Lead Validation Engineer

ZipRecruiter; Oklahoma City (OK); On-site; USD 80,000 - 120,000; Full time

Job summary

A leading company is seeking a Lead Validation Engineer to ensure compliance with validation standards for equipment and processes in manufacturing. This role involves direct oversight of validation protocols, equipment evaluations, and audits, working closely with internal teams to maintain quality assurance in the biotech industry.

Qualifications

• Minimum of 5 years of experience in Engineering, Validation, or relevant fields.
• Familiarity with cGMP and relevant quality standards required.
• Knowledge of Manufacturing Process Validation and Continuous Verification is a bonus.

Responsibilities

• Evaluate new equipment and/or software for qualification and validation.
• Draft and execute qualification and validation protocols.
• Manage calibration and validation equipment.

Skills

Attention to detail

Leadership capabilities

Excellent communication

Organizational skills

Education

Bachelor's degree in a relevant scientific field

Job description

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.