Computer System Validation Engineer Job at TK-CHAIN LLC, Princeton, NJ

YWZSU0pJTXc2UDQrNjhwV1F1bUc5d29WQkE9PQ==
  • TK-CHAIN LLC
  • Princeton, NJ

Job Description

Job Description

Job Description

Responsibilities

Lead the design, development, implementation, and execution of test scripts/test plans to identify software problems and their causes.
Coordinate and execute performance and functional testing associated with multiple concurrent development and/or infrastructure projects.
Perform testing of the entire SDLC, including version/change control and new software rollouts.
Develop releases on multiple platforms to ensure that all code released to production systems meet or exceed pre-defined quality standards.
Author and execute Installation and Operational Qualification (IQ/OQ) protocols and reports for pharmaceutical manufacturing, packaging equipment and utilities equipment.
Assist in the design and procurement of new process and utility equipment and lead installation, start-up and commissioning or qualification activities.
Author IQ/OQ protocols for new or used equipment purchased.
Review IQ/OQ protocols provided by equipment manufacturers to ensure compliance with site procedures.
Utilize knowledge of all phases of Software Project Development Life Cycle and broad contribution to Analysis, Design, Development, Testing and Deployment of Software Applications.
Ensure that the testing is sufficient to meet regulatory requirements (21 CFR Part 11, ISO 13485, ISO 14971).

Requirements

BS in Engineering, Science, or equivalent technical degree.
7+ years experience in a regulated, manufacturing environment within the biotechnology, pharmaceutical or medical device industry.
Excellent written and verbal communication skills; excellent technical writing skills.
Strong interpersonal skills and the ability to work in a team environment.
Ability to work effectively in a fast-paced multitasking environment.
Strong working knowledge of FDA and cGMP regulations and documentation practices.
Proficient in Microsoft Word, Excel, PowerPoint.

Job Tags

Similar Jobs

MRL Consulting Group - the semiconductor recruitment company

Business Development / Account Manager Job at MRL Consulting Group - the semiconductor recruitment company

 ...company specializing in Power ICs. In this role, you will play a key part in driving business growth across the HPC, Industrial, Automotive, and Consumer markets. This is a fast-growing opportunity for a highly ambitious and driven individual. Must be able to... 

Confidential

Physician / Critical Care / Connecticut / Locum or Permanent / PulmonaryCritical Care Intensivist opening in southwest of Hartford, CT Job Job at Confidential

Health System is seeking a BC/BE Physician that is fellowship trained in Critical Care and Pulmonary Medicine to join a highly skilled and collegial team in northwest Connecticut. Practice the full scope of Pulmonology and Critical Care Medicine in a professionally and...

Steadfast

Administrative Assistant - Bilingual (Spanish English) Job at Steadfast

Steadfast is looking to hire a Bilingual (Spanish amp; English) office assistant. The ideal candidate will have the ability to work in a fast-paced working environment with ability to multi-task. The candidate for this position should have exceptional customer service... 

Drafter Valdez LLC

Structural Engineer Job at Drafter Valdez LLC

 ...practical, high-quality designs that fit their needs and budget. Role Description This is a contract, remote role for a Structural Engineer at Drafter Valdez LLC. The Structural Engineer will be responsible for calculations, structural analysis, structural... 

Two95 International Inc.

Sr.IOS Developer - Remote Job at Two95 International Inc.

 ...Hi, Title Sr. IOS Developer Position Contract (3+ Months) with Extensions Location Remote Rate - $Open(Best Possible) RESPONSIBILITIES Replicate the Android UI and back-end functionality in an iOS application Work with...