17398-GSEC CQ & Validation-Carlow Contractor

This role is an 11 month contract with a view to extension.

Purpose

There are 4 broad technical areas that will require the leadership of experienced, energetic, and committed engineers.

Sterilisation & Temperature Mapping – Autoclaves & CTUs Cleaning – Parts Washer.

Vial and Syringe (and cartridge) filling operations – Glass handling, Tray & Tub handling, Drug Product Filling, and Parenteral Product Visual Inspection.

Vial and Syringe Sterility operations – Isolators, VHP, Fill Finish ancillary equipment – FIT, GIT, Tube Welders/ Sealers.

The successful candidate will need to have demonstrated in-depth experience in 3 or more of these areas.

Responsibilities

• The successful candidate will be involved in the project from Detailed Design, Construction, and Site Acceptance Test (SAT) at the earliest, responsible for C&Q deliverables, and follow assigned systems through to the Equipment Performance Qualification, Validation, and Product PQ – including filing with regulatory bodies.

• Each role will be involved in the project from the vendor Factory Acceptance Test (FAT), at the earliest, through to the Performance Qualification.

• Levels of responsibility will vary during this timeframe as outlined below.

• Factory Acceptance Test – Attendance, hands-on support, and C&Q Oversight.

• Installation to Mechanically Complete – C&Q Oversight.

• Commissioning & Qualification – Hands-on support & Oversight throughout the project lifecycle.

• Cycle Development – Execution of Cycle Development pre and post-OQ phases.

• Facilitate problem-solving & risk assessment (FMEA) projects/meetings.

• Make problems visible and strive for continuous improvement.

• Serving as a key member during internal audits and external inspections/audits.

• Support various organizational initiatives as needed (examples include EHS, workload forecasting, work standardization, etc).

• Keep up to date with scientific and technical developments, and best practices and attend seminars as required.

• Maintain continuous focus on quality and safety compliance and unflinching focus on the customer.

Requirements

• This role requires an experienced individual with a minimum of 3 years directly related experience in academia, pharmaceutical, or biotechnology industry – along with a working knowledge of current regulatory requirements and current Good Manufacturing Practices. Applicants with less than 3 years of direct experience may be considered for future, more junior roles.

• A self-starter and results-focused, the successful candidate will have strong contemporary knowledge, and the ability to work independently and on multidisciplinary teams.

• The successful candidate will also have demonstrated the ability to deliver what is needed on time, holding self and team members accountable for commitments, decisions, actions, and behaviors.

• S/he will also have excellent oral and written communication skills, with the ability to effectively articulate understanding of process science, drive decision making, impact assessments, design of studies, etc., in a multi-disciplinary team environment.

• With relevant technical qualification(s) in Applied Pharmaceutical / Biological / Chemical sciences or applied Technical / Engineering qualification, the successful candidate will also have a proven track record in delivering excellence.

• The candidate will also show ambition and drive to develop and advance within the role.

• Performance Qualification – Responsibility for / Execution of all Performance Qualification testing.

THE EXPECTATIONS

Within your chosen role you will be acting as an intermediate engineer reporting within the GSEC model to the Technical Engineering department, the role will include,

• Engage in the early stages of the project, giving input into the design by working with equipment vendors and global engineering teams, attending FAT and design reviews to represent client validation interests. Oversee equipment C&Q within the assigned area to ensure right-first-time C&Q and Validation effort.

• Act as C&Q SME on the equipment within the area assigned.

• As such you will be executing leveraged testing from Commissioning and Qualification to PQ where possible.

• Providing technical and validation oversight to process, design, and project delivery teams and coaching associate staff within the assigned suite.

• Implementing the requirements as outlined in the site / C&Q and project Validation Master Plan.

• Coordination of engineering sub-teams in the assigned suite during the g execution of IQ/OQ / Cycle Development & Validation activities.

• Authoring and reviewing standard operating procedures and technical reports including IOC/ IOQ & PQ protocols.

• Technical owner of Commissioning protocols, Qualification protocols, and input to Validation protocols executed by vendors, cross-functional groups, and/ or validation counterparts.

• Supporting regulatory submissions as required.

• Input to Change Management process for Equipment introduction within the assigned suite for qualification/validation up to the PQ stage.

• Effective application of LeanSixSigma and Change Management tools in the Validation group by:

• Leading by example in achieving results by using industry-standard tools and processes.

Preferred Experience and Skills: 

• Minimum 3 years of process equipment C&Q/ Validation experience on Large Scale Projects.

• SME on Equipment Validation on any of; Parts Washer / Autoclaves / Vaporised Hydrogen Peroxide Sterilising Isolators / Clean Utilities – Transfer Panels & Formulation / Visual Inspection/ Single Use Technologies.

• Working knowledge of ASTM E2500 / Eudralex / FDA / ISPE guidelines / Revised Annex 1.

• Experience with liaising with other departments – engineering, technical, operations, and QA.

• Experience with sterile processing and sterilisation technologies.

• Experience with cleaning and process validation, technology transfer, regulatory filing, and commercial drug product manufacturing of biologics is a plus.

• Prior experience in drug product processing equipment, PQ, Process Performance Qualification and Validation, site readiness, batch record reviews, and authoring documents subject to regulatory inspection.

• Autoclave Qualification and Sterilisation Loads Cycle Development experience.

• Use of temperature mapping equipment such as Lives/ Kaye etc. and trending, analysing, and interpreting complex data.

Desirable but not essential

• Visual Inspection technologies for Vial & Syringe.

• Vial & Syringe processing technologies; drug product filling, glass handling, tray handling, stoppering, capping, and CCI.

• Formulation and Clean Utilities C&Q along with Single-Use Technologies.

• Warehouse and CTU qualification advantageous.

• New facility brown/ green field facility experience.

• Small equipment qualification and validation; FITs, Scales, Tube Sealers/ Welders, Headspace analysers, Flowmeters, Mobile Vessels & Single Use Technologies.

• Project Management experience/training in the use of Project Management tools.