Lead Validation Engineer
- Job Title
- Lead Validation Engineer
- Job ID
- 27756304
- Location
- Oklahoma City, OK, 73102
- Other Location
- Description
-
Position Overview: Reporting to the Director of Manufacturing Science and Technology, the Lead Validation Engineer has a primary focus on the daily execution and compliance of Wheeler validation program. The validation activities include, but are not limited to Equipment Qualification / Validation, Temperature mapping / monitoring activities, Computer Software Evaluation and Validation, generation of user / system requirements for protocol generation and SOP writing, etc. This role requires a meticulous attention to detail, strong leadership capabilities, and a deep understanding of equipment and software validation and associated industry guidance.
Key Responsibilities:
· Evaluate new equipment and/or software with internal stakeholders to develop and implement user requirements for qualification and/or validation.
· Draft and execute qualification (Installation, Operation and Performance) and validation protocols for equipment and software.
· Conduct equipment and facility mapping and monitoring needs within controlled environments.
· Oversee and facilitate Wheeler’s validation master plan, and support client’s needs for equipment and process validation.
· Support Wheeler’s equipment cleaning needs, verification and validation, as applicable.
· Support and/or lead investigations into quality issues, identify root causes, and implement corrective and preventive actions (CAPAs).
· Manage calibration and validation equipment, to ensure readily available for current and future projects.
· Write SOPs, Company Policies and collaborate with internal team.
· Assist with audits and inspections as needed, from clients and/or Regulatory Representatives.
· Other duties as assigned.
Qualifications:
· Bachelor's degree in a relevant scientific field or equivalent experience.
· Minimum of 5 years of experience in Engineering, Validation and/or other, as applicable in the biotechnology or pharmaceutical industry.
· Familiarity with cGMP and other relevant quality standards and regulatory requirements.
· Knowledge in Manufacturing Process Validation, Continuous Verification is a bonus.
· Excellent communication and organizational skills.
