Job Description
Horizon Therapeutics seeks a Validation Engineer Manager to join their Waterford manufacturing site on a permanent basis.
Position Summary:
The Validation Manager is responsible for the qualified state of all equipment and systems across Drug Product Manufacturing at Horizon Waterford. This role establishes standard work practices, supports investigations, resolves potential data integrity issues, and implements process improvements to the validated state of equipment and systems.
Responsibilities:
1. Manage the qualification/requalification schedule across Drug Product manufacturing operations
2. Design and develop validation documentation to support business continuity, new process/product introductions, and process improvement requirements
3. Oversee the preparation and execution of qualification and validation documents following established standards and templates, including commissioning protocols, qualification/validation protocols and summary reports, standard operating procedures, risk assessments, specifications (i.e., URS), trace matrixes/Reliability Trace Matrix (RTM'S), FATs/SATs
4. Evaluate on-time execution of the schedule and reports
5. Evaluate Periodic Review plans completion per site & regulatory requirements
6. Collaborate with various departments/teams in development and execution of validation activities associated with new equipment/product introductions and process improvements.
7. Perform and assist with the execution of validation protocols (IQ, OQ, PQ) associated with the start-up, and the on-going re-qualification of equipment and processes.
8. Support regulatory inspections for both new and existing process equipment and computerized systems.
9. Maintain a constant state of inspection readiness within area of responsibility and contribute to this process across the wider Validation department.
10. Evaluate validation activities management in conjunction with all company and regulatory requirements (Health & Safety, cGMP, construction, environmental etc.).
11. Provide change control assessments which could impact the validated state of process equipment.
12. Lead Risk assessments, root cause analysis, and investigations as applicable.
13. Own departmental SOPs and ensure they follow corporate standards and applicable regulations
Qualifications and Skills Required:
1. Bachelor's degree (or equivalent) in Science or Technical Degree in Engineering/Life Sciences/Computer Science. Further qualifications (e.g., Masters) preferred.
2. At least 15+ years relevant experience in a Biopharmaceutical manufacturing environment, with at least 10+ years' experience in Validation.
3. cGMP compliance
4. Computer Systems Validation experience and understanding of applicable regulations (Annex 11, GAMP, 21 CFR Part 11)
5. Capable of developing and implementing solutions to complex problems within a team dynamic using proven problem-solving techniques
6. Interact with audits (internal and external) providing technical assurance from a quality and safety perspective
7. Proficient in Microsoft Office.
8. Professional, proactive demeanor.
9. Strong interpersonal skills.
10. Excellent written and verbal communication skills.