SHINE Technologies is seeking a Validation Engineer to ensure systems, processes and products meet specified requirements and regulatory standards in the commercial manufacturing facility.
Requirements
- Experience in cGMP environments
- Strong understanding of validation principles, methodologies, and regulatory requirements.
- Experience in drafting and executing qualification documents (IQ, OQ, PQ).
- Ability to write procedures and protocols and review documentation.
- Ability to analyze data, identify risks, and develop effective solutions.
- Ability to identify and resolve issues related to validation and compliance.
- Experience with Computer Software Validation (CSV) documentation
Responsibilities
- Developing and Implementing Validation Strategies
- Create and maintain validation protocols and reports, ensuring they align with regulatory requirements and project goals.
- Lead the development of risk assessments in relation to validation activities.
- Coordinate and help execute approved protocols for process validation, equipment installation and operational qualification (IQ/OQ), performance qualification (PQ), and requalification/revalidation of critical systems and utilities.
- Provide input and guidance on new and existing validation projects including facility systems, manufacturing equipment and processes, analytical instrumentation, and cleaning processes.
- Review FDA and EMA regulations to ensure the validation activities meet defined requirements.
- Perform periodic reviews of system(s) validation and reporting for the Annual Quality Product Review.
Other
- BS in scientific discipline or equivalent other work experience
- Previous experience of 3-5 years in validation activities associated with pharmaceutical or medical device company is preferred
- Ability to lead and motivate teams, manage projects, and communicate effectively.
- Excellent written and verbal communication skills for interacting with cross-functional teams and stakeholders.
- Eligibility for employment is conditioned on the applicant’s ability to qualify for access to information subject to U.S. Export Controls.
