Senior Validation Engineer
Senior Validation Engineer
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Job Description
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 alsobe 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:
- Oversee 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 rotas.
- 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.
Skills Brief:
- Experience working in aPharmaceutical/Medical Manufacturing environment
- Excellent project management skills
- Proficient in use of Microsoft Office suite of programs
- Critical thinking and problemsolving 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
Person Brief:
Candidates must have a relevant science or engineering tertiary qualification with a minimum of 5 years experience in the pharmaceutical or life sciences industry with strong experience of both General andComputer Systems Validation (CSV). Experience in Equipment & Process Validation would also be beneficial. Experience of GxP Computerised Systems and GAMP 5 is essential.
The ideal candidate will have excellent collaboration and communication skills with a demonstrated understanding of manufacturing processes and related process equipment. In addition to this strong attention to detail and an excellent understanding of validation concepts and documentation is required.
The role will be based in Westport and predominantly onsite. You should be living within a reasonable commute of the Sligo area and be available to be onsite daily.
Opportunity Brief:
This is an excellent opportunity to work with clients who are global leaders in their field helping to develop and improve upon industry leading technology solutions. SL Controls offers a supportive environment committed to employee development and wellness along with a competitive and rounded compensation package which rewards high performers.
Company Brief:
SL Controls are experts in the area of Equipment System Integration and System Support. We specialise in assisting our customers including many of the worlds top multinational companies in the medical device and pharmaceutical sectors achieve their Six Sigma and OEE targets.
Over the past 20 years we have grown our business from a Sligo based enterprise into an international business with additional offices in Galway Limerick Leinster and Florida USA.
We pride ourselves on our expertise in industrial IT integration and regulatory compliance in support of global end users OEMs and Technology providers.
Employment Type
Full Time
