Specialist, Engineering - 2nd Shift (Onsite)

Merck•Rahway, NJ

7d•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). 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. The FLEx organization is seeking a highly motivated individual to serve the role of Specialist, Technical Operations Engineer, reporting to the Technical Operations Lead. The successful candidate will support routine operations through timely troubleshooting of production equipment issues 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 may be required occasionally to coordinate with personnel from first shift.

Requirements

BS or MS in Chemical Engineering, Mechanical Engineering, Biomedical Engineering or related engineering field with a minimum of 2 years of relevant experience.
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.
Prior experience with automated processing equipment.
Familiarity with common Drug Product processing unit operations such as mixing, filtration, temperature control and etc.
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

Strong working knowledge of 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 and change management.
Experience with Commissioning, Qualification and Validation of equipment.
Knowledge of Investigational drug regulatory requirements.
Understanding of Clinical Supply Chain Operations.

Responsibilities

Support routine operations through timely troubleshooting of production equipment issues
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