Sr. Computer system Validation Engineer job at Planet Group Saint Joseph, MO, US

Job Description

Validation documentation Authoring (validation plans, user requirements specifications, risk assessment, IQ-OQ-PQ protocols, trace matrix and summary reports)
Experience in validating GMP Lab systems and Equipment
Responsible for assuring a system/application meets its requirements as outlined in system specification (URS/FRS) per process defined in the Validation Plan for the project.
Identify and escalate, as necessary project risks and issues to the CSVC Manager.
Engage in multiple CSVC projects through the assimilation of data, establishing facts and drawing valid conclusions to deliver results in accordance with resources, constraints and business needs.
Be able to prepare reports on defects and problems that arise during system testing.
Have solid oral and written communication skills and teamwork skills.
Be a good team player, able to meet deadlines and handle changing priorities.
Have strong judgment capabilities to clarify requirements when necessary.
Have the ability to work with cross functional teams
Have solid experience working with validated systems.
Work with business representatives to ensure the test cases reflect business rules and processes.
Fulfills a subject matter expert role(s) for critical quality and compliance GxP end-use applications supporting Animal Health business processes.

Skills:
Required Experience

GMP/Regulated lab, more than 5 years of CSV experience required.
Technical writing Experience
Highly skilled in Computerized System testing and validation in the healthcare industry.
Knowledge of GxP regulations (e.g. 21 CFR Part 11, Annex 11)
Solid project organizational skills. Ability to multi-task.
Must have strong analytical problem-solving skills.
Excellent communication including written, verbal, and listening skills.
Self-motivated, detail oriented, takes initiative and ability to work independently without close supervision.

Education:

BS in Science or Technical Writing Degree

Pay Rate Range: $65-80/hr depending on experience

Job Tags

Contract work,

Similar Jobs

Randstad Digital Americas

Cyber Security Engineer Job at Randstad Digital Americas

...CLEARANCE REQUIRED Job Description The position requires security engineering skills with a working knowledge of Information Assurance... ...generating requirements, architecture design, configuring Cyber audit tools, conducting verification, and performing Cyber vulnerability...

HW Management, Inc.

Hotel Housekeeper Job at HW Management, Inc.

REPORTS TO: Executive Housekeeper FLSA STATUS: Non-Exempt, HourlyPOSITION SUMMARYPerform cleaning duties to maintain hotel rooms in a clean and orderly manner. RESPONSIBILITIESThe Room Attendant is responsible for completion of the following tasks:* Carry...

Ingenium Talent

Piping Designer Job at Ingenium Talent

...organization that is a market leader in its industry and is well known for its ingenuity. About the Role - They are looking for a piping designer with structural experience that will work as part of a cohesive team focusing on the design of pressure piping, 3D modeling,...

Aspen Contracting LLC

Construction Sales Job at Aspen Contracting LLC

...detailed inspection reports and scope of work documents. Act as a liaison between... ...specifications. Qualifications and Experience: ~ High school diploma or equivalent required... .... No prior experience in insurance or construction? No problem! We're seeking individuals...

Wegmans Food Markets

Certified Pharmacy Technician Job at Wegmans Food Markets

Schedule: Part time Availability: Morning, Afternoon, Evening (Includes Weekends). Age Requirement: Must be 18 years or older Location: Charlottesville, VA Address: 100 Wegmans Way Pay: $21 - $21.50 / hour Job Posting: 01/17/2025 Job Posting End:...