Validation Engineer I

Alcami Corporation • Pepperell, MA

1d • $32 - $38 • Onsite

About The Position

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. 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.

Requirements

• BA/BS in technical or science related field of study. Candidates with a HSD/GED, technical training, or an Associate’s degree combined with mechanical aptitude or relevant industry experience.
• Valid driver’s license required.
• 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.

Nice To Haves

• 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.

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.

What This Job Offers

• Job Type: Full-time
• Career Level: Entry Level
• Education Level: High school or GED