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Manufacturing Validation Specialist

2 months ago

Austin, Texas, United States ICU Medical Full time

FLSA Status: Exempt

Position Overview
Responsible for executing validation tasks, including the development and implementation of protocols, while assessing qualification and validation statuses under the mentorship of senior engineers and managers. This role provides an opportunity to engage with complex responsibilities within the operational framework. The position is characterized by a blend of independence and teamwork, focusing on completing intermediate to advanced projects with limited oversight.

Key Responsibilities

• Lead and implement validation activities for manufacturing systems, utilities, and facility validations to support various projects.

• Draft validation plans, protocols, and reports tailored to specific initiatives.

• Conduct risk assessments related to validation for specific projects, facilities, and products.

• Independently gather, organize, and analyze validation data, keeping management informed of progress and challenges.

• Address diverse problems requiring analytical evaluation of identifiable factors.

• Operate largely autonomously once tasks are assigned, while occasionally seeking guidance from senior engineers.

• Employ innovative solutions to resolve complex challenges.

• Integrate subsystems and components into comprehensive system designs.

• Develop specifications based on customer requirements.

• May oversee others during project-specific tasks and provide training to new or existing employees regarding documentation, equipment usage, laboratory techniques, and departmental protocols. May contribute to performance evaluations for team members.

• Communicate effectively with various stakeholders (managers, peers, customers) to ensure clarity and promote cross-functional collaboration.

• Address conflicts and disagreements openly, striving for collaborative resolutions and consensus.

• Participate in special projects as needed.

Knowledge & Skills

• Strong understanding of validation and regulatory standards.

• Proficient in validation strategies with the ability to propose solutions to critical challenges.

• Capable of making impactful decisions that affect project success and related functions.

• Advanced knowledge in tech-transfer, process validation, and cleaning validation, with familiarity in other relevant areas.

Minimum Qualifications, Education & Experience

• Must be at least 18 years of age.

• A bachelor's degree from an accredited institution is required.

• 4-7 years of experience in validation, scientific/technical, or engineering roles is necessary, with a preference for pharmaceutical validation or engineering experience.

• Alternatively, a master's degree with 2 years of relevant experience will also be considered.

Work Environment

• This role is primarily sedentary.

• Operates within a professional office setting and utilizes standard office equipment.

• Work is conducted in a clean room environment.

• Must be able to occasionally lift and move objects weighing up to 25 pounds.

• Travel requirements are typically less than 5%.