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Oracle OPM Consultant at Albany, New York

SAR TECH LLC

•

Albany, New York, USA

Contract

Hi PFA below requirement and let me know your interested Job title:Oracle OPM Consultant Location:Albany, New York Duration: Contract JD - Job Description-The Oracle OPM Consultant will be responsible for the managing the support project including but not limited to implementation, configuration, and ongoing support of Oracle Process Manufacturing (OPM) modules within the pharmaceutical manufacturing environment. The role requires expertise in Oracle OPM and its integration with other Oracle m
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Posted 17 days ago

Experienced Data Scientist

Johnson & Johnson

•

Danvers, Massachusetts, 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
Posted 8 days ago | Updated 4 hours ago

Proposal Writer / Proposal Development Specialist

ExpediteInfoTech, Inc.

•

Rockville, Maryland, USA

Full-time, Contract

Position Summary : The Proposal Writer / Proposal Development Specialist supports the proposal and business development teams in growth activities. This position involves conducting research, proposal writing and content development. Experience in creating compliant proposal responses to Federal solicitations is required. Candidates should have experience collaborating with various stakeholders to develop win themes and value propositions and providing essential proposal development process su
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Posted 60+ days ago | Updated moments ago

Windchill Consultant

Teknikoz

•

Sunnyvale, California, USA

Contract, Third Party

PTC Arena Consultant Job Description:We are seeking a skilled and proactive PTC Arena Consultant with a minimum of 3 years of hands-on experience in Arena PLM/QMS systems. The ideal candidate will play a key role in supporting, configuring, and enhancing Arena PLM to meet our product development and compliance needs. You will collaborate with cross-functional teams including Engineering, Quality, Regulatory, and Manufacturing to ensure smooth implementation and ongoing optimization of Arena s
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Posted 2 days ago

Technical Proposal Solutions Architect

ExpediteInfoTech, Inc.

•

Rockville, Maryland, USA

Full-time, Contract

Summary: As the Technical Proposal Solutions Architect for ExpediteInfoTech, Inc. (EIT), you will lead overall technical solutions for RFIs, RFPs, RFXs, SSNs, including for IDIQs, BPAs, GWACs, Task Order contracts and technical marketing material including white papers. Providing technical strategies, solutions, and forward-looking advisory services are just a few of the exciting responsibilities of this position.The successful candidate will possess a broad base of core technical knowledge and
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Posted 60+ days ago | Updated moments ago

Regulatory Specialist

NavaTech LLC

•

Maryland, USA

Third Party, Contract

Regulatory Specialist Location: Hybrid: 2 4 Days Onsite presence required in Leesburg or Tysons, VA (Subject to change) This is a contract-to-hire position. Job Description: Regulatory Affairs Specialist with a strong understanding of FDA regulatory processes for drugs, medical devices, or both. The ideal candidate will serve as a Subject Matter Expert (SME), offering in-depth guidance on the end-to-end regulatory lifecycle, including pre-submission planning, documentation requirements, and f
Posted 2 days ago | Updated 2 days ago

QA Compliance Specialist

Aroha Technologies

•

Carlsbad, California, USA

Contract, Third Party

Job Title: QA Compliance Specialist Contract Duration: 6+ Months (Renewable) Location: Onsite Carlsbad, CA Must have: GMP-regulated biopharmaceutical environment, QMR, APQR, FDA/ICH/EU cGMP Description: GMP Experience Minimum 8+ years in a GMP-regulated biopharmaceutical environment Quality Assurance Experience At least 2+ years specifically in a QA role QA Compliance Knowledge Strong knowledge of QA Compliance systems including: Quality Management Review (QMR) Annual Product Qua
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Posted 2 days ago | Updated 20 hours ago

Engineer III, Systems Engineer

Katalyst Healthcares and Lifesciences

•

San Diego, California, USA

Full-time

Responsibilities: Verification & validation Engineer will have the following responsibilities: A strong technical background and experience g in the medical device industry (Translation of User/Business Needs to System Requirements, Requirements Management, System Architectural Development, Functional Modeling, Systems Integration, Statistical Test Design, Verification and Validation, Hazards Analysis, and Failure Modes Effects Analysis), and/or other engineering disciplines within the medical
Posted 15 days ago | Updated 4 hours ago

SAP GTS Business Function Implementation Lead (Remote Work)

Source Code Technologies LLC

•

Remote

Third Party, Contract

We are seeking an experienced SAP GTS Consultant with expertise in Global Trade Services (GTS), including full lifecycle implementations and hands-on configuration in SAP GTS E4H. The ideal candidate will have deep functional knowledge of compliance management, customs processes (exports/imports), and GTS master data, particularly in trade between the Dominican Republic (DR) and the US.This is a client-facing, lead role requiring strong project leadership, ability to drive results, and hands-on
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Posted 5 days ago

Quality Technician

Select Source International

•

Port Allen, Louisiana, USA

Contract

Title Quality Technician Location Port Allen, LA Duration 6+ months contract Essential Functions If starting position is in incoming laboratory and in-process inspections: Performs area clearances/line clearances, in-process inspections of manufacturing processes, and inspection and disposition of incoming material. Monitors manufacturing process performance as relates to SPC/SQC, general compliance status of manufacturing and warehouse areas, as well as ensures components, product or equipme
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Posted 3 days ago | Updated 14 hours ago

Documentation Specialist

LanceSoft Inc.

•

Athens, Georgia, USA

Contract

Job Title: Documentation Specialist Location : Athens GA 30601 Duration : 12 months Duties: Tech-savvy information management specialist to support GI Development sites / activities.Major activities include: the subject matter expert for electronic document management systems and migration of records from legacy systems.Electronic Document Management (controlled documents, regulatory submission documents): Create and configure document templates and support site users in workflow configuration.
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Posted 2 days ago

Senior Post Market Engineer

Katalyst Healthcares and Lifesciences

•

Gainesville, Florida, USA

Full-time

Roles & Responsibilities: Bachelor's Degree in an Engineering discipline from an accredited institution required. Complaint product analysis and testing per procedures and requirements. Root cause analysis and supports conclusions with objective evidence and sound rationale. Complaint risk analysis and complaint history reviews. Knows and applies Quality System requirements and any appropriate FDA and international standards. Must have an understanding of root cause and risk analysis as wel
Posted 60+ days ago | Updated 4 hours ago

Engineer Disposables and Sustaining

Katalyst Healthcares and Lifesciences

•

Plymouth, Minnesota, USA

Full-time

Responsibilities: Create new 3rd party supplier documentation including design specifications, labelling, design drawings, etc. for peritoneal dialysis disposable sets. Create, modify, and maintain design history files. Perform change control assessments. Work closely with project manager and technical lead to achieve project commitments. Adhere to design control procedures, general safety rules, company policies and procedures, FDA and international regulations and guidance. Requirements:
Posted 1 day ago | Updated 4 hours ago

Senior Consultant Life sciences Domain

Nityo Infotech Corporation

•

Indianapolis, Indiana, USA

Full-time

Job Role; Senior Consultant Life sciences Domain Job Type: Full Time Job location: Indianapolis, IN Job Description: Client is seeking Life Sciences Domain Consultant. As a commissioning and Qualification consultant you will be the leading validation activities for clients and might also be involved handling IT Compliance audits and assurance and supporting external inspections from Regulatory bodies like FDA, MHRA, European Health Commission, Health Canada, etc. Required Qualifications: Candid
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Posted 11 days ago

System Validation Engineer

Katalyst Healthcares and Lifesciences

•

Santa Clara, California, USA

Full-time

Responsibilities: Develop, implement, and maintain software quality assurance processes for non-product software used in medical device development. Ensure adherence to regulatory standards (FDA, ISO 13485, IEC 62304) and industry best practices for non-product software. Support audits and inspections by regulatory bodies, ensuring that non-product software systems comply with quality and documentation standards. Ensure computerized systems are appropriately validated Assessment of applicabi
Posted 1 day ago | Updated 4 hours ago

Medical Device Engineer

Katalyst Healthcares and Lifesciences

•

North Chicago, Illinois, USA

Full-time

Responsibilities: Develop, implement, and maintain software quality assurance processes for non-product software used in medical device development. Ensure adherence to regulatory standards (FDA, ISO 13485, IEC 62304) and industry best practices for non-product software. Support audits and inspections by regulatory bodies, ensuring that non-product software systems comply with quality and documentation standards. Ensure computerized systems are appropriately validated Assessment of applicabi
Posted 2 days ago | Updated 4 hours ago

Packaging Engineer (Medical Devices)

Intellectt INC

•

Memphis, Tennessee, USA

Contract, Third Party

Role Summary: We are seeking a hands-on Packaging Engineer to support and lead medical device packaging development projects-focused on spinal implants and surgical instruments. The role involves managing OEM packaging activities and ensuring compliance with FDA, ISO, and MDR (EU) standards, especially for sterile packaging. This is a project-execution-driven role requiring strong cross-functional collaboration, risk management, and design documentation expertise. Top Required Skills: Sterile M
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Posted 5 days ago | Updated 1 day ago

Medical Device & Regulations Engineer

Katalyst Healthcares and Lifesciences

•

Santa Clara, California, USA

Full-time

Responsibilities: Develop, implement, and maintain software quality assurance processes for non-product software used in medical device development. Ensure adherence to regulatory standards (FDA, ISO 13485, IEC 62304) and industry best practices for non-product software. Support audits and inspections by regulatory bodies, ensuring that non-product software systems comply with quality and documentation standards. Ensure computerized systems are appropriately validated Assessment of applicabil
Posted 6 days ago | Updated 4 hours ago

Senior Validation Engineer

Katalyst Healthcares and Lifesciences

•

Lexington, Massachusetts, USA

Full-time

Responsibilities: Shire Human Genetic Therapies Inc. is seeking a Senior Validation Engineer with the following duties: Write Validation documents per Food Drug Administration (FDA)/Company guidelines; draft Specification documents and Validation Plans (VPs) for pharmaceutical manufacturing and laboratory equipment; Write and execute qualification protocols for new equipment and decommissioning protocols for old equipment. Execute approved protocols per company Good Documentation Practices (cG
Posted 1 day ago | Updated 4 hours ago

Clinical SAS Programmer

Katalyst Healthcares and Lifesciences

•

Princeton, New Jersey, USA

Full-time

Responsibilities: Effectively designs and codes SAS programs using BASE/SAS, SAS/STAT, SAS/GRAPH and SAS MACROS for assigned clinical projects(s). Produces and delivers CDISC and regulatory compliant SDTM, and ADaM standard datasets. Creates and validates tables, figures and listings (TFLs) in a timely and high-quality fashion, consistently meeting objectives of the study, and regulatory requirements. Provides input in the design and development of case report forms and clinical databases.
Posted 7 days ago | Updated 4 hours ago