Validation Engineer II

At Alcami, we deliver reliable solutions that unlock the potential of transformative medicines from discovery to commercialization, through trusted partnership with our clients, recognized industry expertise and proven regulatory track record.

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Job Summary

Responsibilities for a Validation Engineer II involve validation equipment preparation, protocol execution, and final report generation. This position will perform a wide range of validation activities focused on environmental chambers, including: cryo-freezers, cold rooms, refrigerators, incubators, depyrogenation ovens, stability chambers and warehouses, as well as sterilizers and CSV. Interface with customers and equipment end users. The Validation Engineer II works with minimal supervision and will independently work at customer sites with small and medium projects.

On-Site Expectations

• 100% on-site position.
• 1st Shift: Monday - Friday, 8:00am - 4:30pm.
• This position is for day shift but may require some occasional off shift and/or weekend coverage to accommodate schedules and/or project timelines.

Responsibilities

• Perform pre- and post-validation verification on test equipment.
• Perform calibrations incidental to validation including controllers, gauges, recorders, etc.
• Create and execute validation protocols, procedures, and final reports; perform validation projects.
• Perform peer review of validation reports.
• Learn and execute troubleshooting strategies in the field.
• Independently manage technical writing and documentation aspects of validation reports.
• Write and work with clients to resolve deviations.
• Maintain records of pertinent information for the project including project costs reconciliation.
• Relay opinions or interpretations of results to customer.
• Other duties as assigned.

Qualifications

• BA/BS in technical or science related field of study. Candidates with an HSD/GED, technical training, or an Associate’s degree combined with mechanical aptitude or relevant industry experience.
• Minimum of two years of direct validation experience.

Knowledge, Skills, and Abilities

• Experience with validation of temperature-controlled units and temperature mapping.
• Ability to perform tasks with high standard of quality and accuracy.
• Spreadsheet and word processing applications experience, computer literacy.
• Strong written and verbal communication skills.
• Proficient with test instruments.
• ISO 9001, ISO 17025, GMP and GLP knowledge.

Travel Expectations

• Up to 80% travel expected. This position includes travel during the day to client sites.

Physical Demands and Work Environment

The physical demands and work environment described here are representative of those that must be met by an employee to successfully perform the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions. While performing the duties of this job, the employee will regularly stand, walk, and use hands, frequently reach, stoop, kneel, crouch or crawl and talk or hear, and occasionally sit and climb or balance. In this role, you will frequently work in an office, lab or at customer sites and be exposed to extreme cold (non-weather). You will occasionally be exposed to wet or humid conditions, work near moving mechanical parts, work in high places, near toxic or caustic chemicals, in outdoor weather conditions and exposure to vibration. The noise level that is typical for this position is loud.