Laboratory Validation Engineer Position
This is a six-month laboratory validation engineer role in the QC Pharma Department.
About the Role
The Laboratory Validation Engineer will be responsible for ensuring customer satisfaction with each revalidation, validation, and project work. This will involve actively engaging with senior management and impacted business units to manage and prioritize projects as required.
Responsibilities
* Oversee, coordinate, guide, and implement site validation master plans under prospective, concurrent, and retrospective validation studies in a timely manner.
* Actively work on validation projects, being the departmental point person and completing all associated project documentation in line with current corporate and regulatory expectations.
* Participate in risk assessment processes for all business units and participate in design review processes for all business units.
* Track and generate weekly metrics (GTW QMS, EHS, Compliance Wire, etc.).
* Facilitate PQR review processes, regulatory review processes, and laboratory equipment review processes as per current rotas.
* Keep abreast of current and changing regulatory guidance for relevant areas of validation and provide support for audit preparation, direct audit interaction, and involvement in audit response.
Qualifications
* Bachelor's degree required in a science-based or engineering discipline.
* At least two years' experience in a pharmaceutical company.
* Excellent project management skills.
* Proficient in using Microsoft Office suite of programs.
* Critical thinking and problem-solving skills.
* Ability to articulate clearly when dealing with internal and external bodies.
* Excellent conflict handling skills.
* Expertise in relevant subject matter areas – example Equipment, Facility, Aseptics, Process, CPV, CSV, Cleaning.
Requirements
* Estimated Salary: $80,000 - $100,000 per year.