Associate Director, Equipment Development and Facility Engineering Technology Engineer

Job Description

The Enabling Facilities (EF) group within the Chemical Engineering Research & Development (CERD) Department is seeking a highly motivated individual to work in a fast-paced job that requires a high degree of process mechanical and engineering knowledge. The Equipment Development and Facility Engineering (EDFE) Technology Engineer position will report to the Associate Director Engineering and will be a member of the Modality Agnostic Chemistry Scaleup (MACS) EF Team at the Rahway NJ facility.

Enabling Facilities is responsible for the 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. EDFEs role within EF includes design installation qualification startup maintenance and troubleshooting of internal pilot plant equipment and the associated facility systems.

Responsibilities of the EDFE Technology Engineer include the following:

The Associate Director EDFE Technology Engineer role will serve as a team member supporting our companys API Pilot Facilities including the Small Scale Organics (SSO) Pilot Plant Preparatory (Kilo) Labs Unit Operations (UOps) Lab the Hazardous Reaction Lab (HRL) and the new Modality Agnostic Chemistry Scaleup (MACS) Center. MACS is a new potent multi-modality (small molecule macrocyclic peptides bioconjugates) drug substance process development and GMP clinical manufacturing plant currently being constructed in Rahway New Jersey. The Associate Director will serve as a valued team member during the MACS Center Execution and Startup Phases and will continue to support the facilitys operations after start-up.

While MACS is currently under construction the selected candidate will contribute to equipment design system commissioning/qualification and operational readiness planning to enable facility startup. Long-term the selected candidate will lead ongoing assessments and development of emerging or novel value-added technologies to support upcoming programs and to maintain relevance of the capabilities in each API facility previously listed.

Responsibilities include:

• Networking with partner groups including Project Teams Enabling Technologies Manufacturing Division groups Quality Safety and Commercial facilities to scout emerging technologies to enable the pipeline

• Partnering with chemists and engineers to develop the business case for new technology investments

• Assessment of pilot plant equipment and infrastructure capabilities to ensure sufficient capacity to support anticipated program needs

• Performing early assessments of proposed new technologies to identify feasibility

• Developing proposals for capital or expense projects to meet the defined needs

• Defining process mechanical electrical safety and instrumentation requirements

• Performing assessments of vendor offerings

• Providing technical oversight to internal/external construction efforts

• Prototyping and initial demonstration planning and execution

• Coordinating commissioning qualification and characterization for new equipmentand technologies to be used for GMP manufacture

• Socializing technology initiatives through internal and external presentations and publications and

• Engaging with partner organizations for successful scale-up to commercialization.

The candidate will regularly network with various chemists engineers and program leaders from partner organizations to identify external needs as well as facility engineers operations specialists compliance representatives and other EF team members.

A successful candidate will leverage these connections to stay well attuned to the status of current and planned research activities in a very dynamic environment demonstrating curiosity and passion for scouting assessing and facilitating installation of new process technologies which ultimately will contribute to the flexibility of the MACS facility and the speed and robustness of the Companys pipeline.

Education Minimum Requirement:

• Bachelor of Science degree in an Engineering or related scientific field with minimum of 10 years relevant experience or a Masters degree with 9 years of relevant experience or a PhD degree with 6 years of relevant experience

Required Experience and Skills

• A strong process and mechanical aptitude with the ability to read and understand P&IDs and technical/mechanical diagrams

• Desire to have regular hands-on presence on the plant/shop floor

• Process scale-up experience from laboratory to pilot plant and/or pilot plant to commercial

• Experience in pilot-plant scale process equipment instrument and automation design

• Familiarity with US and EU Safety and GMP compliance regulations

• Experience with GMP facility design equipment start-up and/or qualification

• Experience with Electrical Classifications for solvent and dust (Class I and II Div I and II) and understanding of its impact on equipment design

• Track record of establishing productive working relationships with process development scientists operators and external vendors

• Excellent organizational skills with an ability to multi-task

• Effective interpersonal and communication skills both verbal and written

• A collaborative mindset

• Desire and willingness to learn contribute and leadand

• Track-record of independent problem-solving.

Desired Experience and Skills:

• Experience operating/maintaining pilot scale or prep lab scale equipment

• Experience with Potent Compound processing and containment systems (e.g. isolators) or clean room facilities

• Familiarity with Change Management processes and principles

• Experience with preparing Standard Operating Procedures (SOP) and cGMP documents and

• History interacting with skilled trades (Piping Electrical Millwrights Instrumentation 3rd party contractors and vendors).

Required Skills:

Preferred Skills:

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Effective September 5 2023 employees in office-based positions in the U.S. will be working a Hybrid work consisting of three total days on-site per week Monday - Thursday although the specific days may vary by site or organization with Friday designated as a remote-working day unless business critical tasks require an on-site Hybrid work model does not apply to and daily in-person attendance is required for field-based positions; facility-based manufacturing-based or research-based positions where the work to be performed is located at a Company site; positions covered by a collective-bargaining agreement (unless the agreement provides for hybrid work); or any other position for which the Company has determined the job requirements cannot be reasonably met working remotely. Please note this Hybrid work model guidance also does not apply to roles that have been designated as remote.

The salary range for this role is

This is the lowest to highest salary we in good faith believe we would pay for this role at the time of this posting. An employees position within the salary range will be based on several factors including but not limited to relevant education qualifications certifications experience skills geographic location government requirements and business or organizational needs.

The successful candidate will be eligible for annual bonus and long-term incentive if applicable.

We offer a comprehensive package of benefits. Available benefits include medical dental vision healthcare and other insurance benefits (for employee and family) retirement benefits including 401(k) paid holidays vacation and compassionate and sick days. More information about benefits is available at can apply for this role through (or via the Workday Jobs Hub if you are a current employee). The application deadline for this position is stated on this posting.

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Los Angeles Residents Only:We will consider for employment all qualified applicants including those with criminal histories in a manner consistent with the requirements of applicable state and local laws including the City of Los Angeles Fair Chance Initiative for Hiring Ordinance

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