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., Union Beach, NJOn-Site Research Chemistry Visionary Innovation Collections Scale (Map) Food Science Distillation Wet Chemistry Detail Oriented Beverage Products Technical Management Laboratory Equipment Artificial Intelligence Engineering Design Process Good Laboratory Practice (GLP) Gas Chromatography Mass Spectrometry High-Performance Liquid Chromatography +0 Rental Agent Aston Carter Woodbridge, NJOn-Site Filing Finance Operations Data Entry Accounting Procurement Real Estate Spreadsheets Supply Chain Communication Certified Mail Detail Oriented Microsoft Excel Lease Contracts Customer Service Microsoft Outlook Property Management Administrative Support Artificial Intelligence Administrative Functions

Automation Mentorship Innovation Autoclaves Compassion Supply Chain Communication Self-Motivation Problem Solving Small Molecules Scope Management Telephone Skills Technical Acumen Critical Thinking Change Management Growth Mindedness Biopharmaceuticals Project Management Strategic Thinking Analytical Testing Process Simulation Sterile Processing Automation Systems Root Cause Analysis Process Improvement Process Development Cycle Time Variation Contingent Workforce Process Optimization Willingness To Learn Chemical Engineering Six Sigma Green Belt Production Equipment Six Sigma Black Belt Deviation Management Six Sigma Methodology Organizational Skills Mechanical Engineering Project Implementation Biomedical Engineering New Product Development Process Hazard Analysis Deviation Investigations Distributed Control Systems Standard Operating Procedure Good Manufacturing Practices Continuous Improvement Process Troubleshooting (Problem Solving), * 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.

Preferred Experience and Skills:

• 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.

eligibleforERP, Analytical Testing, Change Management, Chemical Engineering, Chemical Technology, Deviation Management, Equipment Qualification, GMP Compliance, Good Manufacturing Practices (GMP), Process Hazard Analysis (PHA), Process Improvements, Process Optimization, Root Cause Analysis (RCA), Six Sigma, Strategic Thinking, Technical Problem-Solving, Data Analysis

Data Security Detail Oriented Microsoft Excel Risk Management Compliance Risk Microsoft Office Ad Hoc Reporting Data Warehousing Analytical Skills Quality Assurance Loan Documentation Workflow Management Microsoft PowerPoint Credit Risk Management Business Administration Web Application Security Document Management Systems Standard Operating Procedure Ethical Standards And Conduct Customer Relationship Management +0

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.

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The salary range for this role is $117,000.00 - $184,200.00

Merck & Co., Inc., Rahway, NJ, USA, also known as Merck Sharp & Dohme LLC, Rahway, NJ, USA, does not accept unsolicited assistance from search firms for employment opportunities. All CVs / resumes submitted by search firms to any employee at our company without a valid written search agreement in place for this position will be deemed the sole property of our company. No fee will be paid in the event a candidate is hired by our company as a result of an agency referral where no pre-existing agreement is in place. Where agency agreements are in place, introductions are position specific. Please, no phone calls or emails.