Validation Engineer at Jobot
Ansonia, CT 06401
About the Job
Validation Engineer - (Responsive)
This Jobot Job is hosted by: David Six
Are you a fit? Easy Apply now by clicking the "Quick Apply" button
and sending us your resume.
Salary: $80,000 - $90,000 per year
A bit about us:
Are you a dynamic, detail-oriented engineer with a passion for problem-solving and a desire to make a significant impact in the manufacturing industry? We are seeking a Permanent Validation Engineer to join our client's team. You will be responsible for validating and qualifying systems, equipment, and processes in accordance with regulatory requirements, industry standards, and our company’s quality standards. This role is an integral part of our manufacturing operations, ensuring that our processes are efficient, effective, and consistently meet our high quality and safety standards.
Why join us?
Job Details
Responsibilities:
As a Validation Engineer, you will:
1. Develop and execute validation protocols for equipment, systems, and processes, including Installation Qualification (IQ), Operational Qualification (OQ), and Performance Qualification (PQ).
2. Conduct risk assessments and process failure mode effects analysis (PFMEA) to identify and mitigate risks in the validation process.
3. Review and approve validation and compliance documentation, including SOPs, validation master plans, process flow diagrams, test cases, and deviation reports.
4. Collaborate with cross-functional teams, including Quality Assurance, Production, and Engineering, to implement process improvements and address validation issues.
5. Ensure compliance with all relevant regulatory standards and guidelines, including FDA, ISO, and GMP.
6. Conduct routine re-validation or re-qualification to ensure continued compliance with internal and external quality standards.
7. Provide technical guidance and training to junior validation engineers and other team members.
8. Participate in internal and external audits.
Qualifications:
The ideal candidate for this position will possess the following:
1. Bachelor's degree in Engineering, or a related technical field.
2. A minimum of 5 years of experience in validation engineering in the manufacturing industry, with a strong understanding of validation principles, technologies, and regulatory requirements.
3. Proficiency in Process Failure Mode Effects Analysis (PFMEA) is a must.
4. Strong technical writing skills, with the ability to produce clear, concise, and accurate validation documents.
5. Excellent problem-solving skills, with a strong attention to detail and a commitment to quality.
6. Strong interpersonal and communication skills, with the ability to work effectively in a team environment and communicate complex technical information to non-technical stakeholders.
7. Proficiency in Microsoft Office Suite, including Word, Excel, and PowerPoint.
8. Experience with statistical analysis software, such as Minitab, is a plus.
9. Certified Validation Professional (CVP) or similar certification is preferred.
If you are a driven, results-oriented engineer with a passion for quality and a desire to make a difference, we would love to hear from you. Apply today and take the next step in your career as a Validation Engineer!
Interested in hearing more? Easy Apply now by clicking the "Quick Apply" button.
This Jobot Job is hosted by: David Six
Are you a fit? Easy Apply now by clicking the "Quick Apply" button
and sending us your resume.
Salary: $80,000 - $90,000 per year
A bit about us:
Are you a dynamic, detail-oriented engineer with a passion for problem-solving and a desire to make a significant impact in the manufacturing industry? We are seeking a Permanent Validation Engineer to join our client's team. You will be responsible for validating and qualifying systems, equipment, and processes in accordance with regulatory requirements, industry standards, and our company’s quality standards. This role is an integral part of our manufacturing operations, ensuring that our processes are efficient, effective, and consistently meet our high quality and safety standards.
Why join us?
- Amazing benefits
- Professional growth
- Work with products from diverse industries
- Supportive, friendly, and dynamic team environment
- Competitive compensation and benefits package
Job Details
Responsibilities:
As a Validation Engineer, you will:
1. Develop and execute validation protocols for equipment, systems, and processes, including Installation Qualification (IQ), Operational Qualification (OQ), and Performance Qualification (PQ).
2. Conduct risk assessments and process failure mode effects analysis (PFMEA) to identify and mitigate risks in the validation process.
3. Review and approve validation and compliance documentation, including SOPs, validation master plans, process flow diagrams, test cases, and deviation reports.
4. Collaborate with cross-functional teams, including Quality Assurance, Production, and Engineering, to implement process improvements and address validation issues.
5. Ensure compliance with all relevant regulatory standards and guidelines, including FDA, ISO, and GMP.
6. Conduct routine re-validation or re-qualification to ensure continued compliance with internal and external quality standards.
7. Provide technical guidance and training to junior validation engineers and other team members.
8. Participate in internal and external audits.
Qualifications:
The ideal candidate for this position will possess the following:
1. Bachelor's degree in Engineering, or a related technical field.
2. A minimum of 5 years of experience in validation engineering in the manufacturing industry, with a strong understanding of validation principles, technologies, and regulatory requirements.
3. Proficiency in Process Failure Mode Effects Analysis (PFMEA) is a must.
4. Strong technical writing skills, with the ability to produce clear, concise, and accurate validation documents.
5. Excellent problem-solving skills, with a strong attention to detail and a commitment to quality.
6. Strong interpersonal and communication skills, with the ability to work effectively in a team environment and communicate complex technical information to non-technical stakeholders.
7. Proficiency in Microsoft Office Suite, including Word, Excel, and PowerPoint.
8. Experience with statistical analysis software, such as Minitab, is a plus.
9. Certified Validation Professional (CVP) or similar certification is preferred.
If you are a driven, results-oriented engineer with a passion for quality and a desire to make a difference, we would love to hear from you. Apply today and take the next step in your career as a Validation Engineer!
Interested in hearing more? Easy Apply now by clicking the "Quick Apply" button.
Salary
80,000 - 90,000 /year