Validation & Engineering Group

Life sciences validation and compliance consulting

Validation Engineer/ Specialist

Regulatory & Quality (Life Sciences)Confirmed live in the last 24 hours

Full-timeJohns Creek, GA, USANo salary listed

About the Job

Requirements

A bachelor's degree in Engineering or Science is required.
Five to ten years of experience in the medical device, biotechnology, or pharmaceutical industry is required.
Experience validating autoclaves is required.
Experience with the Validation Life Cycle, including process, packaging, and cleaning, is required.
Knowledge of regulations, including Good Manufacturing Practices, is required.
Experience developing and conducting efficient processes to meet production demands is required.
Strong technical writing and verbal communication skills are required.
Ability to identify milestones and maintain attention to detail is required.
Ability to interact with all areas of the organization and with clients is required.
Proficiency with Microsoft Office, including Word, Excel, and PowerPoint, is required.
Availability to work extended hours and holidays when required is required.
Availability to travel and work non-standard shifts when necessary is required.

Responsibilities

Conduct validation activities for the assigned project, including validation of multiple autoclaves and temperature controllers.
Perform validation scope activities, which may include the Validation Life Cycle, execution, technical documentation, process validation, gap analysis, risk assessment, and commissioning and qualification activities.

Desired Qualifications

Experience in liquid dosage is a plus.
Bilingual Spanish and English language ability is a plus but is not required.

Job Description

The Validation Engineer/ Specialist will be responsible of all validation activities for the assigned project. This project include the validation of multiple autoclaves and Temperature controllers. Validation Scope may include: Validation Life Cycle, Execution, Technical Documentation, Process, GAP Analysis, Risk Assessment, C&Q activities, among others.

Qualifications

Bachelor degree in Engineering or Science
5 to 10 years of experience required in the medical device, biotechnology or pharmaceutical industry (liquid dosage a PLUS).
MUST have experience validating autoclaves
Experience with Validation Life Cycle (Process, Packaging and Cleaning).
Experience and knowledge in regulations, including GMP.
Experience developing and conducting efficient processes to meet production demands.
Excellent technical writing and verbal communication skills are required.
Excellent detail oriented individual who can identify milestones.
Great interpersonal and communications skills.
Able to interact with all areas and clients.
Proficiency utilizing MS Office Suite (Word, Excel and PowerPoint) is required.
Available to work extended hours, holidays if require.
Must be available to travel and work non-standard shifts if necessary.
Only candidates who qualifies with all requirements will be evaluate.
Bilingual (Spanish & English) a plus but not necessary.

Additional Information

Validation and Engineering Group, USA 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

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