GMP Jobs in New York

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GXP Project Manager

Spark Infotech

Remote

Contract

Requirement: - 8+ years full lifecycle PM experience - Demonstrated PMLC/SDLC experience/success - Ability to quickly adapt to a maturing project environment - Ability to manage multiple concurrent priorities - MS Project and the ability to execute project plan is a must have - GXP & GMP Experience Plus: - GMP project experience, preferably as a PM - PMP certification - Experience with Planview and ProjectPlace - Validation experience

QA CTO Label Specialist

LOGIXtech Solutions

Summit, New Jersey, USA

Contract

Our client, a leading pharmaceutical company, is hiring a QA CTO Label Specialist, on a contract basis. Job ID: 83032 Work Location: Summit, NJ - 100% on site Education/Experience: B.S. Degree required, 2 years relevant work experience Must have knowledge and experience with GMP, Quality, and compliance. Able to write and review technical reports with clarity and brevity; provides guidance to other team members in technical writing skills. Requires moderate direction to complete more complex tas

QA CTO Label Specialist

TSR Consulting Services, Inc.

Summit, New Jersey, USA

Contract

Our client, a leading pharmaceutical company, is hiring a QA CTO Label Specialist, on a contract basis. Job ID: 83032 Work Location: Summit, NJ - 100% on site Education/Experience: B.S. Degree required, 2 years relevant work experience Must have knowledge and experience with GMP, Quality, and compliance. Able to write and review technical reports with clarity and brevity; provides guidance to other team members in technical writing skills. Requires moderate direction to complete more complex tas

CSV Engineer

Katalyst Healthcares and Lifesciences

Nutley, New Jersey, USA

Full-time

Job Description: Looking for someone who has done Validation.Google Cloud Platform and CSV. Must understand the business of clinical. We are seeking a versatile professional with the ability to review documents meticulously and support the creation of validation deliverables as needed. The ideal candidate will thrive in a challenging environment and possess the skills to effectively communicate the importance of validation processes to stakeholders outside the validation team. Responsibilities:

Automation Control Engineer

Katalyst Healthcares and Lifesciences

South Plainfield, New Jersey, USA

Full-time

Responsibilities: Support design reviews, debugging, acceptance, and validation of equipment developed by external suppliers. Assist in decommissioning and recommissioning of equipment to ensure proper functionality and compliance. Conduct and analyze Gauge Repeatability & Reproducibility (GR&R) studies and Process Capability assessments. Work with automation control systems, including PLCs, HMIs, Vision Systems, Servos, and Robots. Develop and optimize programs for Allen-Bradley/Rockwell Automa

Raw Materials Technical Specialist

Aditi Consulting

Remote or Cambridge, Massachusetts, USA

Contract

Payrate: $38.00 - $40.00/hr. Summary: The ideal candidate will have a strong background in documentation and regulatory specification development within a GMP-compliant environment. They should bring experience in project management and raw material specification, ideally from pharmaceutical, biotech, or similarly regulated industries (such as aerospace or chemical engineering). The role is fully remote and requires someone who can work independently with minimal supervision while contributing t

IBM Maximo EAM Specialist

Transcend IT Solutions

Remote

Contract, Third Party

Position Title: IBM Maximo EAM Specialist Location: 100% Remote (East Coast is preferred,Duration: 6+ Months Job Details:MUST HAVE PAST THERMO FISHER EXPERIENCE! Maximo Experience is not the only key skill sets for the positions. Experience in Pharma/ Bio Tech is a MUST Maximo Life Science Industry Solution ExpertiseFDA regulatory experiencePharma validation, change managed, calibration data sheets for life sciencesSignature reference using FDA guidelinesGMP experienceTFS key application experie

Senior Engineer, Pharmaceutical Operations Engineering

Merck & Company Inc

Rahway, New Jersey, USA

Full-time

Job Description This Senior Engineer position will provide engineering support to the Rahway, NJ FLEx (Formulation, Laboratory & Experimentation) center, primarily for sterile operations under the remit of Our Company's Research Labs Pharmaceutical Sciences (Pharm Sci), Pharmaceutical Operations Engineering group (Pharm Ops Engineering). The role is on-site and reports to the Sterile Pharm Ops Engineering Lead of the FLEx GMP facility within Pharmaceutical Operations and Clinical Supply (PSCS)

Sr. Spclst , Technical Support

Merck & Company Inc

Remote or Rahway, New Jersey, USA

Full-time

Job Description Business Technology Partner Our IT team operates as a business partner proposing ideas and innovative solutions that enable new organizational capabilities. We partner internationally to deliver the services and solutions that help development scientists to be more productive and enable innovation. The BTP ensures translation of business strategy to IT strategy, relevant communication to business and IT functions, and develop strategic digital roadmaps, and lead delivery of ca

Senior Director IT Quality Assurance & Compliance

Regeneron Pharmaceutical

Remote or Sleepy Hollow, New York, USA

Full-time

As a Senior Director of IT, Quality Assurance and Compliance, you will lead a team of those managing 20 to 30 members The focus is to provide leadership, coaching, and technical support to the IT QA & Compliance Management Team. This role is an on-site position 4 days/week at our Sleepy Hollow, NY or Warren, NJ office. There will be occasional travel to other sites in the Rensselaer, NY area. If eligible, we can offer relocation benefits. We are unable to offer a fully remote option. A typical

Process Development Engineer II - Synthetic and Bioconjugation Scale-Up

Regeneron Pharmaceutical

Tarrytown, New York, USA

Full-time

Regeneron's Preclinical Manufacturing & Process Development group (PMPD), located in Tarrytown NY, is seeking a hardworking and dynamic Process Development Engineer II for its new Synthetic and Bioconjugation Scale-up Technologies (SBST) group. In this exciting new role, you will develop conjugation and purification processes for bioconjugation of proteins to a diverse range of small-molecules. You would work in close collaboration with cross-functional teams for process development and optimiza

Engineer II, Field Service

Thermo Fisher Scientific

Pearl River, New York, USA

Full-time

Work Schedule Standard (Mon-Fri) Environmental Conditions Adherence to all Good Manufacturing Practices (GMP) Safety Standards, Fluctuating Temps hot/cold, Laboratory Setting, Loud Noises (Equipment/Machinery), Standing for full shift, Strong Odors (chemical, lubricants, biological products etc.), Various outside weather conditions Job Description Engineer II, Field Service Location: Pearl River, NY - Pfizer Job Description: When you join us at Thermo Fisher Scientific, you'll be part of a

GIE PPD Staff Engineer I Molding

Becton Dickinson & Company

Franklin Lakes, New Jersey, USA

Full-time

Job Description Summary The molding Engineer is leading and coordinating the process development activity to support new product development projects from the innovation phase to the first commercial batches. In this role the molding engineer will influence product and process design & ensure manufacturability of products. The target being to develop superior product design efficient manufacturing process for highest quality and lowest cost. Job Description We are the makers of possible BD is

Process Engineer

Katalyst Healthcares and Lifesciences

Remote or New York, USA

Full-time

Responsibilities: Senior Process Engineer responsible for tech transfers within the manufacturing team. Support GMP-related activities. Experience in tech transfer and project management. Strong technical skills, including report writing and problem-solving. Excellent communication skills, with the ability to clearly relay technical information. Cell Therapy (CAR-T) experience (preferred). Willingness to travel (approximately 25%). t least 5 years of relevant experience.

Field Service Engineer I (lab equipment)

Thermo Fisher Scientific

Colorado, USA

Full-time

Work Schedule Other Environmental Conditions Able to lift 40 lbs. without assistance, Adherence to all Good Manufacturing Practices (GMP) Safety Standards, Cold Room/Freezers -22degreesF/-6degrees C, Fluctuating Temps hot/cold, Laboratory Setting, Some degree of PPE (Personal Protective Equipment) required (safety glasses, gowning, gloves, lab coat, ear plugs etc.) Job Description Field Service Engineer (lab equipment) When you join us at Thermo Fisher Scientific, you'll be part of an inquis

Staff Software Engineer, Manufacturing Engineering

Thermo Fisher Scientific

Remote or Atlanta, Georgia, USA

Full-time

Work Schedule Standard (Mon-Fri) Environmental Conditions Adherence to all Good Manufacturing Practices (GMP) Safety Standards, Office, Some degree of PPE (Personal Protective Equipment) required (safety glasses, gowning, gloves, lab coat, ear plugs etc.) Job Description About Us: At Thermo Fisher Scientific, our mission is to enable our customers to make the world healthier, cleaner, and safer. We are revolutionizing the manufacturing industry with brand new technology and innovative solutio

Sr Technical Operations Training & Support Specialist

Thermo Fisher Scientific

Remote or Greenville, North Carolina, USA

Full-time

Work Schedule Flex Shifts 40 hrs/wk Environmental Conditions Adherence to all Good Manufacturing Practices (GMP) Safety Standards, Loud Noises (Equipment/Machinery), Office, Some degree of PPE (Personal Protective Equipment) required (safety glasses, gowning, gloves, lab coat, ear plugs etc.) Job Description Position Summary: Join Thermo Fisher Scientific Inc. as a Sr Technical training and support engineer and have the unique opportunity to build, grow, and share your expertise in the manuf

Technical Operations Training & Support Specialist

Thermo Fisher Scientific

Remote or Greenville, North Carolina, USA

Full-time

Work Schedule Flex Shifts 40 hrs/wk Environmental Conditions Adherence to all Good Manufacturing Practices (GMP) Safety Standards, Cleanroom: no hair products, jewelry, makeup, nail polish, perfume, exposed piercings, facial hair etc allowed, Office, Some degree of PPE (Personal Protective Equipment) required (safety glasses, gowning, gloves, lab coat, ear plugs etc.) Job Description Position Summary: Join Thermo Fisher Scientific Inc. as a Technical training and support engineer and have th

Senior Commissioning, Qualification & Validation (CQV) Engineer

Johnson & Johnson

Remote or Athens, Georgia, USA

Full-time

At Johnson & Johnson, we believe health is everything. Our strength in healthcare innovation empowers us to build a world where complex diseases are prevented, treated, and cured, where treatments are smarter and less invasive, and solutions are personal. Through our expertise in Innovative Medicine and MedTech, we are uniquely positioned to innovate across the full spectrum of healthcare solutions today to deliver the breakthroughs of tomorrow, and profoundly impact health for humanity. Learn m

Compliance Lead

Adva IT Services, Inc..

Remote

Contract

Key Responsibilities Lead the design and execution of the company s compliance framework, covering GxP areas (GMP, Google Cloud Platform, GLP) and validated system lifecycle activities. Ensure compliance with SDLC processes for GxP-relevant computerized systems, including documentation, validation, change control, and audit readiness. Develop and maintain SOPs and training programs related to software/system validation and data integrity (e.g., per 21 CFR Part 11 and Annex 11). Provide complianc