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 points 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.Role Description:Exciting opportunities now exist on our Client Site for
Process Engineers.As Engineering Specialist, you will Lead/execute production
floor-based activities, will participate on a team of engineers, will plan and
execute C&Q, validation activities as required, as well as design and
develop engineering studies.The team currently consists of engineering professionals
working on across 4 functions on projects in collaboration with diverse teams
across Engineering, Production and Analytical Labs. Our new team member will
serve as technical support for new product introduction (NPI) and commercial
manufacturing and will participate and/or lead cross functional or single
function teams including liaising with vendors or above site groupsOur Engineers support internal and external manufacturing
operations remain operational, continuously improve, and innovate. With our
extensive range of facilities and environments, our Engineers have
opportunities across many diverse areas including Biological, Chemical,
Automation, Capital Projects, Maintenance, Safety, Process Development,
Technical Services, Utilities and Validation.RequirementsRole Functions:Bring energy, knowledge, innovation to carry out the
following:Lead/execute production floor-based activitiesParticipate on a team of engineersPlan and execute C&Q, validation activities as requiredDesign & develop engineering studiesDesign/Author/Review/Approve/Execute process development
studies in support of new product introduction and ongoing manufacturing
supportProvide technical input into quality notification by
authoring/reviewing/approving investigationsExecution of equipment/qualification validation programs;
including re-qualification and re-validationDesign/Author/Review/Approve/Execute
qualification/validation documentation and studies in line with the standard
approval processPerform data analysis and make informed
decisions/recommendations around conclusions reached from data analysisStatistical data analysis to support development and
commercialisation batchesSupport continuous improvement through Lean Six Sigma
methodologiesLeading and active participation in projects, system failure
investigations and investigation reports.Execution/development of change controlsContribution to Kaizen events as appropriatePerform root cause analysis of system failures, substandard
performance, using standard tools and methods, to resolve machine and system
issues e.g., FMEA, Fishbone diagrams, 5 why’s etcImplement subsequent corrective action through the change
management systemServe as technical engineering representative for internal
technical group discussions and represent technical Operations at global
technical forumsParticipate and/or lead cross functional or single function
teams including liaising with vendors or above site groupsDrive compliance of 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.Accountable for compliance via documentation completion,
risk assessments, closing out corrective action, participate in audits and
inspections and proactively highlighting any issues around complianceWork collaboratively to drive a safe and compliant culture. Experience, Knowledge & Skills:What skills you will need:In order to excel in this role, you will more than likely
have:Bachelor’s Degree or higher preferred; ideally in a Science,
Engineering or other technical disciplinePrior related work experience; ideally in manufacturing,
preferably GMP SettingTypically have 3 years related work experience in Aseptic
manufacturing / process engineeringKnowledge of regulatory/core requirements to Irish, European
and International Codes, Standards and PracticesReport, standards, policy writing skills requiredEquipment and process validationSterile filling processes and equipmentProficiency in Microsoft Office and job-related computer
applications requiredLean Six Sigma Methodology experience desiredExcellent communication, presentation, and interpersonal
skills, to interface effectively with all levels of colleagues and with
external customers in a team orientated manner Qualifications & Education:Bachelor’s Degree or higher preferred; ideally in a Science,
Engineering or other technical discipline#LI-KV1