Validation Senior Engineering Specialist

Job Description

Validation Senior Engineering Specialist(s) on our Carlow Site with Technical Operations.

The successful candidate will be responsible for:

• Leadership of validation activities within the Recovery and Cleaning qualification team and across other validation teams.
• Maintaining compliance of Global Policies, Procedures and Guidelines, regulatory requirements and executing current Good Manufacturing Practices (cGMP) in the performance of day to day activities and all applicable job functions, ensuring consideration of the impact on GMP and compliance and decisions made.
• Compliance via documentation completion, risk assessments, closing out corrective actions, participation in audits and inspections and proactively highlighting any issues around compliance.
• Supporting regulatory audits and submissions as required.

Responsibilities

Bring energy, knowledge, innovation, and leadership to carry out the following:

• Planning, scheduling and oversight of Periodic Revalidation & Initial Qualification studies.
• Responsible for setting and delivery of validation strategies.
• Lead and support complex & critical investigations associated with validation and commercial activities.
• Co ordinate multiple complex projects in parallel including but not limited to New Product Introductions, Process Improvements and Investigations.
• Execution of Periodic Revalidation, Cycle Development & Initial Qualification studies as required.
• Technical review and approval of Periodic Revalidation, Cycle Development & Initial Qualification protocols & reports.
• Authoring and reviewing standard operating procedures and technical reports.
• Engage in the early stages of projects.
• Act as validation SME on the equipment within the area assigned.
• Serving as a key member during internal audits and external inspections/audits.
• Implementing the requirements as outlined in the site & project Validation Master Plan(s) and periodic revalidation plan.
• Supporting regulatory submissions.
• Lead and promote various organizational initiatives as needed (examples include EHS, workload forecasting, work standardisation, etc).
• Providing technical and validation oversight to process, design and project delivery teams.
• Represent the site in internal collaborations through Manufacturing Division Communities of Practice for Validation to include imparting of best practices in Validation and investigation activities.
• Maintain continuous focus on quality and safety compliance and unflinching focus on the customer.
• Within the role you will be acting as a validation engineer reporting within the Validation Engineering Team.

Skills and Qualifications

In order to excel in this role, you will most likely have:

• Proven history of leadership skills within current and previous roles.
• Relevant technical qualification(s) in Applied Pharmaceutical / Biological / Computer / Chemical sciences or applied Technical / Engineering qualification, with a proven track record in delivering excellence.
• A minimum of 4-5 years directly related experience in academia, pharmaceutical or biotechnology industry - along with a working knowledge of current regulatory requirements and current Good Manufacturing Practices.
• SME in Cleaning Validation for reusable parts and process vessel washing and using Automated COP and CIP systems.
• Knowledge of process monitoring systems, automation systems (DeltaV), operational intelligence & data systems (Pi System) within a GMP manufacturing environment would be beneficial and desirable.
• Experience of coaching, mentoring and leading a team in the validation department in the past is desirable.
• Prior experience in drug product processing equipment, PQ, Process Performance Qualification and Validation, site readiness, authoring documents subject to regulatory inspection.
• Knowledge of regulatory/code requirements to Irish, European and International Codes, Standards and Practices.
• Experience in working in other validation areas such CTU, Isolator and Filling Lines, Sterilisation (SIP & Autoclaves), Ancillary Qualification (Filters, CCI, Shipping) is considered advantageous but not mandatory.

Benefits

Flexible Work Arrangements: Hybrid

Visa Sponsorship: Yes

Travel Requirements: No Travel Required

Relocation: No relocation

Employee Status: Regular

EEO Statement

As an equal opportunity employer, we are proud to be a company that embraces the value of bringing diverse, talented, and committed people together.