Process Engineer
Katalyst HealthCares & Life Sciences
Job-ID Reference Job Summary: We are seeking a highly skilled Sr. Engineer – Process Development (CQV) to support automated and semi-automated combination product assembly, labeling, and packaging operations within a GMP Final Drug Product (FDP) manufacturing environment. The role involves leading commissioning, qualification, and validation activities for both new and existing equipment and processes, ensuring compliance with FDA regulations and internal quality standards. The Sr. Engineer will serve as the site's technical expert for automated systems and combination product validation, collaborating closely with Engineering, Quality, and Manufacturing teams. Roles & Responsibilities: Lead commissioning, qualification, and validation activities for automated and semi-automated combination product equipment and processes. Author, review, and execute validation protocols, including Installation Qualification (IQ), Operational Qualification (OQ), and Performance Qualification (PQ). Maintain and manage Master Validation Plans and related documentation to ensure compliance with GMP and FDA regulations. Serve as the technical SME for automated systems, labeling, and packaging process validation. Collaborate with cross-functional teams (Engineering, Quality, Manufacturing) to ensure robust and validated systems supporting 24/7 production operations. Conduct on-site and off-shift validation activities as needed to support continuous manufacturing operations. Identify process gaps and recommend improvements to optimize validation and operational efficiency. Support regulatory audits and inspections by providing accurate and complete validation documentation. Education & Experience: Bachelor's or Master's degree in Engineering, Life Sciences, or related technical field. Proven experience in Commissioning, Qualification, and Validation (CQV) within a GMP-regulated manufacturing environment. Hands-on experience with automated and semi-automated equipment, labeling, and packaging operations. Strong knowledge of FDA regulations, GMP standards, and internal quality systems. Experience with validation documentation including Master Validation Plans, IQ/OQ/PQ protocols, and reports. Familiarity with Kneat software is a plus. Ability to work flexible schedules, including on-site and off-shift validation activities.
- ...Job Description Job Description Job Overview The Process Engineer will be responsible for improvements relating to industrial/manufacturing processes and efficiency to reduce costs, improve sustainability, and maximize profitability. This role will be directly...SuggestedWork at office
Raycap Inc
Kearny, NJ19 days ago - Reports To: Manufacturing Engineering Manager Position Summary The Process Engineer is responsible for developing, implementing, optimizing, and sustaining manufacturing processes that improve product quality, operational efficiency, safety, and cost performance across...SuggestedWork at office
- Job-ID32818011Reference26-01397 Job Description: We are seeking an experienced Process Validation Engineer to support new pharmaceutical manufacturing projects within a sterile GMP environment. This role will focus on process validation, technology transfer, and qualification...Suggested
$80k - $180k
GFT is seeking a Water Treatment Process Engineer to join our Water team! This role follows a hybrid work model, requiring regular attendance at one of our many offices.Joining the water engineering team at GFT means contributing to innovative solutions for sustainable...SuggestedFull timeRemote work- ...Why Join Us? Are you an engineer who loves seeing the direct impact of your work from the drawing board to the field? At [Company... ...solve critical environmental challenges. As an Application & Process Engineer , you won't be stuck behind a desk or hidden in a lab...Suggested
Ground Water Treatment
East Hanover, NJ1 day ago $105.5k - $243k
HPEFS Sr. Process EngineerThis role has been designed as ‘’Onsite’ with an expectation that you will primarily work from an HPE office... ...opportunities with HPE.Job Description:We are seeking an HPEFS Sr. Process Engineer to support our Spring, TX or Berkeley Heights, NJ on a hybrid...Full timeWork experience placementWork at officeLocal areaImmediate start- ...Kinsley Power Systems is seeking an Industrial Sales Engineer to add to their team! The Industrial Sales Engineer's main objective is to sell industrial power generation applications including related equipment (transfer switches, switchgear, load banks, fuel tanks, etc...Contract workFor contractorsWork at officeFlexible hoursNight shift
Kinsley Group
Newark, NJ21 days ago - ...Role: Process Engineer Type: Fulltime Location: Clifton New jersey Prioritized Must Have Skills for the Process Engineer: #1. Bachelor's degree in Mechanical Engineering, Metallurgical Engineering, or related engineering field...Full time
VBeyond
Clifton, NJ5 days ago $87.3k - $137.4k
...Product development and Good Manufacturing Practice (GMP) clinical supply manufacturing facility in Rahway, New Jersey.The Sterile Process Engineer role at the Specialist level will leverage the individual’s leadership, technical, and communication skillsets to drive the...Full timeFor contractorsLocal areaFlexible hours$100k - $130k
...Incident, Problem & Change Management DR and Business Continuity processes Create L1-L4 process maps, SIPOC diagrams, and RACI matrices.... ...opportunities for automation and self-service. Work with engineering teams to implement: Infrastructure as Code (Terraform, Ansible...- Arcadis is seeking a talented and driven Process Engineer with strong PLC (Programmable Logic Controller) experience to join our manufacturing operations team. You will be responsible for optimizing, troubleshooting, and improving manufacturing processes, ensuring compliance...Full timeTemporary workPart timeRelocation
- Description Overview: ValSource is currently looking to find bright, enthusiastic and experienced leaders in Process Engineering to support exciting GMP Drug Substance and Drug Product capital projects throughout our network. These individuals will be empowered to lead...Full timeTemporary workFor contractors
$108k - $148.5k
...Applied Materials is the global leader in materials science and engineering solutions that are at the foundation of virtually every new... ...or wherever you may go. Learn more about our benefits. As a Process Engineer, you'll play a crucial role in designing and optimizing...Full timeRelocation- Position Summary Responsible for special projects and related engineering assistance in support of manufacturing operations. Primary Responsibilities... ...with Divisional Engineering on new jobs related to PPAP and process items. Communicate foreseen issues with Technical Manager for...Work at officeLocal areaShift work
- ...the highest levels of manufacturing consistency, quality control, and safety. Description As a member of the global Aurorium Process Engineering Team, the Senior Process Engineer is responsible for executing business unit driven process development programs using...Work at officeFlexible hours
$198k - $264k
...online safely and at scale. The Principal Operational Readiness Engineer will serve as a senior technical leader responsible for... ...operational and technical reviews of projects to identify gaps in process execution, design validation, construction coordination, turnover...Permanent employmentFull timeFor contractorsCasual workWork at officeCoreWeave
Livingston, NJ2 days ago$87.3k - $137.4k
...development and Good Manufacturing Practice (GMP) clinical supply manufacturing facility in Rahway, New Jersey. The Sterile Process Engineer role at the Specialist level will leverage the individual's leadership, technical, and communication skillsets to drive the...Full timeFor contractorsLocal areaRelocationVisa sponsorshipFlexible hoursShift workMerck & Co.
Rahway, NJ3 days ago- ...PTR Global is seeking a Mainframe Engineer with expertise in CA7 and a strong background in automation. The role requires extensive hands-on experience with CA7, including configuration, troubleshooting, and system integrations. Proficiency in Python and REXX is essential...Contract work
PTR Global
Jersey City, NJ4 days ago - ...Business Process Improvement Manager A Few Words About Us Integrated Resources, Inc is a premier staffing firm recognized as one... .... Education/Experience: Requires a Bachelor's degree in an engineering, business, or technical discipline from an accredited college...Full time
Integrated Resources
Newark, NJ5 days ago $127.2k - $190.8k
...where you can make an impact.With interesting opportunities in engineering, marketing, sales, supply chain, operations, HR, finance, and... ...technologies shaping modern life. Position SummaryAdvanced Processing Engineer is to lead advanced machining, automation, and process...Full timeLocal area- ...Job Title: Nuclear Engineer (Naval Reactors Engineer) Category / Component: Officer • Active Overview Design, regulate, and oversee the Navy's nuclear propulsion program, including reactor design, fleet operations, and eventual defueling and decommissioning of...ApprenticeshipWork at office
US Navy
East Orange, NJ4 days ago $59.15k - $106.93k
...your career is good business. Leidos is seeking Distribution Engineers & Designers in New Jersey who are passionate about electric... ...through design approved, including Customer interaction and Process documentation ~ Experience with utility reliability projects...Work at officeLocal areaImmediate startRemote workFlexible hoursLeidos
Newark, NJ2 days ago$78k - $100k
...committed to bringing passion and customer focus to the business. Engineering 1 is a foundational role at Creation Technologies, focused on... ...in the creation, configuration and optimization of industrial processes required to produce and/or test Circuit Card Assemblies (CCAs)...Permanent employmentFull timeLocal areaShift workCreation Technologies International Inc
Newark, NJ21 days ago$109k - $120k
...national origin, medical condition, disability, veterans status, or any other basis protected by law.About the job:As a Production Engineer, you’ll join WebMD’s SRE team to manage, improve, and evolve our entire backend stack. In this role, you will focus heavily on...Full timePart timeFlexible hours$82k - $97k
...protected by law. About the role: As a Vendor Risk & Compliance Engineer, you will be uniquely positioned to enhance Vendor risk program... ...: ~AI Proficiency aiming to improve accuracy and accelerate process improvement ~4 –6 years leading vendor and third-party risk...Full timePart timeFlexible hoursWebMD
Newark, NJmore than 2 months ago$95k - $160k
...is leveraging recent breakthroughs in stellarator physics and engineering to create a faster and simpler approach to commercializing fusion... ...intelligence (AI) tools to support parts of the hiring process, such as reviewing applications, analyzing resumes, or assessing...Night shiftWeekend workThea Energy
Kearny, NJmore than 2 months ago$25 per hour
...is leveraging recent breakthroughs in stellarator physics and engineering to create a faster and simpler approach to commercializing fusion... ..., and test. Direct experience with fabrication or assembly processes such as machining (hand tools, manual mill, CNC), fastened and...InternshipThea Energy, Inc.
Kearny, NJ3 days ago- ...OQ, and PQ. Experience with equipment, facility, utility, or process validation. Strong knowledge of GMP, GxP, and FDA regulations.... ...activities. Strong technical writing and documentation skills. Ability to work with Engineering, Quality, Manufacturing, and Validation teams.
$160k - $230k
...is leveraging recent breakthroughs in stellarator physics and engineering to create a faster and simpler approach to commercializing fusion... ...intelligence (AI) tools to support parts of the hiring process, such as reviewing applications, analyzing resumes, or assessing...Work experience placementThea Energy
Kearny, NJa month ago- ...Context of Job Under limited direction, the Energy Systems Engineer will maintain and enhance the physical and enterprise infrastructure... ...and facilities, evaluating energy systems, equipment, and processes to identify areas of energy waste, such as inefficient lighting...
University of Delaware
Newark, NJmore than 2 months ago
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