Validation Engineer jobs in Indiana

Role Description:

We are seeking a Validation Lead to oversee and ensure compliance with Computer System Validation (CSV) standards and quality in a regulated environment for a new BU IDS project.

Responsibilities:

Lead validation activities in alignment with CSV and quality standards.

Ensure validation processes comply with regulatory requirements.

Manage validation documentation and ensure it meets compliance standards.

Collaborate with cross-functional teams to implement validation protocols.

Oversee the execution of validation test plans and protocols.

Identify and address validation issues, ensuring timely resolution.

Provide training and guidance on validation procedures and standards.

Maintain up-to-date knowledge of industry regulations and standards.

Prepare and present validation reports to senior management and stakeholders.

Essential Skills:

Extensive experience in Computer System Validation (CSV).

Strong understanding of quality standards in regulated environments.

Proven track record in leading validation projects.

Ability to manage validation documentation and ensure compliance.

Excellent problem-solving and analytical skills.

Strong communication and interpersonal skills.

Ability to work effectively with cross-functional teams.

Detailed knowledge of regulatory requirements for validation.

Experience in training and guiding teams on validation procedures.

Desirable Skills:

Previous experience in a similar role within a regulated industry.

Familiarity with the latest validation tools and technologies.

Experience in preparing and presenting validation reports.