have been and are continuing to be upgraded to support pipeline programs such as ADCs, PDCs, and other cross modality compounds that require a more flexible potent compound processing space.

Education Minimum Requirement:

Bachelor’s degree in Chemical Engineering, Chemistry, Biology, Pharmaceutical Sciences or related scientific field.

Required Experience and Skills:

• Effective interpersonal and communication skills, both verbal and written.
• Excellent organizational skills to multi-task.
• Desire and willingness to learn, contribute and lead.
• Track-record of independent problem-solving.
• Strong communication skills to discuss technical problems and a collaborative mindset to interface with cross-functional teams.
• A strong mechanical aptitude.
• Proficiency in technical writing and the use of word processing, spreadsheet, graphing, and presentation software.

Desired Experience and Skills:

• Working in a GMP clinical or manufacturing supply facility.
• GMP facility design, equipment start-up and/or qualification.
• Small molecule drug substance and/or biologics process development.
• Supporting compliance investigations and change management.
• Familiarity with US and EU GMP and Safety compliance regulations Ability to convert new drug substance process needs to an executable series of steps and procedures to enable acceptable product manufacture.
• Ability to prepare Standard Operating Procedures (SOP) and cGMP documents.
• Operating/maintaining pilot scale or prep lab scale equipment.
• Process Hazard Analysis (PHA) and/or Level of Protection Analysis (LOPA).
• Providing technical mentorship.
• Potent Compound processing and containment systems (e.g., isolators).
• Quality systems.
• Interacting with or overseeing the management of process utility system associated with a large drug substance pilot plant including WFI generation/distribution, Process Chillers, Vacuum Systems, etc.
• Working in an environment with an Automation System (DeltaV, PLC, etc.).
• Coordinating maintenance activities around processing activities to support reliable facility operation.

Required Skills:

• Chemical Engineering, Facility Engineering, GMP Compliance, Manufacturing Scale-Up, Pilot Projects, Process Engineering, Process Manufacturing, Process Scale Up, Standard Operating Procedure (SOP)

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 Compensation:

The salary range for this role is $71,900.00 - $113,200.00 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.

Benefits:

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.

Application Deadline:

The application deadline for this position is stated on this posting.

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.