Validation Engineer I

Validation Engineer I Location

US-MA-Pepperell ID

2026-2308

Category Validation

Position Type Full-Time

Working Hours 1st Shift: Monday - Friday, 8:00am - 4:30pm

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. This position will require significant travel. 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. Overnight travel may be required depending on project requirements.

Physical Demands and Work Environment

The physical demands and work environment described here are... For full info follow application link.