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Senior Validation Engineer – Midwest
Alcami Corporation. Perform pre- and post-validation verification on test equipment .
About the role
Key responsibilities & impact- 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
- Train validation team members
- Other duties as assigned.
Requirements
What you’ll need- BA/BS in technical or science related field of study preferred
- Candidates with an HSD/GED, technical training, or an Associate’s degree combined with mechanical aptitude or relevant industry experience considered
- 5+ years of direct validation experience required
- Technical expertise with CTUs and autoclaves
- Experience with CQV for equipment qualifications
- Experience with validation of temperature-controlled units and temperature mapping
- Experience with validation of sterilization processes (steam sterilizers, SIP)
- Experience with validation of GMP laboratory and manufacturing equipment and computerized systems
- Calibration expertise (temperature, humidity, CO2, pressure, timer) is a plus
- Ability to perform tasks with high standard of quality and accuracy
- Spreadsheet and word processing applications experience, computer literacy
- Strong written and verbal communication skills
- Proficient with test instruments
- ISO 9001, ISO 17025, GMP and GLP knowledge.
Benefits
Comp & perks- medical, dental, vision and prescription coverage
- life insurance
- long term disability (LTD)
- short term disability (STD)
- 401(k) with match and immediate vesting
- tuition reimbursement / student loan forgiveness
ATS Keywords
✓ Tailor your resumeApplicant Tracking System Keywords
Tip: use these terms in your resume and cover letter to boost ATS matches.
Hard Skills & Tools
validation experiencecalibrationtemperature mappingsterilization processesGMP laboratory equipmentcomputerized systems validationtechnical writingtroubleshooting strategiesCQV for equipment qualificationstest instruments
Soft Skills
strong written communicationstrong verbal communicationability to manage documentationpeer reviewtraining team membershigh standard of qualityaccuracyclient resolutionproject cost reconciliationopinion relay
Certifications
ISO 9001ISO 17025GMPGLP