About PSC BiotechWho 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 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. Role Description:Process Engineer - Tech Transfer / NPIHybrid – Day’s role with expectation to support shift
intermittently when Floor activities/studies are ongoing.New exciting opportunity now exists on our Client Site for a
Process Engineer to join the Process Engineering Group on site and report to
the Technical Engineering ManagerOur 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 groups. You will typically have prior related work
experience; ideally in manufacturing, preferably GMP Setting but we will
consider applicants from other working environments as long as they have
technology transfer experience.Knowledge of process monitoring systems, automation systems
(DeltaV), operational intelligence & data systems (Pi System) within a GMP
manufacturing environment would be beneficial and desirable but not a necessity
for this role.Our 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:Design/Author/Review/Approve/Execute
qualification/validation documentation and process development studies in line
with the standard approval process.Design/Author/Review/Approve/Execute Execution/development
of change controls.Contribution to Kaizen events as appropriateTechnical input into quality notification by
authoring/reviewing/approving investigationsExecution of equipment/qualification validation programs;
including re-qualification and re-validationSupport continuous improvement through Lean Six Sigma
methodologies.Perform root cause analysis of system failures, substandard
performance, using standard tools and methods, to resolve machine and system
issues.Serve as technical engineering representative for internal
technical group discussions and represent technical Operations at global
technical forums.Drive 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 compliance.Work collaboratively to drive a safe and compliant culture.May be required to perform other duties as assigned. Experience, Knowledge & Skills:What you will do: Bring energy, knowledge, innovation, and leadership to carry
out the following:Design/Author/Review/Approve/Execute
qualification/validation documentation and process development studies in line
with the standard approval process.Design/Author/Review/Approve/Execute Execution/development
of change controls.Contribution to Kaizen events as appropriateTechnical input into quality notification by
authoring/reviewing/approving investigationsExecution of equipment/qualification validation programs;
including re-qualification and re-validationSupport continuous improvement through Lean Six Sigma
methodologies.Perform root cause analysis of system failures, substandard
performance, using standard tools and methods, to resolve machine and system
issues.Serve as technical engineering representative for internal
technical group discussions and represent technical Operations at global
technical forums.Drive 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 compliance.Work collaboratively to drive a safe and compliant culture.May be required to perform other duties as assigned. What skills you will need:Bachelor’s Degree or higher preferred; ideally in a Science,
Engineering or other Technical disciplineMin 3 years’ experience ideally in manufacturing, preferably
GMP SettingDemonstratable experience of leading technical related
projectsEvidence of continuous professional development is
desirable.Knowledge of process monitoring systems, automation systems
(DeltaV), operational intelligence & data systems (Pi System) within a GMP
manufacturing environment would be beneficial and desirable but not a
necessity.Knowledge of regulatory/code requirements to Irish, European
and International Codes, Standards and Practices Report, standards, policy
writing skills required.Equipment and process validationSterile filling processes and equipmentProficiency in Microsoft Office and job-related computer
applications required.Excellent 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 disciplineMin 3 years’ experience ideally in manufacturing, preferably
GMP Setting#LI-KV1