The Role:
- Lab Validation Engineer
- 6 Month Fixed Term Contract
- Westport, Mayo
- Onsite role
Role Brief:
In this role you will be responsible for for the qualification / validation of laboratory equipment, systems and processes for an NNIT client. You also revalidate a range of mission critical systems. All validation activity will be be performed in line with GMP and FDA and other regulatory requirements. You will work with client management and business units to ensure all projects are delivered on time and budget.
Primary Responsibilities:
- Support equipment validation and potentially some CSV activities.
- Over-see, coordinate, guide and implement the site validation master plan under prospective, concurrent, and retrospective validation studies in a timely manner, with the relevant engineers. To ensure that all validation requirements are met for any new process, equipment or change to existing process or equipment.
- To 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 process for all business units & participate in design review process for all business units.
- Track and generate weekly metrics (GTW QMS, EHS, Compliance Wire etc.)
- To facilitate the PQR review process / Regulatory Review Process and Laboratory Equipment Review Process as required to meet project timelines.
- 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.
Skills Brief:
Essential:
- At least 2 years validation experience in a regulated environment.
- Proven experience writing validation equipment SOP's.
- Proven experience of setting up change controls.
- Excellent project management skills
- Strong critical thinking skills
Preferred:
- 1 years Pharma or Life Sciences manufacturing sector validation experience.
Person Brief:
- A Bachelors or Masters degree in a relevant field of study such as engineering or pharmaceutical science, quality or regulation.
- This is a role more suited to someone recently graduated with ideally 2 years experience.
- A team player looking to gain more experience and continue to develop and grow their career in the Pharma manufacturing sector.
- An individual with a current valid work permit allowing them to immediately start work in Ireland.
- An individual living in the local area or able to relocate quickly and having their own transport, as the public transport in the location is limited.
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. NNIT offers a supportive environment committed to employee development and wellness, along with a competitive and rounded compensation package, which rewards high performers.
Company Brief:
NNIT is a publicly listed company that specializes in IT solutions to life sciences internationally, and to the public and enterprise sectors in Denmark. We focus on high complexity industries and thrive in environments where regulatory demands and complexity are high. We advise on and build sustainable digital solutions that work for the patients, citizens, employees, end users or customers. NNIT employs more than 1,800 people in Europe, Asia, and USA.
