Job Description
We are seeking a highly skilled Validation Engineer to join our team at Team Horizon for an 18-month contract. This role offers a unique opportunity to coordinate the development and maintenance of our site validation program, ensuring compliance with external regulatory, quality, and compliance requirements.
Responsibilities:
* Coordinate the validation and qualification of site equipment, utilities, processes, and software in compliance with policies, FDA, European cGMP, and GAMP standards.
* Generate validation and qualification protocols and final reports to cGMP standards.
* Investigate validation issues and implement corrective actions.
* Create, review, and approve various qualification documents and test data.
* Manage validation, exception event, and change control processes.
* Maintain and track engineering equipment, if applicable.
* Complete all required training before executing a task.
* Document all activities in line with cGMP requirements.
* Update engineering procedures, job instructions, and forms to reflect current best practices.
* Cross-train within the team and train new team members.
* Participate in continuous improvement programs to implement improvements in manufacturing, quality, safety, and training systems.
* Coordinate activities to maximize the effectiveness of all team members.
* Maintain overall cGMP compliance of the engineering areas.
* Communicate with peers and management regarding activities in the area, including elevation of events or concerns.
* Work as part of cross-functional internal and corporate teams.
* Provide reports, schedules, and timelines for qualification projects in progress to the engineering manager.
* Assign resources to qualification activities.
* Liaise with vendors on system definition and design qualification.
Requirements:
* 3+ years of validation experience in medical device plastics processing, moulding, or assembly operations.
* A minimum of 3 years' experience in a cGMP regulated environment.
* 3+ years of knowledge of cGMP and regulatory requirements relating to the medical device industry.
* 2+ years of experience validating in a highly automated environment.
* Strong communication (written and oral), presentation, and troubleshooting skills.
* Effective interpersonal and organizational skills.
* Ability to work well both independently and in a team environment.
* Capable of prioritizing work and multitasking.