Alcami

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 I involve validation equipment operation, protocol development, protocol execution and associated activities. This position will support a wide range of validation activities, including laboratory and manufacturing equipment of all types, laboratory and manufacturing technical support services, facilities/utilities, computerized systems, and data integrity assessment/remediation. The Validation Engineer I works with supervision to gain experience with more experienced staff.

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 overnight and/or weekend coverage to accommodate schedules and/or project timelines.

Responsibilities

• Perform pre- and post-validation verification on test equipment.
• 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.
• 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.
• Valid driver’s license required.

Knowledge, Skills, and Abilities

• Strong working knowledge of IT concepts, strategies, and methodologies.
• Proficient with Microsoft Office (Word, Excel, PowerPoint).
• Strong written and verbal communication skills.
• Strong mechanical skills.
• Strong reporting, organizational, and interpersonal skills.
• Ability to multitask and to perform tasks with high quality and accuracy.
• Validation experience or experience working in a GMP regulated environment is a plus, including working knowledge of ISO 9001, ISO 17025, GMP, GLP, GAMP 5 and 21 CFR Part 11.

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.