Senior Quality Assurance and Validation Engineer
Senior Quality Assurance and Validation Engineer
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Job Description
Were looking for a Senior Quality Assurance and Validation Engineer who thrives on precision and continuous improvement. If youre passionate about raising the bar and driving quality at every stage your next challenge starts here.
Who is Meissner
The goal at Meissner is to be more than simply good; it is to be extraordinary. Extraordinary performance comes from extraordinary people.
Meissner as a group is passionate about helping our clients manufacture lifesaving and life enhancing drugs therapies and vaccines. We develop manufacture supply and service advanced microfiltration products and single-use systems worldwide.
We know that when you are passionate about what you do its more than just a job.
Meissner is focused on the development of the whole individual and we have programs and tools in place to help us stay at our best mentally and physically. In alignment with our commitment to support the growth and development of the whole individual Meissner has inaugurated a Learning and Development department to solely focus on cultivating our team. When you grow we grow.
How you will make an impact:
We are seeking a proactive and detail-driven Quality Assurance and Validation Engineer to play a critical role in maintaining quality systems compliance ensuring product and process compliance with internal quality standards and external regulatory requirements as well as the ongoing support of irradiation operations. This role combines core quality engineering functions with specialized responsibilities in equipment/process validation system qualification and internal and supplier auditing. The ideal candidate will be well versed in quality management systems risk management and regulatory frameworks such cGMP.
- Ensure quality system compliance across product receipt handling processing and distribution processes.
- Support product lifecycle activities through quality engineering best practices.
- Develop and maintain Validation Master Plans (VMP).
- Author review and execute Installation Qualification (IQ) Operational Qualification (OQ) and Process Performance Qualification (PPQ) protocols for equipment systems products and processes.
- Lead customer audits and regulatory inspections related to irradiation operations.
- Follow up on audit findings to ensure timely and effective corrective actions.
This is an on-site role based in Athens GA.
The skills and experience youll need:
- Bachelors degree in a technical or scientific field (e.g. Engineering Life Sciences Quality Management) required.
- 7 years of experience in Quality Assurance within a regulated industry (e.g. medical devices pharma biotech manufacturing).
- Direct experience in process development and/or validation for at least one of the common irradiation method (gamma xray or ebeam).
- Awareness of applicable sterilization standards specifically ISO 11137.
- Familiarity with sterilization processes and applicable standards including cycle design validation dosimetric aspects and process control.
- Experience with validation/qualification protocols and audit programs.
Dont meet every single requirement Apply anyway.
What we can offer you:
- Full Medical Dental and Vision coverage with HSA Employer Contributions for eligible plans
- Additional Perks- HQ Onsite Full Gym Ultramodern Coffee Bars Free EV Charging Stations Employee Discounts
- 401k Profit Sharing 401k Advisory Services
- Employee Assistance Program
- Paid Time Off Paid Holidays Anniversary Holiday
Ready to make an impact Lets talk.
Meissner is proud to be an Equal Opportunity Employer.
US BASE PAY SCALE $94400 - $133300
The base pay scale for this role is what Meissner reasonably expects to pay for the position although actual pay may vary from this scale depending on an applicants experience.
Required Experience:
Senior IC
Employment Type
Full Time
