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

The Senior Validation Engineer will plan, schedule, coordinate, and track all facets of assigned validation projects. Develop highly specific protocols and execute complex systems. The Sr. Validation Engineer will execute protocols for Installation, Operational and Performance Qualification testing on chambers and rooms including: cryo-freezers, cold rooms, refrigerators, incubators, sterilizers, depyrogenation ovens, stability chambers, and warehouses. Also, Steam in Place (SIP) validation using biological indicators and projects requiring specialized knowledge or expertise (GMP manufacturing facilities and equipment, computerized systems). Process, assemble and review data, generate documentation and reports. The Sr. Validation Engineer will be a source of technical knowledge for validation staff and customers and will deliver excellent customer service, resulting in long-term relationships.

On-Site Expectations

• 100% on-site position at client sites. Prefer candidates who reside in the North Chicago, IL (Midwest) region.
• 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.
• Train validation team members.
• Other duties as assigned.

Qualifications

• BA/BS in technical or science related field of study preferred. Candidates with an HSD/GED, technical training, or an Associate's degree combined with mechanical aptitude or relevant industry experience considered.
• 5+ years of direct validation experience required.

Knowledge, Skills, and Abilities

• Technical expertise with CTUs and autoclaves.
• Experience with CQV for equipment qualifications.
• Experience with validation of temperature-controlled units and temperature mapping.
• Experience with validation of sterilization processes (steam sterilizers, SIP).
• Experience with validation of GMP laboratory and manufacturing equipment and computerized systems.
• Calibration expertise (temperature, humidity, CO2, pressure, timer) is a plus.
• 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, the employee will frequently work in an office, lab or at customer sites and be exposed to extreme cold (non-weather). The employee 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.