On behalf of Horizon Therapeutics, we are currently seeking 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. The role establishes standard work practices and supports investigations, resolves potential data integrity issues, and implements process improvements to the validated state of equipment and systems.
Responsibilities:
* Manages the qualification/requalification schedule across Drug Product manufacturing operations.
* Designs and develops validation documentation to support business continuity, new process/product introductions, and process improvement requirements.
* Oversees the preparation and execution of qualification and validation documents following established standards and templates, including but not limited to the following: Commissioning Protocols, Qualification/Validation Protocols and Summary Reports, Standard Operating Procedures, Risk Assessments, Specifications (i.e., URS), Trace Matrix (TM's)/Reliability Trace Matrix (RTM's), FATs/SATs.
* Ensures on-time execution of the schedule and reports.
* Ensures Periodic Review plans are completed per site & regulatory requirements.
* Collaborates with various departments/teams in the development and execution of validation activities associated with new equipment/product introductions and process improvements.
* Performs and assists with the execution of validation protocols (IQ, OQ, PQ) associated with the start-up and the ongoing re-qualification of equipment and processes.
* Supports regulatory inspections for both new and existing process equipment and computerized systems.
* Maintains a constant state of inspection readiness within area of responsibility and contributes to this process across the wider Validation department.
* Ensures validation activities are managed in conjunction with all company and regulatory requirements (Health & Safety, cGMP, construction, environmental, etc.).
* Provides change control assessments which could impact the validated state of process equipment.
* Leads Risk assessments, root cause analysis, and investigations as applicable.
* Owns departmental SOPs and ensures they follow corporate standards and applicable regulations.
Qualifications and Skills Required:
* Bachelor's degree (or equivalent) in Science or Technical Degree in Engineering/Life Sciences/Computer Science. Further qualifications (e.g., Masters) preferred.
* At least 15+ years relevant experience in a Biopharmaceutical manufacturing environment, with at least 10+ years' experience in Validation.
* cGMP compliance.
* Computer Systems Validation experience and understanding of applicable regulations (Annex 11, GAMP, 21 CFR Part 11).
* Capable of developing and implementing solutions to complex problems within a team dynamic using proven problem-solving techniques.
* Can interact with audits (internal and external) providing technical assurance from a quality and safety perspective.
* Proficient in Microsoft Office.
* Strong interpersonal skills.
* Excellent written and verbal communication skills.
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