Sr. Specialist, Engineering (Onsite)

Job Description

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, which is currently in the operational startup phase. 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).

We are seeking a Senior Specialist, Technical Operations – Engineering, to serve as a key technical specialist in the FLEx Sterile Expansion Project, focused on the Optima multi-use filling line. This expansion project aims to more than double the capacity of the existing FLEx Sterile Facility by adding a second clinical filling/lyophilization suite, a formulation suite, and a sterile supply suite, along with various supporting infrastructure and utilities.

The selected candidate will upskill on the Optima Multi-use filler through a multi-week in-person training at the Optima Pharma and Isolator facilities, located in Germany. The candidate will become proficient in mechanical, automation, and system wide troubleshooting. At the conclusion of the training program, the candidate will be a key resource for the commissioning and qualification of the multi-use filler line at the FLEx Center.

This role presents an exciting opportunity to collaborate with our research formulation scientists, capital design engineers, safety and quality representatives, digital and IT teams, equipment vendors, and other stakeholders. Together, you will drive the ensure the successful execution of the project C&Q and startup phases.

When operations commence, this individual will partner closely with the formulators, engineers, Quality representatives, and other team members to ensure the quality of the clinical supplies, the scientific rigor of the processes, and ultimately to enable flexibility and speed of our Company's sterile pipeline.

Key Responsibilities

• Collaborate closely with a range of stakeholders to gain insights into equipment and facility design, maintenance, troubleshooting, operational excellence, financial and capital management, team building, process sciences, technical writing, and networking.
• Work with a variety of state-of-the-art aseptic drug product filling, and lyophilization equipment while completing processes throughout the manufacturing cycle.
• Attend and complete the Optima Super user training at the Optima sites in Germany (10-12 weeks).
• Provide training on advanced troubleshooting and support functions to operators and engineers.
• Support individual project assignments and aid in facility and process equipment innovation.
• Perform manual and/or automated operations, general maintenance, troubleshooting and support functions.
• Perform aseptic manipulations within Grade A barrier isolation systems.
• Contemporaneous record keeping including equipment and area cleaning and use logs, and all pertinent batch and/or equipment preparation documentation.
• Identify and addresses compliance, environmental, safety, and process deviations as appropriate while notifying appropriate personnel.
• Demonstrate, at all times, safe work habits and maintain a safe work environment. Comprehend and comply with all safety and company policies and procedures.
• Attend training classes, workshops, meetings, etc., as needed to improve job skills and product-related procedures.

Education Minimum:

• B.A./B.S. in Mechatronics, Engineering, Automated Sciences, Computer Science, Biology, Chemistry or equivalent with at least 5 years of relevant experience.
• Master’s degree with a minimum of 3 years relevant experience.

Required Experience and Skills:

• Ability to do all required gowning and personal protective equipment ex. Powered Air Purifying Respirator.
• Strong attention to detail and documentation skills are required.
• Ability to communicate and work in partnership with other employees in a manufacturing environment.
• Ability to prepare Standard Operating Procedures and current GXP documents.
• Demonstrated skills in problem-solving and troubleshooting.
• Effective communication skills, both verbal and written.
• Familiarity with United States and European Union cGMP and Safety compliance regulations.
• Effective interpersonal and communication skills, both verbal and written.
• Experience in drug product aseptic processing, equipment and aseptic technique.
• Training Requirement: Selected candidates will complete a mandatory 10–12 week training program in Germany to gain the technical knowledge and hands-on experience required for success in the role. Candidates must be willing and able to travel internationally for the duration of the training.

Preferred:

• Experience with automated aseptic filling lines.

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