Facility Engineer, MACS Senior Specialist (On-site)

Merck

Rahway, NJ

Estimated pay: Est. $35–$49/hr (market estimate, not employer-stated)

Shift: Full time

Job Description Description: The Enabling Facilities group within the Chemical Engineering Research Development Department is seeking a highly motivated individual to work in a fast-paced job that provides a high degree of technical, mechanical, and project management responsibility. The Facility Engineer position will report to the Associate Director, Engineering and will be a member of the Equipment Development and Facility Engineering team. Enabling Facilities is responsible for development of new technologies/capabilities, execution of capital and non-capital improvement projects, and the automation system assets spanning production, utility systems and associated infrastructure. Equipment Development and Facility Engineering role within Enabling Facilities includes design, installation, qualification, startup, maintenance, troubleshooting and continuous improvement of equipment. Responsibilities: This role at the Sr. Specialist level will serve as a technical mentor and process team member supporting the Modality Agnostic Chemistry Scaleup Center . This is a new potent, multi-modality (small molecule, macrocyclic peptides, bioconjugates) Drug Substance development and Good Manufacturing Practice clinical manufacturing plant currently under construction. As the Modality Agnostic Chemistry Scaleup Center is nearing construction completion, the selected candidate will contribute to completing the capital project by supporting construction close-out, equipment and facility commissioning/qualification, as well as other critical operations readiness activity workstreams. The selected candidate is expected to foster a culture of collaboration, learning and innovation within Enabling Facilities, the Modality Agnostic Chemistry Scaleup Capital Project and Modality Agnostic Chemistry Scaleup Operations. After the facility starts up, they will collaborate closely with Enabling Facilities and Modality Agnostic Chemistry Scaleup Operations team members, development engineers chemists, and compliance representatives, to ensure the quality and safe delivery of clinical supplies, the availability and reliability of facilities, the scientific rigor of the processes and ultimately enable flexibility and speed in the Company’s pipeline. Additional Supported Areas: The Sr. Specialist may also support new and/or existing facilities across the Small Molecule Process Research Development network and Enabling Facilities capital projects as required. Examples of these other areas are: Small Scale Organics Pilot Plant (SSO): The SSO is a Good Manufacturing Practice manufacturing facility in the Process Research and Development organization. The pilot plant’s mission is to serve as Process Research and Development internal node for small molecule drug substance clinical manufacture, and as preferred site for first pilot of commercial small molecule processes, enabling gain of critical internal experience with scale-up of manufacturing Good Manufacturing Practice steps, demonstration of new manufacturing technology/processes, training opportunities for improved manufacturing process development and seamless tech transfer to commercial sites. Prep Lab Area : The Prep Lab is used to generate data which contributes to process definition and provides Phase I/IIa clinical material when needed. This kilo scale capability establishes reaction parameters and ensures successful batches when transferring to pilot scale. Areas of the Prep Lab have been and are continuing to be upgraded to support pipeline programs such as ADCs, PDCs, and other cross modality compounds that require a more flexible potent compound processing space. Minimum Requirements: Required Education: Bachelor of Science degree in an Engineering or related scientific field with minimum of 6 years relevant experience, or Master’s degree with 5 years of relevant experience, or PhD degree with 2 years of relevant experience Required Experience and Skills: Experience with Good Manufacturing Practice facility design and equipment start-up and/or qualification. Strong mechanical aptitude. Ability to read and understand P IDs. Familiarity with Electrical Classifications for solvent and dust (Class I and II, Div I and II). Experience in Process Hazard Analysis (PHA) and/or Level of Protection Analysis (LOPA) Experience interacting with skilled mechanical tradesmen and construction management organizations. Experience operating/maintaining manufacturing, pilot scale or prep lab scale equipment. Experience in supporting compliance investigations and change management. Familiarity with US and EU Good Manufacturing Practice and Safety compliance regulations Familiarity with Change Management processes and principles. Ability to comprehend and/or prepare Standard Operating Procedures and Good Manufacturing Practice documents. Fluent in Microsoft Office, use of email, and meeting facilitation. Effective interpersonal and communication skills, both verbal and written. Sound decision-ma