Validation Engineer I

Alcami Corporation • Pepperell, MA

2d • $32 - $38 • Onsite

About The Position

At Alcami, the Validation Engineer I supports validation equipment operation, protocol development and execution, and related activities. The role covers validation work involving laboratory and manufacturing equipment, technical support services, facilities and utilities, computerized systems, and data integrity assessment and remediation. The engineer works under supervision to gain experience alongside more experienced staff.

This is a 100% on-site position with significant travel, including travel during the day to client sites and possible overnight travel. The regular schedule is first shift, Monday through Friday, 8:00 a.m. to 4:30 p.m. Occasional off-shift, overnight, or weekend coverage may be needed to accommodate schedules or project timelines. Up to 80% travel is expected.

The base hourly pay range is $32.00–$38.00. Actual pay depends on factors including relevant skills, competencies, and experience.

Requirements

• Bachelor’s degree in a technical or science-related field, or a high school diploma/GED or associate degree combined with technical training, 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.
• Perform peer reviews of validation reports.
• Learn and execute troubleshooting strategies in the field.
• Write and document validation reports.
• Write deviations and work with clients to resolve them.
• Maintain pertinent project records, including reconciliation of project costs.
• 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