Project/Process Engineer
22 hours ago
Job Description
About PSC Biotech
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 to 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 through 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 regarding quality of all scalable and business unit deliverables, staying under budget and ensuring timelines for our deliverables are being met.
Overview:
You will join our Project Engineering Group (CPEG), part of the larger Technical Engineering Department, with responsibility to lead an integrated project team in delivering the project business case. Responsibilities include but are not limited to: process improvements, capital projects, and Lean projects across multi-disciplined functions which may also require global and network support and collaboration.
Requirements
Role Functions:
- Manage projects from scope development, design, build/install, and qualify through to handover to operations for key Technical Engineering projects.
- Maintain contact with the Project Sponsors to ensure engineering solution development remains aligned with the project’s business case.
- Responsible, with the Project Manager, for the development and maintenance of the scope, budget, and timelines. Adequately resource core team in support of scope and schedule targets.
- Coordinate and present the typical project Stage Gates to off-site Capital Approval Committee.
- Use scientific, product, and process understanding as a basis for developing risk-based approaches to investigations and troubleshooting that will feed into future projects.
- Develop project scope, cost, and delivery time schedule for all Tech Eng projects, working and collaborating closely with Technical engineering leads to ensure integration into ongoing Validations and/or Technical transfers.
- Collaborate closely with cross-functional teams to establish scope in improvement projects as we ramp up to a fully commercial site.
- Act as a subject matter expert on: equipment design and qualification; assisting in C&Q execution planning; system boundary definition, system level and component criticality impact assessments, use of quality risk management, User Requirement Specs and requirements traceability matrices, Document Management Systems, FAT/SAT and C&Q protocol development, project implementation.
- 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 and support continuous improvement by active participation in projects, system failure investigations and investigation reports, execution/development of change control, and contribution to Kaizen events as appropriate. Perform 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 etc.; implement subsequent corrective action through the change management system.
- Integration of Computer Systems Validation activities, in collaboration with Automation/IT partners, into required projects.
- Drive collaboration between groups within the Technical Engineering function proactively looking for synergies and innovative ways of doing work.
- Constantly assess our systems and processes to see what improvement we can make to work smarter and more efficiently while all the time being compliant.
- Act as a liaison with both global engineering services and facilities as well as specialist vendors to deliver projects on time and in full as required by the business.
- Work collaboratively to drive a safe and compliant culture.
- May be required to perform other duties as assigned.
Experience, Knowledge & Skills:
- Experience as a Capital Projects Team Lead for large capital projects (>$5MM) preferable.
- 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.
- Knowledge of regulatory/code requirements to Irish, European, and International Codes, Standards, and Practices.
- In-depth knowledge and experience of Sterile filling processes and equipment especially aseptic processing.
- Experience of executing and/or managing through equipment and process design and validation in a sterile environment.
- Knowledge of QbD/CPV desirable.
- Excellent report, standards, policy writing skills required.
- Automation and MES knowledge.
- Proficiency in Microsoft Office and job-related computer applications required.
- Experience in audit preparation and execution desired.
- Having a strong safety ethos.
- Excellent communication, presentation, and interpersonal skills, to interface effectively with all levels of colleagues and with external customers in a team-oriented manner.
- Understand the specific responsibilities, functions as they relate to one’s own department as well as the network governance groups.
- Proven record in planning and basic project management of a team to deliver on time/schedule and cost.
- Proven contractor and vendor management.
- Focus on Customers and Patients.
Qualification:
- Bachelor Degree or higher preferred; ideally in a Science, Engineering, or Other Technical discipline. Green Belt preferable.
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