GMP Instrument Validation Specialist | 21 CFR 11 & SDLC
Merck
Merck & Co., Inc. in Rahway, NJ seeks an Analytical Instrument Validation Specialist to drive GMP-compliant validation of novel analytical equipment across DSCS networks. You will partner with scientific teams to ensure quality and operational excellence, support SDLC documentation, and contribute to readiness for internal and external audits. The role requires a Bachelor's in analytical chemistry or related field and 3+ years of post-degree experience, strong communication, cross-functional #J-18808-Ljbffr Merck & Co.
Vacancy posted 2 days ago
Similar jobs that could be interesting for youBased on the GMP Instrument Validation Specialist | 21 CFR 11 & SDLC in Rahway, NJ vacancy
- MSD Malaysia is seeking a Metrology and Validation Specialist at our Rahway, New Jersey facility. You will oversee onboarding, qualification, validation... ..., and ongoing calibration of analytical equipment within a GMP framework, contributing to a culture of quality across the...Suggested
- Merck & Co. Rahway, NJ is seeking a Metrology and Validation Specialist to join the Analytical Capabilities & Operations team. This role oversees... ..., and routine maintenance of analytical equipment within a GMP environment. The successful candidate will collaborate with cross...SuggestedPermanent employment
- ...preparing and executing test documentation for GMP computerized systems as well as... ...should have excellent understanding of 21 CFR Part 11, ICH standards, EMA and FDA (GxP) regulations... .... * Coordinate with multi-disciplinary validation team and be responsible for the...Suggested
$142.4k - $224.1k
...qualification and computer system validation activities, and quality... ...of laboratory instrumentation and metrology equipment... ...Laboratories21 CFR Part 820 (Quality Management... ...Management System Regulation)21 CFR Part 4 (... ...posting is effective until 11:59:59PM on the day BEFORE...SuggestedFull timeFor contractorsLocal area- ...increasing productivity.Additional requirement:"Strong expertise in Computer System Validation (CSV) processes and methodologies, ensuring compliance with regulatory standards such as FDA 21 CFR Part 11, GxP, and healthcare-specific requirements.Proficiency in validating SAP...Suggested
- ...Description 0065V6421 CSV Engineer (Laboratory)/Validation Engineer 2 Consultant Please... ...of ELLA and Synergy Neo2 laboratory instruments. The ideal candidate should have hands... ...GxP compliance, data integrity, and 21 CFR Part 11 considerations as applicable...For contractorsLocal area
Two River Consulting Partners
Summit, NJa month ago - ...PURPOSE AND SCOPE OF POSITION: The Specialist, MS&T Manufacturing Systems... ...knowledge of Manufacturing Systems, SDLC methodologies, Computer System Validation (CSV), Computer System Assurance (... ...writing skills. Basic knowledge of GMP manufacturing. Basic knowledge of...Work experience placementWork at officeFlexible hours
$96.2k - $151.4k
....Participates & provides inputs on site selection and validation activities.Performs remote and on-site monitoring & oversight... ...:YesHazardous Material(s):n/aJob Posting End Date:08/21/2026*A job posting is effective until 11:59:59PM on the day BEFORE the listed job posting end...Full timeFor contractorsLocal areaRemote workFlexible hours2 days per week3 days per week$142.4k - $224.1k
...equipment qualification, and computer system validation activities, and quality system... ...and lifecycle management of laboratory instrumentation, monitor environmental controls and coordinate... ...ISO 13485, ISO 14971, ISO/IEC 17025, 21 CFR Part 820, 21 CFR Part 4, 21 CFR Parts 2...For contractors- ...seeking a dedicated professional for drug substance process development in their DSD kilo-lab facility. The ideal candidate will manage GMP and non-GMP processing while ensuring compliance with safety standards. Responsibilities include executing batch manufacture,...
- 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...
$1,814 per week
...the Position Travel Laboratory: Medical Laboratory Technician Elizabeth, NJ Location: Elizabeth, NJ Start Date: 9/14/2026 Shift Details: 8H Nights (11:00 PM-7:00 AM) 38 hours per week Length: 13 WEEKS 13 weeks Apply for specific facility details.MLT...Full timeContract workShift workNight shiftTriage Staffing LLC
Elizabeth, NJ1 day ago- ...Validation Specialist, Computerized SystemsThe Validation Specialist, Computerized Systems, is responsible for performing initial and routine... ...responsibilities include: qualification of laboratory instruments, setup of computers and instruments, troubleshooting of system...Work experience placement
Omni Inclusive
Warren, NJ2 days ago - Job ID: 20867605Reference Number: 23-01958Title: Test automation EngineerLocation: Iselin, NJ, 08830Posted Date: 2023-11-22Company: HAN StaffingTest automation Engineer
- Job ID: 22476941Reference Number: 24-00534Title: Design Verification EngineerLocation: Iselin, NJ, 08830Posted Date: 2024-06-26Company: HAN StaffingDesign Verification Engineer
$87.3k - $137.4k
...build (FLEx Sterile2).The Specialist, Automation... ...automation systems in a validated, compliant state per cGMP... ...and virtualization in GMP operations.Collaborate... ...Troubleshoot across controls, instrumentation, electrical, software,... ...is effective until 11:59:59PM on the day...Full timeContract workFor contractorsLocal areaWorldwideFlexible hoursShift workAfternoon shift- ...Strong leadership and team management experience Knowledge of FDA and USDA regulations Flexibility to support both shifts and weekends as needed Schedule: Two shifts (6:00a-2:30p and 2:30p-11:00p), coverage shared with a second QA Manager. Flexibility required....Shift workWeekend work
HIKINEX
Woodbridge, NJa month ago - MEDVACON in Edison, New Jersey is seeking contractors for cGMP Quality Compliance Validation roles in a pharmaceutical setting. The company collaborates with leading pharmaceutical firms and offers positions available for W2 or direct 1099. Candidates with prior consulting...Permanent employmentContract workFor contractorsRemote work
- ...graduate who enjoys working hands-on with advanced scientific instrumentation? Do you want to contribute to research that supports life-... .../FLD and related analytical equipment Support equipment validation and system performance verification Install and configure...Permanent employmentTemporary workFor contractorsInternshipH1bWork at officeLocal areaWorldwideVisa sponsorship
QPS, LLC
Newark, NJ16 days ago - ...The Laboratory Operations Specialist is responsible for end to end... ...consumables and chemical inventory, instrument maintenance and calibration,... ...efficient, safe, and compliant with GMP and site requirements. In... ...offers all employees who are 21 years of age or older the...Permanent employmentFull timeContract work
Synectics Inc
New Brunswick, NJ5 days ago $139.91k - $172.55k
...and improve NPI success Partner with Supplier Quality and Hardware teams to integrate Design for Inspection (DFI) principles, validating functional gauges and fixtures before tooling kick-off Act as a mentor and educator, developing technical training programs...Full timeTemporary workLocal areaOverseasPeloton
Linden, NJ4 days ago$39.98 - $49.21 per hour
...Laboratory SOPs and certified methods to produce valid and repeatable results. Interpret and... ...JOB FUNCTIONS Operate laboratory instruments and apparatus, including analytical balances... ...multitasking skills. Salary Range $39.98 /hr - $49.21/hr based on experience #J-18808-Ljbffr...Immediate startWeekend work- Medical Laboratory Technician Location: Elizabeth, NJ Agency: Access Healthcare LLC Pay: Competitive weekly pay (inquire for details) Shift Information: Nights - 3 days x 12 hours Contract Duration: 13 Weeks Start Date: 9/14/2026 About ...Weekly payFull timeContract workSummer workImmediate startShift workNight shift3 days per week
Access Healthcare LLC
Elizabeth, NJ1 day ago $1,857 per week
Medical Laboratory Technician Location: Elizabeth, NJ Agency: FlexCare Pay: $1,857 per week Shift Information: Nights - 5 days x 8 hours Contract Duration: 13 Weeks Start Date: ASAP About the Position Position Details Profession:...Full timeContract workImmediate startShift workNight shiftFlexCare
Elizabeth, NJ1 day ago$1,905 per week
Medical Laboratory Technician Location: Elizabeth, NJ Agency: AHS Staffing Pay: $1,905 per week Shift Information: Nights - 5 days x 8 hours Contract Duration: 14 Weeks Start Date: 9/14/2026 About the Position AHS Staffing is looking...Full timeContract workShift workNight shiftAHS Staffing
Elizabeth, NJ19 hours ago$2,102 per week
Medical Laboratory Technician Location: Elizabeth, NJ Agency: Pride Health Pay: $2,102 per week Shift Information: 5 days x 7 hours Contract Duration: 13 Weeks Start Date: 9/14/2026 About the Position A Medical Technologist performs ...Full timeContract workShift workPride Health
Elizabeth, NJ1 day ago$1,173 - $1,235 per week
Medical Laboratory Technician Location: Elizabeth, NJ Agency: Specialty Professional Services Pay: $1,173 to $1,235 per week Shift Information: Nights Contract Duration: 13 Weeks Start Date: 9/14/2026 About the Position Our Client is...Extra incomeFull timeContract workShift workNight shiftSpecialty Professional Services
Elizabeth, NJ1 day ago$2,101 per week
Medical Laboratory Technician Location: Elizabeth, NJ Agency: MedPro Healthcare Staffing Pay: $2,101 per week Shift Information: 5 days x 8 hours Start Date: ASAP About the Position MedPro Healthcare Staffing , a Joint Commission-certified...Hourly payWeekly payContract workImmediate startShift workMedPro Healthcare Staffing
Elizabeth, NJ1 day ago- Job ID: 21108318Reference Number: 24-00073Title: Test Automation Engineer X-WAPLocation: Iselin, NJ, 08830Posted Date: 2024-01-16Company: HAN StaffingTest Automation Engineer X-WAP
- Siemens Healthineers is seeking a Metrology Technician to join the Glasgow, DE site. You will perform calibrations on commercial and R&D equipment, maintain GDP-compliant logs, and collaborate with vendors to source parts and schedule service. You will read schematics and...
Do you want to receive more vacancies?
Subscribe and receive similar vacancies to GMP Instrument Validation Specialist | 21 CFR 11 & SDLC. Be the first to apply!
