Validation Engineer I

Alcami Corporation • Pepperell, MA

16d • $32 - $38 • Onsite

About The Position

The Validation Engineer I performs validation equipment operation, protocol development and execution, and related activities. The role supports validation work involving laboratory and manufacturing equipment, technical support services, facilities and utilities, computerized systems, and data integrity assessment and remediation. Working under supervision, the engineer gains experience alongside more experienced staff. This is a 100% on-site position with travel to client sites, including up to 80% travel. The scheduled shift is Monday through Friday, 8:00 a.m. to 4:30 p.m.; occasional overnight or weekend off-shift coverage may be needed to accommodate schedules or project timelines.

The role requires regular work in offices, laboratories, and customer sites, with the physical activities and environmental exposures described in the posting. The base hourly pay range is $32.00–$38.00. Actual pay depends on factors including relevant skills, competencies, and experience, and may be reviewed periodically.

Requirements

• Bachelor of Arts or Bachelor of Science in a technical or science-related field; candidates with a high school diploma or GED, technical training, or an associate degree may qualify when combined with mechanical aptitude or relevant industry experience.
• Valid driver's license.
• Strong working knowledge of IT concepts, strategies, and methodologies.
• Proficiency with Microsoft Office, including Word, Excel, and PowerPoint.
• Strong written and verbal communication skills.
• Strong mechanical skills.
• Strong reporting, organizational, and interpersonal skills.
• Ability to multitask and perform tasks with high quality and accuracy.

Nice To Haves

• Validation experience or experience working in a GMP-regulated environment.
• Working knowledge of ISO 9001, ISO 17025, GMP, GLP, GAMP 5, and 21 CFR Part 11.

Responsibilities

• Perform pre- and post-validation verification on test equipment.
• Create and execute validation protocols and procedures, prepare final reports, and perform validation projects.
• Peer review validation reports.
• Learn and execute troubleshooting strategies in the field.
• Complete technical writing and documentation for validation reports.
• Write deviations and work with clients to resolve them.
• Maintain pertinent project records, including project cost reconciliation.
• Relay opinions or interpretations of results to customers.
• Perform other duties as assigned.

What This Job Offers

• Job Type: Full-time
• Career Level: Entry Level