Associate Specialist, Engineering (Onsite)

Merck • Rahway, NJ

3d • Onsite

About The Position

The Formulation, Laboratory, and Experimentation (FLEx) Center in Rahway, New Jersey, features a cutting-edge sterile drug product cGMP clinical supply manufacturing facility, known as FLEx Sterile. The FLEx Sterile facility is poised to play a pivotal role in the long-term success of delivering our clinical pipeline to patients worldwide, encompassing a range of product modalities, including sterile small molecules, biologics, vaccines, and antibody-drug conjugates (ADCs). A large-scale capital project, known as the FLEx Sterile Expansion project, is currently underway.
The FLEx Sterile Expansion project is nearing completion of its detailed design phase and has begun construction and commissioning and qualification of the long lead time process equipment. Upon its completion, the expansion project will more than double the capacity of the existing FLEx Sterile Facility by adding a second clinical filling/lyophilization suite, a formulation suite, a sterile supply suite, and various supporting infrastructure and utilities.
The Technical Operations – New Production Introduction (NPI) role at the Associate Specialist level will make significant contributions in technical transfer, manufacturing science and technology, startup and operational readiness activities and deliverables related to the expansion project. The successful candidate will play a crucial role in ensuring flawless execution of startup and operational readiness deliverables of the FLEx Sterile Expansion project, particularly those requiring subject matter expertise of from the voice of the process and business. This individual will collaborate closely with the formulation scientists, engineers, 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.
Once the facility is operational, this role will support the formulation, process development, and scale-up activities, quality investigations and change management, standard operating procedures and protocols in support of sterile clinical drug product operations.

Requirements

• Familiarity with United States and European Union GMP and Safety compliance regulations.
• Ability to prepare Standard Operating Procedures (SOP) and current GXP documents.
• 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.

Nice To Haves

• Ability to convert new drug product attributes and process needs to an executable series of steps and procedures to enable acceptable product manufacture.
• Knowledge of drug product aseptic processing, equipment and sterile technique.
• Experience in leading and supporting quality investigations and change management.
• Experience with sterile GMP facility startup.
• Experience with Commissioning, Qualification and Validation.
• Knowledge of Investigational drug regulatory requirements.
• Understanding of Clinical Supply Chain Operations.

Benefits

• 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.

What This Job Offers

• Job Type: Full-time
• Career Level: Entry Level