Senior Validation Engineer

at  SL Controls Ltd

SKILLS BRIEF:

• Experience working in a Pharmaceutical/Medical Manufacturing environment
• 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

THE ROLE:

• Senior Validation Engineer
• Westport
• Onsite role
• Permanent or Contractor Role

ROLE BRIEF:

The successful candidate will be responsible for the qualification / validation of all CGMP equipment, systems and processes utilized for routine operation at our clients manufacturing site. You will also be responsible for ensuring conformance to quality systems, liaising with various departments, giving guidance, reviewing documentation and ensuring the company validation policies & procedures are being adhered to.

RESPONSIBILITIES:

• Over-see, coordinate, guide and implement the site validation master under prospective, concurrent, and retrospective validation studies in a timely manner, with the relevant engineers.
• Actively work on validation projects and completing all associated project documentation in line with current corporate and regulatory expectations.
• Participate in risk assessment process for all business units & participate in design review process for all business units.
• Tracking and generation of weekly metrics (GTW QMS, EHS, Compliance Wire etc.)
• To facilitate the 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. Provide support for audit preparation, direct audit interaction and involvement in audit response.
• Support and comply with internal EHS requirements, procedures and policies. Ensure continued conformance to the EMS within the department. Achieve the companies stated quality objective through continuous improvement efforts and conformance to quality standards.