Validation Engineer – Las Piedras, PR

Job Description:

• Generating, executing, and reviewing protocols for Utilities, Manufacturing and Computer Systems.

• Analyze validation test data to determine whether systems or processes have met validation acceptance criteria or to identify root causes of production problems.

• Identify deviations from established product or process standards and provide recommendations for resolving deviations.

• Prepare, maintain, or review validation and compliance documentation, such as engineering change controls, schematics, or protocols.

• Conduct validation or qualification tests of new or existing processes, equipment, or software in accordance with internal protocols or external standards.

• Prepare detailed reports or design statements based on results of validation and qualification tests or reviews of procedures and protocols.

• Prepare validation or performance qualification protocols for new or modified manufacturing processes, systems, or equipment for pharmaceutical, electronics, or other types of production.

• Summarize Protocol execution and results for the IQ/OQ/PQ Summary Report.

• Coordinate Validation Projects and ensure project timelines.

• Generation of Process, Equipment and Computer Systems Periodic Reviews.

• Prepare Equipment Qualification, Utilities System Qualification and Continuous Process Validation (CPV) memos associated to Annual Product Reviews.

 

Basic Minimum Qualifications (BMQ):

• Must provide direction to team and external department related functions and activities

• Must have strong interpersonal skills

• Must have strong analytical skills

• Must be able to multitask and respond to shifting priorities

• Must be proficient with computer software (MS Office) and have expertise with spreadsheets

• Must have good communication skills, both written and verbal (English and Spanish)

• Must have prior mechanical and process equipment experience

• Must be results oriented

Education/ Experience (BMQ):

• A four-year, Bachelor of Science degree from an accredited college or university in an Engineering or Science discipline and 2-5 years of validation experience in a regulated industry or equivalent validation experience including ten years of food or pharmaceutical packaging or cGMP experience.

• Knowledge of packaging materials, process and packaging equipment is a must. • PC literacy including the ability to generate complex documents in both Microsoft Excel and Microsoft Word.