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:This Technical Engineering role, will play a key part in
the development of client site drug product facility.This role is to lead activities to deliver on the Tech
Transfer requirements needed to support New Product Introduction. This
includes but is not limited to: Tech Transfer, Validation programs &
strategies, Technical support and process improvement projects, network support
& collaborationThe Technical Engineering role will collaborate across
functions, supporting, coaching and facilitating project sub-teams. Together,
this dynamic group will meet the required project schedule milestones, in
accordance with the applicable standards
for Quality and EHS compliance.RequirementsResponsibilities:Safety:Work collaboratively to drive a safe and compliant
culture. Collaborate with multiple partners (eg. network groups, third
parties, vendors, quality, donor sites, Supply chain, IPT) in achieving
excellence in technical transfer programmes. Serve as technical engineering representative for internal technical
group discussions and represent Technical Engineering at Global Technical
Forums as required.Compliance:Required to comply with Global Policies, Procedures and
Guidelines,regulatory requirements and execute current Good
manufacturing Practices (cGMP) in the performance of day to day activities and
all applicable job functions, ensuring consideration of the impact on GMP and
compliance and decisions made.Required to be compliant via documentation completion,
risk assessments, closing out corrective action, participate in audits and
inspections and proactively highlighting any issues around compliance.Process Engineering & Validation:To lead and execute process engineering and validation
activities to support the technical transfersProjects:To lead and manage multiple Technical Engineering
projects needed to support the business. This includes but is not limited to:
Process improvements, capital projects and Lean projects across
multi-disciplined functions which may also require global and network support
and collaboration. Responsibility to lead an integrated project team in delivering
the project business case and collaborating closely with cross functional teams
to establish scope in improvement projects as we ramp up to a fully commercial
site.Continuous Improvement:To manage and deliver on all technical/Validation/Quality
Notification/Change control/Project support within the technical engineering
team. Use scientific, product and
process understanding as a basis for developing risk based approaches to
investigations and trouble shooting.Sponsor and foster lean six sigma and standard work
within the technical engineering Team (e.g. Structured Root Cause Analysis,
Statistical Process Control, Data driven decision making).Drive collaboration between group functions and
proactively looking for synergies and innovative ways of doing work. Constantly assessing our systems and
processes to see what improvement we can make to work smarter and more
efficiently while all the time being compliant.Technical Expertise:Act as a subject matter expert on (1) Equipment Design
(2) Assisting in C&Q execution and planning; (3) Process design and
validation.Act as a liaison with both global engineering services
and facilities as well as specialist vendors on process requirements to deliver
projects. May be required to perform other duties as assigned. Qualifications, Skills and Education Required: General:Considerable experience in a comparable role; would
typically have experience operating as a senior professional and adding
considerable value to the business. Would have process engineering and/or
validation experience in a sterile manufacturing environment and have a proven
track record in leading a technical team of engineers / scientists through
sustaining operations and technical transfer projects. Experience in leading
through change would be an advantage.Proven track-record in delivering results in a
world-class supply organisation.A strong career history in pharma (ideally aseptic
filling) and familiarity with a highly regulated environment.Innovative thinker, with excellent decision-making and
problem-solving skills.Experience of working in a cross functional environment.Knowledge of and experience in applying Six Sigma and
Lean methodologies.Positive, flexible action-oriented attitude. Technical:Knowledge of regulatory/code requirements to Irish,
European and International Codes, Standards and PracticesIn depth knowledge and experience of Sterile filling
processes and equipment especially aseptic processingExperience of executing and/or managing through equipment
and process validation in a sterile environmentGood shipping/Filter/Cleaning validation knowledge
requiredKnowledge of QbD/CPV desirableExcellent report, standards, policy writing skills
requiredAutomation and MES knowledgeProficiency in Microsoft Office and job related computer
applications requiredLean Six Sigma Methodology experience desiredExperience in audit preparation and execution desiredHaving a strong safety ethosStrong Data Analysis capabilityHave proven record of process improvement implementationProven record in planning and basic project management of
a team to deliver on time/schedule and cost People:The passion to expand the future.Ability to participate in highly-effective teams.The desire to continuously learn, improve and develop.A great communicator, decisive decision-maker with a
proven ability to deliver excellenceStrong leadership and interpersonal skills.Willingness to support the team and a strong focus on
delivering excellence.High personal integrity, credibility, energy and
flexibility.Strive to be innovative in how we do businessEngage with our business colleagues and learn from them
as well as from our own experiences Vendor liaison:Self-motivated and Flexible approachEffective time management and multi-tasking skillsExcellent attention to detailGoal/results orientatedDemonstrable analytical and systematic problem solving
skillsTraining skillsStrong change management skillsEffective conflict resolution skills Education:Degree qualification or equivalent (Science, Engineering,
Technical).Green Belt preferable Reporting to: Technical Engineering Lead#LI-AM1