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.
• •Experience with smart technologies, such as robots, automated systems and/or computer integrated manufacturing equipment (mechatronics).
• •Experience operating, setting up, disassembling, and adjusting complex equipment, e.g. robotics, packaging machinery, automatic assembling machines.
• •Experience with quality systems.
• •Experience with new GMP facility startup.
• •Experience supporting Commissioning, Qualification and Validation.
• •Experience in supporting quality investigations and change management.

Working conditions:

• •This position may have varying hours based on the needs of the business
• •Flexibility working overtime is a requirement in manufacturing
• •Travel will be necessary for this role, including in-person training at a vendor.

FLEx2026

Sterile2026

#eligibleforERP

Required Skills:

Adaptability, Adaptability, Analytical Testing, Aseptic Handling, Aseptic Processing, Assembling Equipment, Assembly Automation, Chemistry, Clinical Supplies Management, Communication, Computer-Integrated Manufacturing (CIM), Data Analysis, Detail-Oriented, Deviation Management, Equipment Qualification, Equipment Set Up, Flexibility Training, Good Manufacturing Practices (GMP), Machine Assembly, Mechatronics, Networking Concepts, Packaging Machinery, Process Design, Process Equipment, Process Hazard Analysis (PHA) {+ 10 more}

Preferred Skills:

Current Employees apply HERE

Current Contingent Workers apply HERE

US and Puerto Rico Residents Only:

Our company is committed to inclusion, ensuring that candidates can engage in a hiring process that exhibits their true capabilities. Please click here if you need an accommodation during the application or hiring process.

As an Equal Employment Opportunity Employer, we provide equal opportunities to all employees and applicants for employment and prohibit discrimination on the basis of race, color, age, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, disability status, or other applicable legally protected characteristics. As a federal contractor, we comply with all affirmative action requirements for protected veterans and individuals with disabilities. For more information about personal rights under the U.S. Equal Opportunity Employment laws, visit:

EEOC Know Your Rights

EEOC GINA Supplement​

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.

Learn more about your rights, including under California, Colorado and other US State Acts

The primary location for this posting is:

• USA - New Jersey - Rahway
• Where required by law, the compensation range for this role is provided below.

The salary range