Validation Engineer II - On-Site Field Specialist

Alcami; Pepperell (MA); On-site; USD 52,000 - 65,000; Full time

Job summary

Alcami is seeking a Validation Engineer II to lead validation activities for environmental chambers and related equipment at customer sites. You will prepare equipment, execute validation protocols, and generate final reports, coordinating with clients as needed.

This is an on-site role with up to 80% travel. The schedule is 1st shift, Monday–Friday, 8:00am–4:30pm, with occasional off-shift or weekend coverage to meet project timelines. Prior validation experience is required.

Qualifications

• BA/BS in technical or science field; other forms acceptable.
• Minimum of two years direct validation experience.
• Experience with validation of temperature-controlled units and temperature mapping.
• Strong written and verbal communication skills.
• Proficient with test instruments; spreadsheet and word processing experience.
• Knowledge of ISO 9001, ISO 17025, GMP and GLP.

Responsibilities

• Perform pre- and post-validation verification on test equipment.
• Perform calibrations incidental to validation including controllers, gauges, recorders, etc.
• 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.
• Independently manage 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.

Skills

Validation experience

Communication skills

Spreadsheet & word processing

Test instruments proficiency

ISO 9001/17025, GMP/GLP knowledge

Education

BA/BS in technical or science field

HSD/GED or Associate’s degree with related experience

Job description

Alcami is seeking a Validation Engineer II to lead validation activities for environmental chambers and related equipment at customer sites. You will prepare equipment, execute validation protocols, and generate final reports, coordinating with clients as needed.

This is an on-site role with up to 80% travel. The schedule is 1st shift, Monday–Friday, 8:00am–4:30pm, with occasional off-shift or weekend coverage to meet project timelines. Prior validation experience is required.