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 point which includes 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 of working in Top Pharmaceutical client sites in a
diverse-cultural work setting. Employee Value PropositionEmployees are the “heartbeat” of PSC Biotech, we provide
unparalleled empowering career development though 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 with regards to 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.RequirementsResponsibilities:Vial and Syringe Sterile operations – Isolators, VHP,
decontamination systems.Cleaning Validation in Biotech facility & Cleaning
ProcessesSterilisation – Autoclave & Load QualificationSingle Use Technologies – SUT and SU components/
manifoldsFilter Validation – Sterilising and Bioburden reducing
Filter Validation & Process ValidationAncillary Equipment for Bio-processing – Tube Welders/
Sealers/ Filter Integrity / Glove Integrity TestingFormulation processing using DeltaV including Transfer
Panel and Utility Qualification.Parenteral Product Visual Inspection (Automated
Inspection).High Potency and ICH Q5 products & containment
methodologiesThe 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 VMPCQV approver for C&Q documents and input to
Validation strategy documents and project plans and proceduresActing as Validation SME within a team of site
representatives as system owner for PQ/ ValidationSite 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 processesFacilitate 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-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 / 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 approachSME on Equipment Qualification on any; Cleaning &
Parts Washers for in-process components / Vaporised Hydrogen Peroxide Isolators
/ Clean Utilities & Transfer Panels / Vial & Syringe Filling &
InspectionWorking 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.#LI-DM2