Laboratory Specialist

Validation Engineer

We are seeking a skilled Validation Engineer to oversee the validation of laboratory equipment, systems and processes.

Responsibilities:

• Coordinate and implement site validation master under prospective, concurrent, and retrospective validation studies in a timely manner with relevant engineers.
• Work on validation projects as departmental point person, completing all associated project documentation in line with corporate and regulatory expectations.
• Participate in risk assessment process for business units, participate in design review process for business units.
• Track and generate weekly metrics related to QMS, EHS, Compliance Wire.
• Facilitate PQR review process, Regulatory Review Process, and Laboratory Equipment Review Process as per current rota's.
• Stay up-to-date with current and changing regulatory guidance for relevant areas of validation, provide support for audit preparation and direct audit interaction.
• Support and comply with internal EHS requirements, procedures and policies, ensure continued conformance to EMS within the department.
• Provide support for audit preparation, direct audit interaction, and involvement in audit response, participate in site internal and external audit program.

Qualifications:

• 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 relevant subject matter areas such as Equipment, Facility, aseptics, Process, CPV, CSV, Cleaning.