Top 11 Senior process engineer Jobs in Middlesex, Nj

Senior Process Engineer
Cellares —Bridgewater, NJ
- $90,000 - $210,000 a year
- Full-time
- 5 years
- Bachelor's degree
- Senior level
Senior Process Engineer, MS&T
Rocket Pharmaceuticals —Cranbury, NJ
- $118,000 - $158,000 a year
- Full-time
- Bachelor of Science
- Bachelor's degree
- Doctor of Philosophy
- Paid holidays
- Health insurance
10d
Senior Engineer, Facility Operations (On-site)
Merck —Rahway, NJ
- $117,000 - $184,200 a year
- Full-time
- 3 years
- Master's degree
- Bachelor's degree
- Paid holidays
- Health insurance
7d
Senior Auditor, Auditing and Due Diligence
Alvogen, Inc —Morristown, NJ
- $135,000 - $142,000 a year
- Full-time
- Up to 50% travel
- 5 years
- Computer literacy
- Wellness program
- Health savings account
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Sr Quality Engineer, Design Assurance
Integra LifeSciences —Princeton, NJ
- $81,650 - $112,700 a year
- Email
- Schematics
- Engineering
- Analysis skills
- Disability insurance
- Health insurance
Senior Chemist, R&D
Arxada —Morristown, NJ
- Full-time
- 5 years
- Doctor of Philosophy
- Senior level
Business Process Engineer Sr. Process Design Specialist II
Horizon Blue Cross Blue Shield of New Jersey —Newark, NJ
- $109,600 - $149,625 a year
- Full-time
- Writing skills
- High school diploma or GED
- Bachelor's degree
- Health insurance
- Dental insurance
Lead Hydrometallurgy Engineer
Still Bright —Kenilworth, NJ
- From $156,000 a year
- Full-time
- Spanish
- Master's degree
- 8 years
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Senior Process Engineer

Cellares
Bridgewater, NJ

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Job Details

Full-time
$90,000 - $210,000 a year

Qualifications

Content creation for technical audiences
Safety protocol adherence
Technical documentation
Pharmaceutical regulatory compliance
Technical writing experience within manufacturing
Manufacturing facility experience
Bachelor's degree
Pharmaceutical company experience
Technology transfer (scale-up process)
Compliance documentation
Bioprocessing
Factory experience
Production documentation
Pharmaceutical manufacturing facility experience

Full Job Description

Position Summary

We are seeking an innovative and highly motivated Senior Process Engineer on our MSAT team who will contribute significantly to the development of our advanced cell therapy manufacturing platform.

This position is responsible for supporting the activities involved in development, process transfers, compliance, and scalability for Cellares’ manufacturing operations. This individual will focus on technology transfers from Process Development into GMP manufacturing facilities, as well as driving and developing process automation and scalability solutions to improve process reliability, safety, cost-effectiveness, scalability, and compliance.

This is a multidisciplinary role & this individual will interface across many parts of the company (with customers, scientists, researchers, and engineers) to develop the best solutions possible. The successful candidate will be a resident expert in the areas of technology transfer and manufacturing science and technology. It is expected that this individual will work closely with other corporate functional areas and partners to ensure deliverables are met. Candidates should enjoy working in a fast-paced, mission-driven environment, and be prepared to tackle a broad selection of challenges as the company grows.

Responsibilities

Work to identify and communicate standards and best practices for process design and manufacturing to ensure consistency across manufacturing of cell therapies
Work as the MSAT representative on client projects
Lead activities to transfer processes to manufacturing from internal Cellares process development at other sites or directly from customers
Lead Master Validation Plan creation in order to support PPQ campaigns
Lead and drive technology adoption program initiatives, including ROI analyses with internal and external stakeholders
Support development of manufacturing operations including GMP system implementation and tasks related to GMP readiness
Support process development and process comparability activities on Cellares technology as required
Support development and review of relevant SOPs for manufacturing operations and systems. Author and review global program policies Perform manufacturability assessments for new process introductions
Define and provide user requirements for process equipment associated with multiple facilities for the manufacture of cell therapies
Work with our software team on integration solutions for the manufacturing process and data management, including eBR, MES, QMS, and LIMS
Work with our software team to provide feedback on internal software solutions
Provide technical support to Manufacturing and other departments associated with GMP operations
Support or author product quality impact assessment for major deviations. Provide input when troubleshooting processes on the manufacturing floor and during post-operational investigations
Maintain and report process run summaries, and continued process verification reports
Prepare and present data associated with manufacturing processes to internal and external partners
Support for process qualification and validation preparation, execution, and reporting
Work with clients on process mapping of the manufacturing processes
Other duties as assigned

Requirements

Bachelor’s Degree in a scientific or related field is required
A minimum of 5+ years of experience within the biotech/biopharma industry in cGMP Operations, preferably within cell and gene therapy
Experience in the Pharma/Biotech industry in technology transfer
Must know and follow job safety procedures, attend required health and safety training, proactively promote safety at work, and promptly report actual and potential accidents and injuries. Must comply with safety policies of the company and site
Adherence to cGMPs is required all times during the manufacture of Cell Therapy products. All personnel are responsible for notifying responsible management in a timely manner of regulatory inspections, serious GMP deficiencies, product defects and related actions
Relevant experience bringing biotechnology equipment and processes from design through GMP operational readiness is a plus
Must have experience writing, reviewing and approving GMP documentation
Self-motivated and passionate about advancing the field of cell therapy
Self-awareness, integrity, authenticity, and a growth mindset
Desire to be part of a rapidly evolving organization, with a compelling technology, and taking products and processes to the next level
Excellent planning, organization, technical writing, and time-management skills including the ability to support, problem-solve, and prioritize multiple projects and deadlines.

$90,000 - $210,000 a year

This is Cellares

Cellares is the first Integrated Development and Manufacturing Organization (IDMO) and takes an Industry 4.0 approach to mass manufacturing the living drugs of the 21st century. The company is both developing and operating integrated technologies for cell therapy manufacturing to accelerate access to life-saving cell therapies. The company’s Cell Shuttle integrates all the technologies required for the entire manufacturing process in a flexible and high-throughput platform that delivers true walk-away, end-to-end automation. Cell Shuttles will be deployed in Cellares’ Smart Factories around the world to meet total patient demand for cell therapies at global scale. Partnering with Cellares enables academics, biotechs, and pharma companies to accelerate drug development and scale out manufacturing, lower process failure rates, lower manufacturing costs, and meet global patient demand.

The company is headquartered in South San Francisco, California with its commercial-scale IDMO Smart Factory in Bridgewater, New Jersey. The company is backed by world-class investors and has raised over $355 million in financing.

Leveling will be based on overall experience, education, and demonstration of knowledge throughout the interview process.

We may use artificial intelligence (AI) tools to support parts of the hiring process, such as reviewing applications, analyzing resumes, or assessing responses and identifying potential inconsistencies or verification signals in application materials based on available information. These tools assist our recruitment team but do not replace human judgment. Final hiring decisions are ultimately made by humans. If you would like more information about how your data is processed, please contact us.

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Refine Your Search

senior process engineer jobs in middlesex, nj

Senior Process Engineer

Senior Process Engineer, MS&T

Senior Engineer, Facility Operations (On-site)

Senior Auditor, Auditing and Due Diligence

Sr Quality Engineer, Design Assurance

Senior Chemist, R&D

Business Process Engineer Sr. Process Design Specialist II

Lead Hydrometallurgy Engineer

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