What are the responsibilities and job description for the Validation Consultant position at UNITY Systems?
Job Title: Validation Engineer – Packaging and Systems
Location: Richmond, VA
Job Description:
We are seeking a highly skilled and motivated Validation Engineer to join our team. In this role, you will be responsible for developing and executing comprehensive validation plans for a variety of systems, including packaging lines, labelers, case packers, and low-speed pen assembly. The ideal candidate will have expertise in validating systems such as SEA Vision Yudoo and AVI, with a focus on ensuring compliance with industry standards and regulatory requirements.
As a Validation Engineer, you will work closely with cross-functional teams to drive successful validation activities, analyze test data, troubleshoot system issues, and maintain compliance with GMP and other applicable regulatory guidelines. You will be a key player in ensuring the quality and reliability of critical systems within our operations.
Key Responsibilities:
- Develop and implement comprehensive validation plans for packaging lines, labelers, case packers, and low-speed pen assembly systems.
- Lead the validation of various systems, including SEA Vision Yudoo and AVI systems, ensuring adherence to industry standards and regulatory requirements.
- Prepare, execute, and document Installation Qualification (IQ), Operational Qualification (OQ), Performance Qualification (PQ), and Validation Summary Reports (VSR).
- Collaborate with cross-functional teams, including operations, engineering, and quality, to ensure smooth execution of validation activities and resolution of any challenges encountered.
- Analyze test data, identify trends, and recommend system improvements or changes when necessary.
- Ensure that all validation activities comply with Good Manufacturing Practices (GMP) and other applicable regulatory requirements.
- Provide support during internal and external audits related to validation activities.
- Stay up-to-date with the latest industry standards, trends, and validation techniques to ensure best practices are followed.
Required Qualifications:
- Bachelor’s degree in Engineering, Life Sciences, or a related field (or equivalent experience).
- Proven experience working in aseptic environments within the biotechnology or pharmaceutical industry.
- Minimum of 5 years of experience in validating packaging lines, labelers, case packers, and low-speed pen assembly systems.
- Strong expertise in SEA Vision Yudoo and AVI systems validation.
- Familiarity with regulatory guidelines such as FDA, ISO, and GMP.
- Experience in developing validation plans, and documentation (IQ, OQ, PQ, VSR).
- Excellent troubleshooting, analytical, and problem-solving skills.
- Strong written and verbal communication skills.
- Ability to work independently as well as part of a collaborative team.
Preferred Qualifications:
- Certification in validation or related fields.
- Experience with continuous improvement initiatives or lean manufacturing practices.
- Knowledge of additional validation systems or technologies relevant to packaging and assembly processes.
Job Types: Full-time, Contract
Pay: $70.00 - $80.00 per hour
Expected hours: 40 per week
Benefits:
- 401(k)
- 401(k) matching
- Dental insurance
- Health insurance
- Life insurance
- Paid time off
- Vision insurance
Schedule:
- 10 hour shift
- 8 hour shift
- Day shift
- Monday to Friday
- Weekends as needed
Work Location: On the road
Salary : $70 - $80
