Compliance Coordinator - Texas

Job Title: Validation Compliance Coordinator

Location: Texas

Provide computer system validation support for a leading contract development and manufacturing organization (CDMO) specializing in the production of biologics and advanced therapies. We are seeking a flexible and adaptable Validation Engineer to represent our team in Texas. In this role, you will be responsible for the validation strategy and SDLC documentation for various systems within the life sciences manufacturing environment.

Overview: The Validation Compliance Coordinator oversees validation deviations, CAPAs, change controls, and supports various validation activities.

Key Responsibilities:

• Coordinate and close validation deviations, CAPAs, and change controls.
• Assist with internal/external audits and prepare necessary documentation.
• Lead investigations into deviations and root causes.
• Manage equipment maintenance and calibration schedules.
• Act as point of contact for inspections and ensure compliance metrics are maintained.

Skills & Qualifications:

• Strong organizational, communication, and analytical skills.
• Experience in pharmaceutical/regulated industries, particularly in Quality Assurance.
• Bachelor’s degree in Engineering/Life Sciences or equivalent experience.
• Ability to work independently, multitask, and adapt to flexible work hours.

Physical Requirements:

• Prolonged standing, occasional lifting (up to 50 lbs), and manual dexterity. Attendance is mandatory.

Joining Valspec as a Validation Engineer (CSV) will provide you with an opportunity to make a significant impact in the validation and CSV processes for cutting-edge life sciences manufacturing systems. If you are a highly motivated and detail-oriented professional with a passion for ensuring compliance and data integrity, we encourage you to apply.