Analytical Equipment Qualification Specialist (GMP/21 CFR)

Posted today

techdigital groupSkaneateles Falls (NY)

Quality Control Analysts Electronic and Precision Equipment Repair and Maintenance

SENIORITY

Lead

Apply

About the role

TechDigital Group is seeking a qualified professional to serve as the technical SME for qualification of analytical equipment in its manufacturing environment. You will author and execute URS, DQ, IQ, OQ, and PQ protocols according to GAMP 5, FDA 21 CFR Part 11, and EU Annex 11. You will lead lifecycle activities, ensure data integrity, and support audits with expert SME-level responses. The role requires collaboration with Quality, Validation, Metrology, IT, and Lab teams to define

Before you apply

Applying takes about a minute. These four things decide how fast it moves after that.

Your profile is current

It's what we read first. Occupations, seniority and locations matter more than a long history.

Two examples you can talk through

Not a portfolio — just two pieces of work where you can explain the decisions and what you'd change.

A number in mind

What you're on now and what would make you move. We negotiate better when we know both.

Your notice period

Employers plan around it, and it's the question that stalls offers most often.

Once you apply, someone reads it and calls you before anything reaches the employer — usually within two working days.