Process Engineer

Katalyst Healthcares and Life SciencesWarren, NJ, United States

3 days ago

Job type

Permanent

Job description

Job Description :

Experience in cell therapy / biologic / vaccine manufacturing support, tech transfer, and validation.
The Manufacturing Sciences and Technology Engineer Clinical CAR-T Engineering and Technology Support is responsible for supporting the production of personalized cell therapy products for global clinical trials. Collaborates with SMEs from the Development Group, Global MSAT Group, Supply Chain Group, Manufacturing Group, and Quality Group while providing technical support for the resolution of process deviations, the evaluation and implementation of process changes and continuous improvement support to the production operations to ensure rapid, flawless, compliant, and cost-effective delivery of quality products.

Responsibilities :

Ensure safe and compliant cGMP operations.

Maintain permanent inspection readiness and actively support regulatory inspections.

Interface with regulatory authorities as required to support Manufacturing Operations audits.

Foster a culture of compliance and strong environmental, health, and safety performance.

Stay current with industry trends and standards (e.g. PDA, ISPE) and participate in best practice forums consistent with function responsibilities.

Provide technical input and investigation support for production related investigations, ensuring compliance with internal standards and regulatory requirements

Design and execute test plans and other risk mitigation exercise as part of investigations (e.g. Root cause analysis and CAPAs).

Sponsor and support the change initiatives and the implementation of process improvement initiatives.

Support Clinical Production Activities.

Support production related investigations, ensuring compliance with internal standards and regulatory requirements.

Continuously monitor, anticipate and permanently resolve issues that may arise during production.

Interface with operators and serve as process SME. Learn the procedures, analytics and document any known sensitivity.

Provide technical input and investigation support for production related investigations, ensuring compliance with internal standards and regulatory requirements.

Work closely with Engineering / Maintenance on the design and implementation of new technology and new systems / facilities related to production process needs.

Review and revise the content of technical documentation (e.g. investigations, changes, SOPs and batch records).

Interact with other teams including Validation, Development, Operations, QA and Regulatory.

Display Leadership Qualities.

Create an environment of teamwork, open communication, and a sense of urgency.

Support the change agent in promoting flexibility, creativity, and accountability.

Support organizational strategic goals and objectives that are linked to the overall company strategy.

Drive strong collaboration within the plant and across the network.

Build trust and effective relationships with peers and stakeholders.

Deliver results through timely and quality decision making and advice.

Promote a mindset of continuous improvement, problem solving, and prevention.

Lead project teams, prepare project schedules, coordinate the execution of technical projects and develop presentations to disseminate results to project stakeholders and senior management.

Requirements :

Bachelor's degree required.

Design and execute test plans and other risk mitigation exercise as part of investigations (e.g. Root cause analysis and CAPAs).

Experience in GMP setting and CAR-T cell therapy.

Sponsor and support the change initiatives and the implementation of process improvement initiatives.

Support Clinical Production Activities.

Basic knowledge of cGMP's and multi-national biopharmaceutical / cell therapy regulations.

Basic knowledge of facility / clean room design, process, equipment, automation, and validation.

Intermediate strong verbal / written communication skills and ability to influence at all levels.

Intermediate ability to think strategically and to translate strategy into actions.

Intermediate ability to prioritize and provide clear direction to team members in a highly dynamic environment.

Basic knowledge of quality by design and risk management.

Basic experience with Operational Excellence and Lean Manufacturing.

Experience with the start-up, validation, and licensure of new biopharmaceutical manufacturing facilities.

Bachelor's Degree required in Engineering or Related Discipline (advanced degree is preferred).

2 or more years of manufacturing support or related experience in the biopharmaceutical industry.

Working Conditions : (US Only) .

A. Physical / Mental Demands :

Work is performed in a typical office environment, with standard office equipment available and used. Work is generally performed seated but may require standing and walking for up to 10% of the time.

B. Environmental Conditions :

Lighting and temperature are adequate and there are no abnormal conditions caused by noise, dust, etc.

This job description is intended to describe the general nature and level of work being performed by the person assigned to this position. The primary duties and responsibilities are intended to describe those functions that are essential to the performance of this job.

This job description does not state or imply that the above are the only duties and responsibilities assigned to this position. There are other duties and responsibilities that are considered incidental or secondary to the overall purpose of this job. Employees holding this position will be required to perform any other job-related duties as requested by management.

Create a job alert for this search

Engineer • Warren, NJ, United States

Related jobs

Promoted

Process Engineer

Trumpf, Inc.Cranbury, NJ, United States

Full-time

As a family-run, high-tech company with nearly 19,000 employees at 71 locations worldwide, we are looking for forward thinkers with unconventional ideas and drive to join our team.Our company cultu...Show moreLast updated: 30+ days ago

Promoted

Manufacturing Engineer - Entry Level, Continuous Improvement

HowmetDover, NJ, United States

Full-time

Box 371, Dover, NJ, 07801-0371, US.Remote Work Schedule Availability?.This position entails access to export-controlled items and employment offers are conditioned upon an applicant's ability to la...Show moreLast updated: 7 days ago

Promoted
New!

Process Engineers

Scientific SearchParsippany, NJ, US

Full-time

Do you thrive on optimizing systems, improving yields, and driving operational excellence? Whether your background is in. Process Engineers to enhance production efficiency, scale technologies, and ...Show moreLast updated: 15 hours ago

Promoted

Process Engineer

Lapp GroupFlorham Park, NJ, United States

Full-time

LAPP is a family-owned company headquartered in Stuttgart and a global leader in cable and connection technology.Founded in 1959, we are still fully family-owned today. With around 5,800 employees, ...Show moreLast updated: 3 days ago

Promoted

Process Engineer

RoquetteNewark, NJ, United States

Full-time

Want to help us make a difference?.Using plant-based resources, we collaborate with our customers and partners to imagine and offer ingredients to better feed people and treat patients.Each of our ...Show moreLast updated: 30+ days ago

Promoted

Process Engineer

Astrix TechnologySomerville, NJ, United States

Full-time

Our client who is a global, Fortune 100 Medical Device company is seeking a Process Engineer to join their team in Somerset Count, NJ. We are seeking a Process Engineer with 1+ years of experience i...Show moreLast updated: 3 days ago

Promoted

Business Process Engineer

DreamLine ShowerWarminster, PA, US

Full-time

Location : 4 days on-site in Warminster, PA; 1 day (Thursday) work-from-home.Reports to : Director of AI Solutions & Business Partner. About American Bath Group (ABG) : .American Bath Group (ABG) is...Show moreLast updated: 22 days ago

Principal Process Engineer

Eli LillyBranchville, NJ, US

Full-time

At Lilly, we unite caring with discovery to make life better for people around the world.We are a global healthcare leader headquartered in Indianapolis, Indiana. Our employees around the world work...Show moreLast updated: 30+ days ago

Promoted

Mechanical Engineer PE (Data Centers)

JobotEdison, NJ, US

Full-time

Sr Mechanical Engineer PE (Data Center Design / Build) - Hybrid.This Jobot Job is hosted by : Tony Barhoum.Are you a fit? Easy Apply now by clicking the "Apply Now" buttonand sending us your...Show moreLast updated: 30+ days ago

Promoted

Process Sustaining Engineer, 2nd Shift

1014 AD FederalAlpha, MA, United States

Full-time +1

NASDAQ : ADI ) is a global semiconductor leader that bridges the physical and digital worlds to enable breakthroughs at the Intelligent Edge. ADI combines analog, digital, and software technologie...Show moreLast updated: 30+ days ago

Promoted

Process Engineer

WestRockDelaware Water Gap, PA, United States

Full-time

Job Code : MEPEP1 + Eng I, Process Eng.Location : Delaware Water Gap, PA.The Process Engineer is responsible for managing technical projects aimed at product and process problem-solving and / or improv...Show moreLast updated: 30+ days ago

Promoted

Engineer Process Owner- Monoshell

HowmetDover, NJ, United States

Full-time +1

Roy Street, Dover, NJ, 07801-4308, US.Remote Work Schedule Availability?.This position entails access to export-controlled items and employment offers are conditioned upon an applicant's ability to...Show moreLast updated: 3 days ago

Process Engineer

Prysmian GroupBridgewater, New Jersey, United States

Full-time

Quick Apply

The Process Engineer will design processes and equipment for manufacturing, monitor equipment through regular testing, and provide strategic oversight of the processes being deployed (including rol...Show moreLast updated: 30+ days ago

Promoted

Process Modeling Development Engineer - New Production Introduction

HowmetDover, NJ, United States

Full-time

Promoted

Process Expert

Novartis Group CompaniesMorris Plains, NJ, United States

Full-time

The Process Expert will provide front line support for all issues related to the manufacturing process, continuously improving in quality and efficiency, and in compliance to cGMPs, SOPs and applic...Show moreLast updated: 30+ days ago

Promoted

Process Engineer

Astrix IncSomerset, NJ, United States

Full-time

Promoted

Senior Process Engineer I Biscuit R&D (North America)

New Jersey StaffingEast Hanover, NJ, United States

Full-time

Are you ready to make it happen at Mondel?z International? Join our mission to lead the future of snacking.As a Senior Process Engineer I, you will play a key role in enabling ingredient transition...Show moreLast updated: 3 days ago

Promoted

Process Engineer

Sokol Materials & ServicesSkillman, NJ, United States

Full-time

On-site position (no remote or hybrid options).Applicants must have the legal right to work in the United States without requiring sponsorship. Corp-to-Corp (C2C) arrangements are not accepted.Bache...Show moreLast updated: 3 days ago