Validation & Engineering Group

Life sciences validation and compliance consulting

Validation Engineer/Specialist

Validation, Compliance & Quality SystemsConfirmed live in the last 24 hours

Full-timeDuluth, GA, USANo salary listed

About the Job

Requirements

Expertise in a risk-based approach for commissioning and qualification practices.
Experience planning and integrating commissioning and qualification activities in medical device manufacturing; Class II experience is preferred.
Knowledge of risk management practices, including assessments, functional risk documents, and process failure mode and effects analysis.
Experience with equipment qualification and process validation.
Experience with computerized system validation, including programmable logic controllers and human-machine interfaces.
Knowledge of 21 CFR Part 11 requirements and how to incorporate them into an efficient testing strategy.
Three to five years of hands-on validation experience, including writing and executing validation protocols.
Ability to work independently with minimal supervision and communicate with project team members to ensure timelines are met.
Proficiency in Microsoft Office applications, including Word, Excel, and Project.
Effective interpersonal and problem-solving skills.
Demonstrated excellence in good documentation practices and attention to detail.

Responsibilities

Assist in deviation investigation and resolution for problems and issues encountered during field execution activities.

Desired Qualifications

Experience in Class II medical device manufacturing.

Job Description

Expertise in “Risk Based Approach” for Commissioning and Qualification practices
Planning and Integration of Commissioning and Qualification activities in medical device manufacturing (Class II preferred)
Risk Management practices (i.e. Assessments, Functional Risk Documents, pFMEA, etc.)
Equipment qualification and process validation
Computerized System Validation (PLC, HMI, etc.)
21 CFR Part 11 requirements and how to incorporate these requirements into an efficient testing strategy
Assist in deviation investigation and resolution for problems and issues encountered during field execution activities

Qualifications

Education:

B.S. Engineering (e.g. Computer Science, Chemical, Mechanical, Electrical, etc.)

Minimum Skills:

3-5 years hands-on validation experience (writing and execution of validation protocols)
Capable of working independently with minimal supervision, and communicating with project team members to assure timelines are met
Great technical writing and communication skills
Proficiency in Microsoft Office application (Word, Excel and Project)
Effective interpersonal and problem solving skills
Demonstrate excellence in good documentation requirements and attention to detail

Additional Information

Positions available for Puerto Rico.

Validation and Engineering Group, Inc is an Equal Employment Opportunity employer.

About the Company

Validation & Engineering Group

Life sciences validation and compliance consulting

Validation & Engineering Group provides regulatory compliance and engineering consulting for life sciences clients in Puerto Rico and the USA, serving pharma, biotechnology, medical devices, and food sectors. It guides the full product lifecycle, performing commissioning and qualification, computer system, equipment, process, and cleaning validation, drafting quality systems, and ensuring regulatory compliance with FDA and European standards. The firm differentiates itself with hands-on engineering expertise combined with deep regulatory knowledge and broad geographic reach, now enhanced after joining Pinnaql Inc. through an acquisition by 3Boomerang Capital, with founders continuing as partners for continuity. Its goal is to help clients bring products to market faster and more reliably by sustaining GMP-compliant operations and ongoing lifecycle compliance.

Company size: 51-200
Company stage: Not listed
Total funding: Not listed
Headquarters: Guaynabo, Puerto Rico
Founded: 1997

Recently Posted Jobs

Explore more opportunities at Validation & Engineering Group

See more jobs