Responsibilities :
- Responsible for performing validation of computer systems, process automation, equipment, utility systems, and / or facilities by following approved standard operating procedures (SOPs), current Good Manufacturing Practices (GMPs) and all other regulatory requirements including GAMP5.
- Executes test plans according to approved procedures, collects samples, tabulates test results, and organizes data packages.
- Compiles and analyses validation data, prepares reports and makes recommendations for changes and / or improvements.
- May also investigate and trouble-shoot problems which occur and determine solutions.
- Coordinates and executes validation change control and preparation of draft protocols, reports and data tables.
- Maintains all documentation pertaining to validation.
- Will assist in developing procedures and / or protocols.
- Coordinates contract personnel through completion of assignments.
- Participates on cross-functional project teams with the support of Development, Manufacturing, Engineering, Quality, and other groups as required.
Requirements :
- Understanding and application of validation principles, concepts, practices, and standards. - 8+ years
- Working knowledge of current Good Manufacturing Practices (GMPs).
- Previous experience with Computer System Validation (CSV) and experience with System Development Life Cycle of automated computer systems within biopharmaceutical environments.
- 6+ years qualifying infrastructure and OT networks.
- Working knowledge of validation of process control (PCS) and data acquisition systems is preferred.
- Strong verbal, written, and interpersonal communication skills.
- Proficient in Microsoft Office applications.
- 6 of 8 skills match your profile - you may be a good fit.
- Requirements added by the job poster.
- 6+ years of work experience with Data Validation.
- 6+ years of work experience with Infrastructure.
- 6+ years of work experience with Data Acquisition.
Validation Engineer, Infrastructure Qualification
Responsible for performing validation of computer systems, process automation, equipment, utility systems, and/or facilities by following approved standard operating procedures (SOPs), current Good Manufacturing Practices (GMPs) and all other regulatory requirements including GAMP5. Compiles and ana...
Senior Software Engineer
Delaware Avenue (18052), United States of America, Wilmington, DelawareSenior Software EngineerDo you love building and pioneering in the technology space? Do you enjoy solving complex business problems in a fast-paced, collaborative, inclusive, and iterative delivery environment? At Capital One, yo...
Senior Quality Assurance Engineer
As a Quality Assurance Engineering Specialist in the pharmaceutical industry, you will play a critical role in ensuring the quality and compliance of our products throughout the development and manufacturing processes. Quality Assurance Engineering Specialist. Minimum 2-3 years of experience in qual...
Python Software Engineer - Ubuntu Hardware Certification Team
We work at the interface of hardware and software, so the ideal candidate is a Python developer familiar with hardware. We design hardware which can be used to probe devices independently, and frameworks for software tests that check every aspect of Ubuntu on that hardware. We are looking for a self...
Process Engineer
Engineers new and modifies existing processes to ensure right first time process start up. Experience in engineering, with less focus on development or operations/manufacturing, and a stronger background in engineering. A minimum of eight (8) years of process/plant engineering experience in GMP MFG ...
Manufacturing Engineer
Our Consumer Manufacturing Client is seeking an Engineer 2 to join their team in Fort Washington, PA!. This individual will be a part of an exciting opportunity with bringing two new manufacturing lines into the site. They will be involved from design, planning, selection, installation, development,...
Lead Quality Assurance Engineer
Are you passionate about pioneering automation in quality assurance? Do you thrive in environments where building from the ground up excites you? Join us as our Lead QA Engineer where you'll play a pivotal role in transforming our testing landscape. Shape the future of our QA processes, drive innova...
WiFi Performance Test Engineer
Wi-Fi Performance Testing Engineer. In this role, you will work closely with development engineers, vendors, and stakeholders to create test plans, troubleshoot issues, and ensure high-quality Wi-Fi functionality. Collaborate with engineers to understand new features and create test cases. This posi...
Senior Quality engineer -Laser Tracker and ARM Operator
Looking for an Senior Quality engineer -Laser Tracker and ARM Operator, Please find a job description below, And reach me on bk. Job Title: (Senior Quality engineer -(Laser Tracker and ARM Operator). In this role, the Engineering Technologist will work under the direction of the Quality Manager cond...
Quality Assurance Engineer
EPM Scientific are looking for a experience Quality professional to fill a vacancy on a 1 year contract for a Medical Device client of ours! The Quality Engineer will play a critical role in ensuring the quality and compliance of our medical devices. Develop and implement quality assurance protocols...