Validation Engineer II

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

About the Job

The successful candidate will have experience validating manufacturing equipment and PLC and Computer-Based control systems. Perform and document instrument calibration and validation activities on a variety of pharmaceutical manufacturing equipment and troubleshooting and repair and, process validation i.e., media fills and stability studies.

Key Responsibilities

• Prepare, execute and summarize validation protocols and reports.
• Proficiency with the Kaye AVS Validator (Programming, Operating, Setup etc.
• Able to read and understand equipment PI&Ds, Electrical, Pneumatic and arrangement drawings.
• Working knowledge of PC and PLC base control systems software and hardware.
• Working knowledge of FDA and cGMP guidelines as related to CVQ.
• Experience validating and qualifying, but not limited to Utilities, Distillate Systems, Syringe, Vial and Eye Dropper Filling Machines, Autoclaves, Glassware and Vial Washers, Stability Chambers Drug Product Storage and Cleanrooms.
• Experience with PV and Stability studies.
• Has the functional and technical knowledge and skills to do the job at a high level of accomplishment.
• Uses rigorous and logic and methods to solve difficult problems with effective solutions.
• Maintains a conscious balance between work and personal life as to not allow one to dominate the other.

Basic Qualifications

• BS degree in Mechanical, Industrial, Automation, or Chemical Engineering. and/or equivalent experience in pharmaceutical related discipline.
• 3 to 5 years experiences in metrology and validation of pharmaceutical manufacturing equipment.
• Experience participating in regulatory inspections and explaining/defending work.
• General knowledge of the injectable pharmaceutical industry, sterile compounding preferred.
• Experience working in cGMP environments meeting FDA, EMA, ICH guidelines, local regulations, and industry best practices.
• Working knowledge of applicable GMP regulations, particularly 21 CFR Part 11, Eudralex Volume 4 Annex 11, and current FDA/MHRA guidance on Data Integrity.
• Experience with aspects of pharmaceutical GMP regulations (e.g. quality systems, root cause analysis).
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What's on Offer?

Fagron offers its associates competitive salaries and a wide range of benefits including a 401(k) plan with a company matching contribution; medical, vision and dental; health savings account (HSA); holiday/paid time off.

At Fagron, you’ll find plenty of chances to grow — both personally and professionally. We work in an open, dynamic environment where your ideas and talents can shine.

Ready for the challenge?

We’re proud to be an equal opportunity employer. Diversity makes us stronger, and we’re committed to creating an inclusive workplace where everyone feels welcome.

Fagron US is committed to creating a diverse environment and is proud to be an equal opportunity employer. All qualified applicants will receive consideration for employment without regard to race; creed; color; religion; national origin; sex; age; disability; sexual orientation; gender identity or expression; genetic predisposition or carrier status; veteran, marital, or citizenship status; or any other status protected by law.