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

S1ZhTW8xWElSRk90R0JETURJTXNISlNDSGc9PQ==
  • 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

Manatawny SNF

Dietary Aide Job at Manatawny SNF

 ...Job Description Job Description Job Description: Manatawny Manor is looking for Dietary Aides to join our team! As an important member of our team, the Dietary Aide provides assistance in all food service functions to ensure residents dining needs are met in accordance... 

Uncommon Schools

Suzuki Strings Instructor Job at Uncommon Schools

 ...standards; ~ Develop music literacy lesson components related to teaching rhythm and pitch notation, solfege reading and singing,...  ...inclusive of sick time and school breaks (spring, winter, and summer) + additional sustainability half days throughout the school year... 

Expeditors

Entry-Level Logistics Specialist Job at Expeditors

 ...information business -Peter Rose, Expeditors Founder Global supply chain management is what we do, but at the heart of Expeditors you will find...  ...foster an innovative, customer service-based approach to logistics. ~18,000 trained professionals ~250+ locations... 

City of Panama City Florida

Assistant Superintendent-Underground Utilities Job at City of Panama City Florida

 ...requirements listed below are representative of the knowledge, skill and ability required. Reasonable accommodations may be made to enable Assistant Superintendent, Utilities, Underground, Equipment Maintenance, Superintendent, Wastewater City of Panama City Florida

Baylor Scott & White Health

Physician Assistant- Cardiology Job at Baylor Scott & White Health

 ...by the supervising physician. These providers work in a specialty clinic, and may specialize in Palliative Care, Pulmonary, Infectious Disease, Endocrinology, Gastroenterology, Cardiology, Dermatology, Urology, Nephrology, Neurology, Hematology, Oncology, Allergy and...