Sr. Spclst, Engineering (2nd Shift) - Onsite

Merck•Rahway, NJ

2d•Onsite

About The Position

Job Description: 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 nears completion of its Process Simulation execution, 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 Lead. The successful candidate will support routine operations through timely troubleshooting 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 second shift operations which operate from 3:30 PM EST to 12AM EST. Due to the nature of second shift operations, flexibility and overtime may be required occasionally to coordinate with personnel from first shift. Occasional weekend work may also be required to support operations.

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 processing aseptic processing techniques.
Experience in leading and supporting quality investigations of deviations 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.
Possesses effective project management skills to drive process improvement. Able to communicate clearly business/compliance driver, develop and manage project plan to meet deliverables, and escalate issues with meeting objectives to avoid schedule impact.
Strong technical aptitude and critical thinking skills to effectively troubleshoot and resolve issues on the production floor.
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. Able to cultivate and leverage working relationships with stakeholders within department as well as across the organization.
Excellent organizational skills to multi-task.
Desire and willingness to learn, contribute and lead.
Track-record of independent problem-solving.

Nice To Haves

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 of production equipment issues
Establish new processes and implementation of 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