LanceSoft IncWest Point (PA)
in multiple locations for accuracy post system migration
" Participate in computer system validation activities associated with new or upgraded equipment or software packages.
" Support the purchase, installation, and equipment qualification of new...
Macpower Digital Assets Edge Private Limited (MDA Edge)West Pittsburg (PA)
prior to the verification and validation phase.
While having our own responsibilities within the group, we look to each other's strengths for support in doing our jobs.
Roles & Responsibilities:
Learn from and adhere to internal quality manual...
Katalyst Healthcares & Life SciencesPittsburgh
demonstrations and work with end-users to insure user requirements are met.
Execute commissioning; support validation team's installation qualification (IQ), operational qualification (OQ), and performance qualification (PQ) activities.
Function...
Katalyst Healthcares & Life SciencesKing of Prussia
Responsibilities:
Must have 12+ years of experience in GxP validation testing on pharmaceutical domain.
3 + years of experience in managing testing projects in multiple towers.
Experience in test effort estimation & resources planning across all...
Disney Entertainment & ESPN TechnologyPhiladelphia
We are looking for an experienced backend services focused Software Engineer II to join the Partner Experience Engineering team. Bachelor’s degree in Computer Science, Information Systems, Software Engineering, Electrical or Electronics Engineering, or comparable field of study, and/or equivalent wo...
Bravura Information Technology Systems, IncCarlisle
Monitor systems for disk usage, disk performance, and system performance. Apply current operating system patches and security patches for both local and cloud- based systems. Analyze functional user requirements and current system capabilities to establish plan for adjusting system, plan, test, and ...
ArcfieldKing of Prussia
This position is for a Systems Engineering and Technical Assistance (SETA) within Space and Mission Engineering. Arcfield is a leading provider of full lifecycle, mission-focused systems engineering and integration capabilities to the U. Are you looking to join a company that’s mission focused and i...
ArcfieldKing of Prussia
This position is for a Systems Engineering and Technical Assistance (SETA) within Space and Mission Engineering. Arcfield is a leading provider of full lifecycle, mission-focused systems engineering and integration capabilities to the U. Are you looking to join a company that’s mission focused and i...
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Validation Engineer
Katalyst Healthcares & Life Sciences | Philadelphia | www.resume-library.com |
Responsibilities:
Support all aspects of the Cleaning Validation Life Cycle for clients from development through qualification and monitoring .
Create/author/execute at a minimum , Validation Plans, V-cycle documents, Validation Summary Report, Qualification protocols/reports, and Performance Qualification protocols/reports.
Responsible for the qualification of cleaning manufacturing equipment independently in aseptic filling and GMP areas, including autoclave, Vessel Equipment validation, Sterilization in Place of filling vessels and COP validation in accordance with corporate and departmental procedures.
Participate i n cross-functional project team , including value streams and site support groups to address specific problems, facilitate discussion and research and enable procedures to become more efficient.
Experience with writing and executing Hold Time studies.
Experience with gowning in aseptic classified areas.
Perform all job responsibilities in compliance with applicable EHS and GMP regulations, guidelines, policies, and standard operating procedures.
Perform carry-over calculations and determine cleaning limits. Must have demonstrated self-direct work habits and strong communication skills.
Must be a committed team player prepared to work in and embrace a team-based culture.
Familiarity with regulatory expectations regarding electronic records and electronic signatures.
Ability to work in a high complex matrix environment.
Sense of urgency, flexibility and accountability.
Ability to follow written procedures and document results in a neat and precise manner , following Good Documentation Practices .
Maintain attention to detail, while completing multiple or repetitive tasks.
Demonstrate a serious commitment to accuracy and quality while meeting goals or deadlines.
Maintain a high level of integrity while balancing multiple priorities and responsibilities.
Requirements:
BS in science or engineering.
Minimum of 5 years pharmaceutical/biotech experience in validation with knowledge .
Proficient and experience with Kaye validators and temperature data loggers to independently perform temperature mapping studies for autoclave and Vessel SIP
Proficient and experience with sampling for cleaning validation including independently performing swabbing and taking rinse samples.
Prior experience preparing and executing equipment qualification documents required.
SME experience in the following areas is preferred :
Sterilization Validation (autoclave and vessel SIP)
Support all aspects of the Cleaning Validation Life Cycle for clients from development through qualification and monitoring .
Create/author/execute at a minimum , Validation Plans, V-cycle documents, Validation Summary Report, Qualification protocols/reports, and Performance Qualification protocols/reports.
Responsible for the qualification of cleaning manufacturing equipment independently in aseptic filling and GMP areas, including autoclave, Vessel Equipment validation, Sterilization in Place of filling vessels and COP validation in accordance with corporate and departmental procedures.
Participate i n cross-functional project team , including value streams and site support groups to address specific problems, facilitate discussion and research and enable procedures to become more efficient.
Experience with writing and executing Hold Time studies.
Experience with gowning in aseptic classified areas.
Perform all job responsibilities in compliance with applicable EHS and GMP regulations, guidelines, policies, and standard operating procedures.
Perform carry-over calculations and determine cleaning limits. Must have demonstrated self-direct work habits and strong communication skills.
Must be a committed team player prepared to work in and embrace a team-based culture.
Familiarity with regulatory expectations regarding electronic records and electronic signatures.
Ability to work in a high complex matrix environment.
Sense of urgency, flexibility and accountability.
Ability to follow written procedures and document results in a neat and precise manner , following Good Documentation Practices .
Maintain attention to detail, while completing multiple or repetitive tasks.
Demonstrate a serious commitment to accuracy and quality while meeting goals or deadlines.
Maintain a high level of integrity while balancing multiple priorities and responsibilities.
Requirements:
BS in science or engineering.
Minimum of 5 years pharmaceutical/biotech experience in validation with knowledge .
Proficient and experience with Kaye validators and temperature data loggers to independently perform temperature mapping studies for autoclave and Vessel SIP
Proficient and experience with sampling for cleaning validation including independently performing swabbing and taking rinse samples.
Prior experience preparing and executing equipment qualification documents required.
SME experience in the following areas is preferred :
Sterilization Validation (autoclave and vessel SIP)
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