Validation Engineer

THE ROLE

As part of a significant expansion of the site, an exciting opportunity has come to join the Commercialisation team to transition from a project phase to a fully operational facility delivering life-saving products to patients.

THE AREA

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

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(1) Sterilisation & Temperature Mapping - Autoclaves & CTUs

(2) Cleaning - Parts Washer

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

(4) Vial and Syringe Sterility operations - Isolators, VHP

(5) Fill Finish ancillary equipment - FIT, GIT, Tube Welders/ Sealers

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 project lifecycle

· Cycle Development - Execution of Cycle Development pre and post OQ phases

· Performance Qualification - Responsibility for / Execution of all Performance Qualification testing.

Role Functions

(Functions include, but are not limited to, the following)

THE EXPECTATIONS

Within your chosen role you will be acting as a senior engineer reporting within the Technical Engineering department, the role will include -

· Engage in the early stages of the project, giving input into 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 with a view to ensuring right first-time C&Q and Validation effort.

· Act as validation SME on the equipment within the area assigned. As such you will be leveraging testing from Commissioning and Qualification.

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

· Implementing the requirements as outlined in the site / project Validation Master Plan.

· Coordination of engineering sub-teams in the assigned suite during execution of Cycle Development & Validation activities.

· Authoring and reviewing standard operating procedures and technical reports including PQ protocols.

· Technical review and approval of Commissioning protocols, Qualification protocols and Validation protocols executed by vendors, cross functional groups and/ or validation counterparts.

· Supporting regulatory submissions as required.

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

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

o Leading by example in achieving results by using industry standard tools and processes

o Facilitate problem solving & risk assessment (FMEA) projects/meeting.

o Make problems visible and strive for continuous improvement.

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

o Supporting alignment and knowledge exchange with development organizations, other commercial nodes and external manufacturing partners.

· Lead and support various organizational initiatives as needed (examples include EHS, workload forecasting, work standardization, etc).

· Represent the site in internal collaborations through Manufacturing Division Validation Communities of Practice to include sharing of best practices in validation and investigation activities.

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

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

· Execution in line with the site Continued Process Validation (CPV) program and supporting cross-site CPV as needed.

Experience, Knowledge & Skills

THE QUALIFICATIONS / EXPERIENCE

This role requires an experienced individual with a minimum of 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.

A self-starter and results-focussed, 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 behaviours.

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

With relevant technical qualification(s) in Applied Pharmaceutical / Biological / Computer / 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.

Preferred Experience and Skills:

• Minimum 3 years 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, 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.
• 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 use of Project Management tools.

Qualifications & Education

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