Industry Pharma/Biotech/Clinical Research
Work Experience 4-5 years
City Dublin
State/Province Dublin
Country Ireland
Job Description
About PSC Biotech
Who are we?
PSC Biotech is a leading Biotech Consultancy firm foundedin 1996, headquartered in Pomona, California, USA, with Global operations inIreland, India, Singapore, Australia and the US, serving 350 clients in morethan 23 countries worldwide.
We provide cloud-based software solutions forQuality Management and Regulatory Inspections, pharmaceuticals contractmanufacturing professionals, and metrology services to our clients.
'Take your Careerto a new Level'
PSC Biotech disrupts the conventional consultancy modelby aligning our EVP as one of the unique selling point which includes theopportunity to work with the most talented cohort of like-minded professionalsoperating in the Pharma/ Biotech Industry.
We offer a permanent contract ofemployment giving exposure of working in Top Pharmaceutical client sites in adiverse-cultural work setting.
Employee ValueProposition
Employees are the "heartbeat" of PSC Biotech, we provideunparalleled empowering career development though Learning & Developmentin-house training mentorship through constant guidance to facilitate careerprogression.
We believe in creating high performing teams that can exceed ourclient's expectations with regards to quality of all scalable and business unitdeliverables, staying under budget and ensuring timelines for our deliverablesare being met.
Overview:
The MS&T Process Engineer delivers a range oftechnical support to the Drug Substance Business: leading technicalinvestigations within the Integrated Process Team, supporting significantprojects across the site, supporting design, construction and qualification ofupstream & downstream equipment (when applicable), NPI/technology transferand commercialization .
The MS&T Process Engineer ensures that MS&Tteam objectives are effectively achieved, consistent with the requirements to ensurecompliance, safety and reliable supply to our customers, while creating aninclusive culture that energizes a Safety First, Quality Always, continuousimprovement mindset.
Requirements
PrimaryResponsibilities:
Drive compliance of Global Policies, Procedures andGuidelines, regulatory requirements and execute current Good manufacturingPractices (cGMP) in the performance of day to day activities and all applicablejob functions, ensuring consideration of the impact on GMP and compliance anddecisions made.
Design/Author/Review/Approve/Execute qualificationdocumentation in line with the standard process.
Leads experimental design of studies, execution, dataanalysis and interpretation.
Authors and reviews batch documentation,regulatory and technical documentation
Interpret trends observed in commercial processmonitoring (e.g., proactive process analysis (PPA), continued processverification (CPV), statistical process control (SPC) multivariate analyses(MVDA)), and for further technical investigations and process changes that seekto drive improvements to yield and/or robustness.
Support the execution of development and PPQ batches,change control management and implementation
Lead multidisciplinary teams (manufacturing science andtechnology, quality, analytics, regulatory) for process improvement andtroubleshooting with end-to-end product focus through Lean Six Sigmamethodologies.
Lead and facilitate investigations, ensuring effectiveRoot Cause Analysis and CAPAs.
Participate in audits and inspections.
Lead and/or support various site initiatives to improvecompliance status and overall operational efficiency of the site.
Serve as akey member during internal audits and external inspections/audits
Lead and support various MS&T organizationalinitiatives as needed (examples include safety, financial forecasting, workstandardization, etc).
Maintain continuous focus on quality and safetycompliance and unflinching focus on the customer.
Qualification andExperience:
Demonstrated leadership and change management skills witha continuous improvement focus.
Proven track record of delivering high performancethrough development and coaching of a team.
Evidence of continuous professional development.
Strong collaboration to promote knowledge sharing andimplementation of best practices across the site.
Motivation to be an inspiring member of a high performingteam and passion to build the future Desire to continuously learn, improve anddevelop.
Demonstrated interpersonal skills including flexibility,collaboration and inclusion skills and ability to work/ upskill/coach a teamenvironment.
Technical:
SME in upstream/downstream processing and process controlstrategies.
Working knowledge of analytics.
Knowledge of process monitoring systems, automationsystems (DeltaV), operational intelligence & data systems (Pi System)within a GMP manufacturing environment.
Knowledge of regulatory/code requirements to Irish,European and International Codes, Standards and Practices.
Evidence of continuous professional development.Technical writing skills.
Ability to effectively articulate understanding biologicsprocesses, in order to drive decision making, impact assessments, design ofstudies, etc., in a multi-disciplinary team environment.
Working knowledge of statistical process control (SPC),multivariate analysis (MVDA), and/or process analytical technologies (PAT)techniques for biologics processes.
MinimumEducation/Experience:
Relevant technical qualification(s) in Applied Pharmaceutical/ Biological / Chemical sciences or applied Technical / Engineeringqualification
Experience leading technical related projects.
Experience with upstream cell culture and/or downstreampurification ofbiological molecules.
Experience in preparing for and presenting in front ofregulatory audits as SME.
Experience with technology transfer, regulatory filingand commercial drug substance manufacturing of biologics is a plus.
Technical operations experience in the drug substancemanufacture of biological molecules at commercial-scale.
Prior experience in drug substance process development,process characterisation studies, process performance qualification andvalidation, site readiness, batch record reviews, authoring regulatory CTDsections and/or working with external contract organization for developmentand/or manufacturing.
Experience in change management, deviations and CAPAsmanagement.
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