Job Details

Job DescriptionJob 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, of user / system requirements for protocol 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.