Validation Engineer
JLL - Las Piedras, PR
Position Summary:
ESSENTIAL FUNCTIONS
- 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.
KNOWLEDGE, SKILLS, AND ABILITIES
- Able to provide direction to team and external department related functions and activities
- Strong interpersonal skills
- Strong analytical skills
- Able to multitask and respond to shifting priorities
- Proficient with computer software (MS Office) and have expertise with spreadsheets
- Good communication skills, both written and verbal (English and Spanish)
- Results oriented
EDUCATION AND EXPERIENCE
- BS/BA degree from an accredited college or university in an Engineering or Science discipline
- Minimum 2 years of validation experience in a regulated industry or equivalent validation experience, including ten years of food or pharmaceutical manufacturing or cGMP experience.
- Knowledge of pharmaceutical solid dosage manufacturing equipment, critical utilities, and computer systems, a must
- Prior mechanical and process equipment experience
Start a lasting career with JLL today!
Total Rewards reflects JLL’s investment in employees’ needs and preferences in Career, Recognition, Well-being, Benefits and Pay. We offer a competitive salary and benefits package. To be considered, please visit our Web site at www.us.am.joneslanglasalle.com/UnitedStates/EN-US/Pages/Careers.aspx to apply online. All resumes MUST BE submitted via our web site. Please reference Job 52786BR
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Posted: 30+ days ago
