Job Description
A fantastic opportunity has arisen for a Specialist, Engineering, MS&T, Q&V.
You will be an active member within the cross functional team providing support and guidance and will strive for technical excellence to ensure the success of the Q&V team.
Bring energy, knowledge, innovation to carry out the following: Lead/Execute/Participate in Equipment and System Validation Lifecycle processes, Qualification (IQ/OQ/PQ), Revalidation, Requalification and Equipment Periodic Reviews, for Equipment and Systems.
Coordinate with and guide other departments or outside contractors/vendors to complete validation tasks.
Participate in CSV Validation Lifecycle processes, Qualification (RS/QAP/UAT etc), CSV Periodic Reviews, for Equipment and Systems.
Participate and comply with the Manufacturing Division Quality Management System (QMS) requirements, including ownership, as relevant.
Investigate and troubleshoot problems which occur and determine solutions or recommendations for changes and/or improvements.
Execute/Participate in change controls and other compliance related tasks e.g. non-conformances.
Support regulatory audits.
Lead/Support Shipping Qualification and/or Cleaning Verification/Validation activities.
Work on own initiative to maintain adherence to schedule of activities including run the business and project workloads.
Support, lead or guide others in CQV projects.
What skills you will need:
Hon. Degree in a Science or Engineering discipline.
Experience in a GMP environment essential.
Minimum 5 years' experience in a similar role.
Demonstrated knowledge in pharmaceutical/biopharmaceutical technical manufacturing operations, with experience of successfully delivering technical projects.
Knowledge of Regulations and applicable standards for Quality, Safety, Regulatory.
Demonstrated high level of complex problem solving and attention to detail.
Demonstrated capability of working and collaborating across multiple functional teams.
Demonstrated capability to deliver results RFT, in an FDA/HPRA Regulated production environment.
Stakeholder management of multiple decision makers, corporate colleagues, cross-functional team by demonstrating the ability to maintain and strengthen trust relationships with people on all level.
As a company, we are committed to 'Inventing for Life' in all that we do.
We keep the patient at the very heart of all that we do and strive to find solutions and treatments for some of the world's most challenging healthcare needs.
As an equal opportunity employer, we are proud to be a company that embraces the value of bringing diverse, talented, and committed people together.
Please don't hesitate to contact the Talent Acquisition Advisor assigned to this role should you need any support during our recruitment process.
We are committed to flexible working where possible, and this is why our Company has introduced a new hybrid working model for office-based colleagues around the world.
So, if you are ready to: Invent solutions to meet unmet healthcare needs, please apply today
Employee Status:
Regular
Relocation:
Not Applicable
VISA Sponsorship:
Not Applicable
Travel Requirements:
Not Applicable
Flexible Work Arrangements:
Hybrid
Shift:
Not Applicable
Valid Driving License:
Not Applicable
Hazardous Material(s): Not Applicable
Job Posting End Date: 12/12/2024
*A job posting is effective until 11:59:59PM on the day BEFOREthe listed job posting end date. Please ensure you apply to a job posting no later than the day BEFORE the job posting end date.
Requisition ID:
R324084
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