Position: Senior Specialist, Commissioning, Qualification and Validation Engineer
Location: Dublin
Duration: 12 Month
Working with Us
Challenging. Meaningful. Life-changing. Those aren't words that are usually associated with a job. But working at us is anything but usual. Here, uniquely interesting work happens every day, in every department. From optimizing a production line to the latest breakthroughs in cell therapy, this is work that transforms the lives of patients, and the careers of those who do it. You'll get the chance to grow and thrive through opportunities uncommon in scale and scope, alongside high-achieving teams rich in diversity. Take your career farther than you thought possible.
We recognize the importance of balance and flexibility in our work environment. We offer a wide variety of competitive benefits, services and programs that provide our employees with the resources to pursue their goals, both at work and in their personal lives.
Position Summary
This role of CQV Engineer will be responsible for commissioning, qualification, and validation activities at the company relating to GMP and non-GMP equipment/system types across multiple projects. Commissioning involves testing systems prior to operations to confirm the correct installation and establishing that it's functioning as intended while complying with Good Engineering Practices and EHS requirements. Qualification involves testing quality-impacting equipment by verifying the necessary functionality required for the end-user and is focused on Good Manufacturing Processes through documenting IQ, OQ and PQ. Validation processes continue throughout the lifecycle by collecting ongoing performance data to ensure the validated state remains.
This position will report to the Senior Manager, Validation and will be focused on the sustaining validation element of the lifecycle, involved in delivering requalification and periodic reviews of qualified equipment and systems. The role will be expected to adhere to schedules, execute validation testing, generate GMP documentation, provide regular updates to management, and troubleshoot and investigate issues as required. There will also be opportunities to become involved in cleaning validation and CQV project work as the role progresses.
Key Responsibilities
* Generating and completing CQV documentation to satisfy requirements and executing test deliverables for requalification and periodic review testing as applicable.
* Adhering to deadlines as scheduled by the team leader.
* Inputting to a wider CQV team and liaising with cross-functional teams to ensure timely completion and approval of CQV deliverables.
* Investigation support using QMS (Quality Management Systems) and troubleshooting for CQV issues.
* Ensuring adherence to governing site and global procedures and regulatory guidelines.
Qualifications & Experience
The candidate should hold a minimum of a BS qualification (Degree) in a scientific, technical, or engineering discipline.
* Previous CQV experience is an advantage, previous GMP experience is essential.
* The ideal candidate would have biopharmaceutical Process / Validation knowledge.
* Exposure to cGMP in a fast-paced environment is required.
* Previous experience in working in a drug product filling facility would be advantageous.
If you come across a role that intrigues you but doesn't perfectly line up with your resume, we encourage you to apply anyway. You could be one step away from work that will transform your life and career.
Uniquely Interesting Work, Life-changing Careers
With a single vision as inspiring as "Transforming patients' lives through science ", every employee plays an integral role in work that goes far beyond ordinary. Each of us is empowered to apply our individual talents and unique perspectives in an inclusive culture, promoting diversity in clinical trials, while our shared values of passion, innovation, urgency, accountability, inclusion, and integrity bring out the highest potential of each of our colleagues.
On-site Protocol
Physical presence at the worksite or physical presence in the field is a necessary job function of this role, which the Company deems critical to collaboration, innovation, productivity, employee well-being and engagement, and it enhances the Company culture.
We dedicated to ensuring that people with disabilities can excel through a transparent recruitment process, reasonable workplace accommodations/adjustments and ongoing support in their roles. Applicants can request a reasonable workplace accommodation/adjustment prior to accepting a job offer. We care about your well-being and the well-being of our staff, customers, patients, and communities. As a result, the Company strongly recommends that all employees be fully vaccinated for Covid-19 and keep up to date with Covid-19 boosters.
We will consider for employment qualified applicants with arrest and conviction records, pursuant to applicable laws in your area.
Any data processed in connection with role applications will be treated in accordance with applicable data privacy policies and regulations.
Pride Global offers eligible employee's comprehensive healthcare coverage (medical, dental, and vision plans), supplemental coverage (accident insurance, critical illness insurance and hospital indemnity), 401(k)-retirement savings, life & disability insurance, an employee assistance program, legal support, auto, home insurance, pet insurance and employee discounts with preferred vendors.