Senior Specialist, Engineering (Onsite)

Merck•Rahway, NJ

8d•$117,000 - $184,200•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 diverse range of product modalities, including sterile small molecules, biologics, vaccines, and antibody-drug conjugates (ADCs). The FLEx organization has a mission to enable development of our Company’s pipeline products with speed, agility, and rigor. This mission will be accomplished by: 1) Enabling robust formulation and process development with flexible physical and digital infrastructure; 2) Delivering compliant, high quality clinical supplies; 3) Developing talents with a new operating model and promoting a growth mindset. As the facility just completed its Process Simulation execution and is officially released for clinical manufacturing, this presents an exciting opportunity for individuals eager to learn, demonstrate themselves, and grow with a rapidly expanding team. The FLEx organization is seeking a highly motivated individual to serve the role of Senior Specialist, Technical Operations Engineer, reporting to the Technical Operations Engineering Lead. The successful candidate will support routine operations through timely troubleshooting and resolution of production equipment issues, establishment of new processes and implementation of continuous improvement projects with goals to reduce operation cycle time, errors, and costs. This individual will collaborate closely with the Production, New Product Introduction, Facilities, Equipment, Automation and Quality teams to ensure compliant, right first-time execution and timely delivery of business goals. The role is on-site, based in Rahway, NJ and will support our first shift operations. To ensure continuity of operations, occasional second-shift coverage may be required to support the second-shift team during periods of absence. Occasional weekend support may also be necessary based on business and operational needs.

Requirements

BS or MS in Chemical Engineering, Mechanical Engineering, Biomedical Engineering or related engineering field with a minimum of 5 years of relevant experience.
Subject Matter Expertise in various sterile processing equipment such as automated filling lines, lyophilizers, autoclaves, part washers, isolators and etc.
Knowledge of automation systems such as PLC, DCS, and MES.
Knowledge of Drug Product aseptic processing techniques.
Experience in leading and supporting quality deviation investigations and change management.
Familiarity with United States and European Union GMP and Safety compliance regulations.
Ability to prepare Standard Operating Procedures (SOP) and current GXP documents.
Strong technical aptitude and critical thinking skills to effectively troubleshoot and resolve issues on the production floor.
Demonstrated project management experience leading cross-functional initiatives from planning through execution, with a proven ability to manage scope, timelines, risks, and stakeholder expectations.
Possess and leverages strong working knowledge of theories, practices, and procedures to train others efficiently. Applies knowledge to improve processes.
Familiarity with common Drug Product processing unit operations such as mixing, filtration, temperature control and etc.
Lean Six Sigma Green Belt certification.
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

Experience providing technical mentorship to engineers and cross-functional team members, including guidance on problem-solving, project execution, and professional development.
Experience with Commissioning, Qualification and Validation of equipment.
Understanding of ISA88 and ISA95 principles.
Knowledge of Investigational drug regulatory requirements.
Understanding of Clinical Supply Chain Operations.
Lean Six Sigma Black Belt certification.

Responsibilities

Support routine operations through timely troubleshooting and resolution of production equipment issues.
Establish new processes and implement continuous improvement projects with goals to reduce operation cycle time, errors, and costs.
Collaborate closely with the Production, New Product Introduction, Facilities, Equipment, Automation and Quality teams to ensure compliant, right first-time execution and timely delivery of business goals.
Provide technical mentorship to engineers and cross-functional team members, including guidance on problem-solving, project execution, and professional development.
Lead and support quality deviation investigations and change management.
Prepare Standard Operating Procedures (SOP) and current GXP documents.
Troubleshoot and resolve issues on the production floor.
Lead cross-functional initiatives from planning through execution, managing scope, timelines, risks, and stakeholder expectations.
Train others efficiently and apply knowledge to improve processes.
Perform Commissioning, Qualification and Validation of equipment.