Pharma Validation Engineer II – Equipment & PLC Systems

Fagron Nederland BV; Canton (MA); On-site; USD 105,000 - 145,000; Full time

Benefits offered by this job

401(k) plan with company match

Medical insurance

Vision and dental coverage

Health Savings Account (HSA)

Paid time off

Job summary

Fagron US seeks a qualified validation engineer to validate pharmaceutical manufacturing equipment and control systems, perform instrument calibration, and document validation activities including media fills and stability studies. You will work with the Kaye AVS Validator, read PI&Ds and drawings, and ensure compliance with 21 CFR Part 11 and cGMP guidelines in a fast-paced manufacturing environment.

Fagron US offers competitive salaries and a comprehensive benefits package, fostering an

Qualifications

• BS degree in mechanical, industrial, automation or chemical engineering, or equivalent pharma experience.
• 3–5 years in metrology and validation of pharma manufacturing equipment.
• Experience with regulatory inspections and defending work.
• Knowledge of GMP/cGMP, FDA/EMA/ICH guidelines and data integrity.
• Familiarity with 21 CFR Part 11 and related data governance.

Responsibilities

• Prepare, execute and summarize validation protocols and reports.
• Read and interpret PI&Ds, electrical and pneumatic drawings.
• Work with PC and PLC-based control systems software and hardware.
• Validate utilities, distillate systems, filling machines, autoclaves, stability chambers.
• Perform PV and stability studies and document findings.
• Ensure compliance with FDA and cGMP guidelines.

Skills

Metrology

Validation

Regulatory inspections

cGMP knowledge

Data Integrity

21 CFR Part 11 knowledge

Education

BS in Mechanical/Industrial/Automation/Chemical Engineering

Tools

Kaye AVS Validator

Job description

Fagron US seeks a qualified validation engineer to validate pharmaceutical manufacturing equipment and control systems, perform instrument calibration, and document validation activities including media fills and stability studies. You will work with the Kaye AVS Validator, read PI&Ds and drawings, and ensure compliance with 21 CFR Part 11 and cGMP guidelines in a fast-paced manufacturing environment.

Fagron US offers competitive salaries and a comprehensive benefits package, fostering an