Role Overview:
We are seeking a Laboratory Validation Engineer to join our team. This role will involve ensuring customer satisfaction with each revalidation, validation, and project work.
The successful candidate will be responsible for overseeing, coordinating, guiding, and implementing site validation masters under prospective, concurrent, and retrospective validation studies in a timely manner. They will also work on validation projects, completing associated documentation in line with current corporate and regulatory expectations.
Key Responsibilities:
* Oversee, coordinate, guide, and implement the site validation master under prospective, concurrent, and retrospective validation studies in a timely manner.
* Actively work on validation projects, being the departmental point person, and complete all associated project documentation in line with current corporate and regulatory expectations.
* Participate in risk assessment process for all business units and participate in design review process for all business units.
* Track and generate weekly metrics (GTW QMS, EHS, Compliance Wire).
* Facilitate PQR review process/Regulatory Review Process and Laboratory Equipment Review Process as per the current rota's.
* Keep abreast of current and changing regulatory guidance for the relevant areas of validation that applies.
* Support and comply with internal EHS requirements, procedures, and policies. Ensure continued conformance to the EMS within the department.
* Provide support for audit preparation, direct audit interaction, and involvement in audit response. Participation in site internal and external audit program (to include periodic review).
Requirements:
* Bachelor's degree required in science-based or engineering discipline.
* Experience in Pharmaceutical company.
* Excellent project management skills.
* Proficient in use of 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 the relevant subject matter areas – example Equipment, Facility, Aseptics, Process, CPV, CSV, Cleaning.