About PSC Biotech Who we are? 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 Proposition Employees 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.Job Title: CQV Engineer. Role Description:As part of a significant expansion of the client site, an
exciting opportunity has come to join the science, engineering/ manufacturing
& commercialisation team to support the high potency facility from
construction, 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 –· 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.RequirementsRole Functions:The successful candidate will be involved in the project
from Detailed Design, Construction, Site Acceptance Test (SAT) at the earliest,
responsible for C&Q deliverables and follow assigned systems through to
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 project lifecycle· Cycle Development – Execution of Cycle
Development pre and post OQ phases· 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 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 C&Q SME on the equipment within the
area assigned. · As such you will be executing with a view to
leveraging testing from Commissioning and Qualification to PQ where possible.· 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 / C&Q and project Validation Master Plan.· Coordination of engineering sub-teams in the
assigned suite during 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 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.· Support various organizational initiatives as
needed (examples include EHS, workload forecasting, work standardization, etc).· 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. Experience, Knowledge & Skills:Preferred Experience and Skills:· 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.· 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.· 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 use
of Project Management tools. Qualifications & Education:· 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-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, 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.#LI-BR1