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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 cloudbased 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 likeminded 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 diversecultural work setting.
Employee Value Proposition
Employees are the heartbeat of PSC Biotech we provide unparalleled empowering career development though Learning & Development inhouse 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.
A vacancy exists within our Client Site for a Senior Project Engineer supporting capital projects.
The successful candidate will have several years experience working in the pharmaceutical or similar Industry. Reporting to the Associate Director Project Management based at the client Site. The Engineer will have previous significant experience at a senior level within a > 100MM Project.
The successful candidate will be able to demonstrate a proven track record to lead project delivery efforts and to influence others be a convincing communicator with strong interpersonal skills and strategic and tactical thinking abilities. Have knowledge of biopharma Cleanroom/HVAC/E&I equipment and utilities systems
Major/Key Accountabilities:
Ensure there is a strong safety culture and performance in the field execution of project deliverables and that appropriate stage gate controls are in place for all works coaches project team wrt to safety is involved in any investigations (near miss etc)
Works closely with CM from EPCM to develop construction team and to build a high performing team.
Attends field walk downs as client CM Representative to ensure that appropriate standards are being met with installations.
Drive initiatives such as Quality Audit Metrics Right First Time Modular Construction approach.
Completes early walk downs on systems and works with overall construction team to resolve punch lists based on priorities.
Drives systems to ensure efficient decision making within the CMT and Client Team
For construction acts as an interface with client site stakeholders to address and resolve any issues in the interfaces with site and with any external to site stakeholders.
Attends and provides inputs to Interactive Pull Planning Workshops with appointed contractors and other stakeholders to plan out construction and energisation activities in a schedule critical project identifies any constraints and works to remove these and other barriers to achieving overall aims.
Ensure that Lean Construction Tools and Methodologies are being implemented in the field (Last Planner & Pull Plan Scheduling Target Value Design and Construction Integrated Project Safety Team Structure Right FirstTime approach)
Experience with Takt Time Planning for Construction / Commissioning would be advantageous.
Ensures that EPCM has appropriate stage gate approach in place to ensure rigour in allowing systems pass from Testing: Construction Completion Energisation Commissioning.
Ensure Project Quality Standards are implemented and that documentation requirements met.
Coordinate the project construction programme incorporating.
Enabling CSA works Main CSA Works cleanroom Clean & Black Utilities generation/ Distribution Process Equipment Installation office and warehouse fit out.
Attends daily tier meetings / weekly coordination meetings regarding construction.
Reviews and approves any site field instructions and manages commercial contract variations with EPCM acts as a delegate for the client Project Manager
Completes regular walkthrough of site for safety and checks on progress etc.
Represents client in commercial negotiations and clarification meetings.
Ensures that the EPCM team manages changes in construction and ensure all are captured documented and assessed for Quality / Safety / Cost or schedule impacts.
Ensure that the EPCM manages the design construction commissioning and qualification schedule and cost in collaboration with other project team members personnel outside contractors and vendors.
Ensures that the EPCM organisation report construction progress as required against project deliverables.
Qualifications / Requirements:
Third level degree in an engineering discipline and/or a PMP in Project Management
Proven level of experience in delivering significant capital projects within the pharmaceutical sector > 100MM
Experience working in Live Facility
Hands on attitude and demonstrated ability to work with a variety of stakeholders.
Ability to sequence critical activities in planning work for construction phase.
Knowledge of clean room installation essential
Skills and Knowledge:
A minimum of 10 years of relevant experience in capital projects preferably in Pharm/Bio Pharm.
Understands the typical project life cycle from concept through to qualification and has proven experience in this area.
Proven knowledge appreciation and experience of working with Lean Construction Tools and Methodologies
Strong interpersonal skills and an understanding of the customer/client relationship involved in projects.
Excellent communication /presentation skills
Superior organizational and planning skills
Demonstrated achievements within multifunctional teams.
Additional Responsibilities:
Ensure all work is managed in accordance with client procedures and best practices.
Develop and establish oversight to ensure compliance to company/project safety and quality policies and work rules of primary trade partners.
Develop a right firsttime quality program with EPCM and partners.
Develop and establish oversight of the project job site including all logistical and regulatory requirements (i.e. approved Site Logistics Plan layout and applicable permits).
Provide development establishment and oversight of program concept strategy and execution (approved Construction Execution Plan).
Provide oversight of all construction management and administrative activities overall direction guidance issue resolution cost and schedule performance of the project.
Oversee the welfare and safety of all assigned employees (Lead safety from the top down).
Make staffing decisions selections and assignments (approved Construction organization and personnel staffing maintenance).
Develop and maintain relationship with craft (unions and nonunion) and community entities as applicable.
Provide oversight and enforcement of all applicable corporate and project policy and procedural decisions.
Maintain scope adherence and provide review / approval of all contractual changes and pay applications (as per the project change and PCN process).
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Full Time