Commissioning Qualification Validation Engineer
Piper Companies
Piper Companies is currently looking for an experienced (CQV) Commission Qualification Validation Engineer in Raritan, NJ to work for an innovative and growing pharmaceutical organization. The primary responsibility of this role is to assist with the IQ/OQ/PQ of new instruments/equipment in support of manufacturing operations. Responsibilities Assist with the development of equipment validation protocols (IQ/OQ/PQ) for new instruments and ensure compliance with applicable regulations and guidelines. Conduct equipment validation testing and generate validation reports. Provide technical support to manufacturing personnel and troubleshoot any issues related to equipment performance or quality. Collaborate with cross‑functional teams to ensure timely completion of validation activities. Participate in risk assessments and provide recommendations for risk mitigation. Assist with the development and implementation of standard operating procedures related to equipment validation and qualification. Stay up‑to‑date with industry trends and regulations related to equipment validation and qualification. Qualifications Bachelor's degree in Engineering or a related field. Minimum of 5+ years of experience in equipment commissioning and validation in a pharmaceutical or medical device manufacturing environment. Strong knowledge of applicable regulations and guidelines related to equipment validation (e.g., FDA, EU, ICH). Experience with IQ/OQ/PQ protocols, process validation, and risk assessment. Excellent problem‑solving skills and attention to detail. Strong communication and interpersonal skills. Ability to work independently and as part of a cross‑functional team. Compensation Compensation Range is dependent upon experience. Comprehensive benefits package. #J-18808-Ljbffr Piper Companies
- ...Responsibilities CQV Execution & Safety - Perform Commissioning, Qualification, and Validation (CQV) activities with a strong focus on safety -... ...Qualifications and Experience - Bachelor’s degree (BS/BA) in Engineering, Chemistry, or Life Sciences (relevant experience can...SuggestedFor contractorsWorldwide
- ...teams in document development and/or execution Qualifications and Experience - Bachelor’s degree in a science or engineering field (or equivalent experience) - 2–4 years’ experience in commissioning and qualification in a regulated industry - Familiarity...SuggestedWorldwide
- ...Description We are seeking a Senior Validation Engineer with solid hands-on validation experience... ..., this position will focus on the qualification and validation of several Cellares... ...to the following: SOPs related to the commissioning, qualification and validation programs...SuggestedContract workFor contractorsFlexible hours
$84.5k - $162k
...Facebook, Instagram, X and YouTube. Job Description An engineering professional that works with project owners, subject... ...members to plan, and complete tasks associated with commissioning, qualification and validation of new and modified equipment, facilities, utilities,...SuggestedFull timeContract workTemporary workLocal areaMonday to FridayNight shiftWeekend work- CQV Engineer - Biotech Manufacturing, Isolators & VHP Validation & Engineering Group, Inc. (V&EG) a Pinnaql company is a leading services supplier who... ...Raritan, NJ. The selected candidate will support commissioning, qualification, and validation activities associated with...Suggested
- Veg Group is seeking a CQV Engineer for a biotechnology manufacturing expansion project in Raritan, NJ. The role will involve supporting commissioning, qualification, and validation for aseptic processing isolators and GMP manufacturing equipment. The ideal candidate should...
- ...and steadily grow. Job Description Responsibilities: Investigates and troubleshoots validation problems for equipment and/or performance processes and conducts equipment qualification activities. Conducts analyses of testing results and process anomalies. Focus on computerized...
$120k
...: Legend Biotech USA, Inc JOB TITLE: Validation Specialist JOB DUTIES: Execute site... ...reporting. Support equipment process qualification and ensure consistency with process needs... ..., rationales, and approval for engineering and process changes to meet regulatory...Permanent employmentFull timeTemporary workFor contractorsLocal areaWorldwideFlexible hours- ...experienced Advanced Manufacturing Engineer specializing in laser... ...(NPI), process validation, and continuous improvement... ...selection, specification, and commissioning including FAT/SAT Integrate... ...emerging laser technologies Qualifications: ~ Bachelor's degree in Mechanical...
$81.04k
...equipment; develop, execute, and review validation master plans, cleaning validation, and... ...with QA, QC, Manufacturing, Engineering, and R&D teams; analyze data from risk... ...compliance with FDA, ICH, and GMP standards. Qualifications BS degree in Biology, Biotechnology, Chemistry...Temporary workLocal areaWorldwideFlexible hours- ...Employment Type: Full-time Industry: Pharmaceuticals / Life Sciences Job Summary AAsys Technologies LLC is seeking a Quality/Validation Engineer with hands‑on expertise in GxP‑regulated environments and Computer System Validation (CSV). This role involves full lifecycle...Full time
- ...managed teams of at least 6-8 engineers and consultants on defined... ...8-12 years’ Experience commissioning and qualifying bio-pharma systems... ...with risk assessments, qualification protocols, commissioning... ...commissioning, qualification, validation, start-up, project...Full timeWorldwide
- ...The Powertrain Qualification Testing team operates in a fast-paced, dynamic environment within... ...in electrified and internal combustion engine (ICE) powertrains, ensuring the... ...solving. This role is responsible for the validation of production powertrain control modules...Full timeImmediate start
$93.46k - $122.67k
Job Overview QA Validation Specialist III role at BioSpace, based in Raritan, NJ. Exempt level position responsible for quality oversight of validation and qualification activities for equipment, systems, computer systems, and processes within a cell therapy manufacturing...Work at officeFlexible hours$70k - $82k
...Master Planning, Energy Audit, Building Commissioning, Measurement and Verification, and... ...services we provide. HES is hiring an Energy Engineer specializing in Building Commissioning... ...by project workload Personal Qualifications Strong analytical, writing, and...Full timeFor contractorsInternshipWork at officeShift work- ...innovative and highly motivated Senior Quality Validation Specialist, who will contribute... ...site automation, process validation & engineering documents, test protocols, CAPAs,... ...validation studies and process performance qualifications Provide oversight of cleanroom...Flexible hours
- Legend Biotech is a global biotechnology company dedicated to treating, and one day curing, life-threatening diseases. Headquartered in Somerset, New Jersey, we are developing advanced cell therapies across a diverse array of technology platforms, including autologous and...
- ...Katalyst CRO is looking for a CSV Consultant in Raritan, NJ to support system validation activities in a regulated environment. The consultant will ensure compliance with FDA guidelines, contribute to validation documentation, and work within the System Development Lifecycle...
- ...Gilder Search Group is seeking an Operations Readiness Project Engineer in Raritan, NJ. This onsite role supports multiple biologics and cell therapy projects through commissioning and operational startup. The ideal candidate will have 3–7 years of relevant experience...
$80k - $90k
Merck & Co. is looking for a Process Engineer to plan and execute validation assignments in Piscataway Township, New Jersey. This role involves preparing validation protocols, managing post-approval projects, and ensuring compliance with established quality standards. The...- ...Modem System Validation Engineer Bedminster, NJ (Hybrid) 12 Months Looking for someone with strong 5G protocol and troubleshooting skills. Responsibilities: Conduct research and analysis to define features and functions for 5G advanced and 6G. A firm...
$90k - $100k
...Automation Engineer The Automation Engineer is responsible for overseeing and... ...System etc. Perform programming, qualification and validation of digital process automation systems... ...operational start-up, calibration, and commissioning activities. Support Change...Full timeTemporary workLocal areaFlexible hours- ...Automation Engineer This is a contract position Location: Branchburg, New Jersey... .... Nice to have is Factory talk batch, Commissioning for manufacturing process –... ...either 12 am to 8 am, or 2 am to 10 am. Qualifications Skills: Pharma experience is...Contract workShift workAfternoon shift
- ...New Jersey Employment Type: Full Time Department: Engineering Reports To: Vice President of Operations About Us... ...workflows and contribute to continuous improvement initiatives. Qualifications ~ Bachelor’s degree in Mechanical Engineering,...Full time
$76k - $96.5k
...Job Description Job Description Manufacturing Engineer - Job Description This hands-on Manufacturing Engineer role supports... ...and evaluating candidates. AI helps assess applications and qualifications, but final decisions are made by our hiring team. By applying...Permanent employmentShift work$81.04k
...Raritan, NJ. The ideal candidate will conduct Quality Risk Assessments and collaborate with teams across QA, QC, Manufacturing, Engineering, and R&D. This position requires a BS degree and experience with risk assessment tools, including FMEA and HAZOP. The role offers...- ...lifecycle deliverables, including validation activities and associated... ...for OT Systems Users and Engineers in new automation... ...incident reporting. Qualifications Bachelor’s degree in Computer... ...texts. Experience with commissioning and qualification activities...Temporary workWork experience placementLocal areaNight shiftWeekend work
- ...Bonitasoft BPM) Quality assurance mindset for computer system validation for GMP, GDP, GLP space. Regulatory expertise to read and... ...performing special projects and related duties, as assigned. Qualifications: Experience in the BioTech/Pharmaceutical industry or similar...Local area
$100k - $120k
...Planning, Energy Audit, Building Commissioning, and Building Retro-... ...HES is hiring a Senior Energy Engineer with proven proficiency in Energy... ...not be considered. ~ A valid Professional Engineer (PE)... ...United States Personal Qualifications Strong analytical, writing...Full timeWork experience placementWork at officeShift work$70k - $82k
...Master Planning, Energy Audit, Building Commissioning, Measurement and Verification, and... ...services we provide. HES is hiring an Energy Engineer specializing in Energy Modeling to... ...by project workload Personal Qualifications Strong analytical, writing, and presentation...Full timeInternshipWork at officeLocal areaShift work
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