Senior CQ/ Validation Engineer

About PSC Biotech

Who are we?

PSC Biotech is a leading Biotech Consultancy firm founded in 1996, headquartered in Pomona, California, USA, with global operations in Ireland, India, Singapore, Australia, and the US, serving 350 clients in more than 23 countries worldwide. We provide cloud-based software solutions for Quality Management and Regulatory Inspections, pharmaceuticals contract manufacturing professionals, and metrology services to our clients.

'Take your Career to a new Level'

PSC Biotech disrupts the conventional consultancy model by aligning our EVP as one of the unique selling points which include the opportunity to work with the most talented cohort of like-minded professionals operating in the Pharma/Biotech Industry. We offer a permanent contract of employment giving exposure to working in top pharmaceutical client sites in a diverse cultural work setting.

Employee Value Proposition

Employees are the "heartbeat" of PSC Biotech; we provide unparalleled empowering career development through Learning & Development in-house training mentorship through constant guidance to facilitate career progression. We believe in creating high-performing teams that can exceed our client's expectations regarding the quality of all scalable and business unit deliverables, staying under budget and ensuring timelines for our deliverables are being met.

Overview:

An exciting opportunity has come to join the science, engineering/manufacturing & commercialisation team to support the transition of the facility from construction & project phase to a commercialisation of fully operational facility delivering life-saving products to patients.

Responsibilities:

• Vial and Syringe Sterile operations – Isolators, VHP, decontamination systems.
  
• Cleaning Validation in Biotech facility & Cleaning Processes
  
• Single Use Technologies – SUT and SU components/manifolds
  
• Filter Validation – Sterilising and Bioburden reducing Filter Validation & Process Validation
  
• Ancillary Equipment for Bio-processing – Tube Welders/Sealers/Filter Integrity/Glove Integrity Testing
  
• Formulation processing using DeltaV including Transfer Panel and Utility Qualification.
  
• Parenteral Product Visual Inspection (Automated Inspection).
  
• High Potency and ICH Q5 products & containment methodologies
  
• The successful candidate should have demonstrated experience in at least 2 of these key areas and alongside new facility introduction experience. The successful candidate will be involved in the project from Operational Qualification (OQ) through to the Equipment Performance Qualification, Validation and Product PQ – including filing with regulatory bodies.
  
• Levels of responsibility will vary during this timeframe as outlined below –
  
• Managing the workload and providing coaching for a team of Validation Engineers within the assigned area working on;
  
• Aligning new facility introduction with Validation approach across site and review and approval of project VMP
  
• CQV approver for C&Q documents and input to Validation strategy documents and project plans and procedures
  
• Acting as Validation SME within a team of site representatives as system owner for PQ/Validation
  
• Site Acceptance Test – Attendance, hands-on support and C&Q Oversight for assigned process equipment.
  
• Working with the C&Q Lead to ensure consolidated & compliant approach to C&Q and readiness for CQV crossover into right-first-time Validation/PQ executions.
  
• Commissioning & Qualification – Hands-on support & Oversight for assigned process equipment.
  
• Cycle Development – Execution of Cycle Development pre and post OQ phases for assigned process equipment.
  
• Performance Qualification – Responsibility for /Execution of Performance Qualification testing for assigned process equipment.
  
• Liaising with Tech Transfer team to ensure product requirements are met.
  
• Ownership of updates to Technical SOPs related to Validation and assigned process systems.
  
• Managing site change controls as part of QMS implementation of the new facility as required.
  
• Ensuring that PQ and Validation are aligned with the regulatory & market requirements for filing the new facility and product licensure at the close out of the project.
  

Role Functions:

• Within the role you will be acting as a technical SME & Senior CQ/Validation Engineer reporting within Technical Engineering at Tier 1 and Tier 2 level as required.
  
• Work within a team of Validation professionals from 'Intern' level to Associate Director to own and execute the Validation & PQ aspects of the project.
  
• Oversee equipment C&Q within the assigned area with a view to ensuring right first-time C&Q and Validation effort.
  
• Act as SME on the process & equipment within the assigned area.
  
• Providing technical and validation oversight to process, design and project delivery teams and coaching to associate personnel within the assigned area.
  
• Implementing the requirements as outlined in the site & project Validation Master Plan(s).
  
• Coordination of engineering sub-teams in the assigned area 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 area for qualification/validation up to PQ stage.
  

Effective application of Lean Six Sigma and Change Management tools in the Validation group by:

• Leading by example in achieving results by using industry standard tools and processes
  
• Facilitate problem solving & risk assessment (FMEA) projects/meeting.
  
• Make problems visible and strive for continuous improvement.
  
• Serving as a key member during internal audits and external inspections/audits.
  
• 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 as required in internal collaborations through Manufacturing Division Communities of Practice (CoP) for Validation and C&Q to include sharing of best practices in C&Q/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:

• This role requires an experienced individual with a minimum of 6 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-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 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/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 6 years C&Q/QA/QC/Validation experience in highly regulated industry.
  
• Minimum 2 years process equipment C&Q/QA/Validation experience on Greenfield/Brownfield, Large Scale Project or new facility introduction.
  
• Presenting of QA/QC/Validation documents to regulatory agencies/inspectors and defending approach.
  
• SME on Equipment Qualification on any; Cleaning & Parts Washers for in-process components / Vaporised Hydrogen Peroxide Isolators/ Clean Utilities & Transfer Panels / Vial & Syringe Filling & Inspection.
  
• Working knowledge of ASTM E2500 / Eudralex / FDA / ISPE guidelines.
  
• Experience with liaising with other departments – Engineering, Automation, Technical, Operations, EHS and QA.
  
• Prior experience in drug product processing equipment, PQ, Process Performance Qualification and Validation, site readiness, batch record reviews, authoring documents subject to regulatory inspection.
  

Desirable but not essential;

• Vial & Syringe processing technologies; drug product filling, glass handling, tray handling, stoppering, capping and CCI.
  
• Clean Utilities and HVAC system Qualification.
  
• New facility brown/green field facility introduction experience, or training & developing a team within a commercial manufacturing environment.
  
• Small equipment qualification and validation; FITs, Scales, Tube Sealers/Welders, Headspace analysers, Flowmeters, Mobile Vessels & Single Use Technologies.
  
• Experience with sterile processing and sterilisation technologies is advantageous.
  
• Experience with cleaning and process validation, technology transfer, regulatory filing, and commercial drug product manufacturing of biologics is a plus.
  
• Project Management experience/training in use of Project Management tools and software tools.
  
• Use of Delta V and associated new Phase development and Qualification works.
  

Qualification:

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