About PSC Biotech
Who are we?
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 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.
Summary:
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Reporting to the BACE project manager, as part of a multi-discipline team, specifically responsible for the delivery to CQ of the project scope for an API facility.
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This candidate will be required to work closely with a cross-functional Suite teams and coordinate activities between Design, Construction, Process, Automation, Technical Operations, C&Q, Operations and QA.
Role Functions:
Reporting to BACE Project Manager.
Define and agree, with Suite team leads and the Project Manager, the physical and procedural scope and scope boundaries, within the BACE operating facility footprint.
Lead the development of, and monitoring to, project plans and successfully execute them according to the established safety, schedule, cost and performance standards.
Manage those project plans for design, construction, commissioning, qualification schedule and cost in collaboration with sub-project managers (Suite Leads) other senior project team members, operations personnel, together with outside contract and trade partners.
Lead and manage scope, budget, schedule, safety, quality and personnel discussions with the Suite Leads of the project.
In Conjunction with the Suite Leads develop, document, agree and implement an execution strategy to deliver their sub-scopes in a coordinated, controlled and well communicated manner.
Coordinate the design effort with the contract engineering firm and ensure compliance to local & Global Standards.
Facilitate engineering and user requirements for the project Suites.
Track and report progress as required against project deliverables.
Foster a strong relationship between the Client Project Team , EPCM Contractor(Integrator), Site Contractors (Trade Partners) to ensure delivery of project.
Ensure that a strong safety culture is adopted throughout the execution of the project.
Lead and facilitate the coordinated review of design material from the owner’s side including Layout reviews, P&ID/AF&ID reviews, Process Descriptions, Job Specifications, change control processes and PO’s/Data Sheets.
Facilitate the coordinated development of construction, procurement, C&Q and project control strategies into plans for the execution of the project.
Participate in Value Engineering.
Lead and attend daily communication meetings, as appropriate, with suite teams and report progress.
Maintain a clean and safe working environment by enforcing procedures, policies, and regulations.
Safety of all project team members for the duration of the design, construct, commission qualification and handover of the suite scope.
Clear, and documented, definition of scope and scope boundaries within the Suite teams.
Management of scope issues as they arise during the project
Delivery of the agreed milestones on the schedule within budget constraints.
Delivery of stakeholder agreed scope for project Suites to Commissioning Qualification.
Experience, Knowledge & Skills:
Demonstrated performance in building and managing multiple multi-functional teams.
Demonstrated performance in delivering an excellent safety record on large projects.
Experience leading projects and cross-functional initiatives.
In-depth understanding of large scale API projects, in term of unit operations, principles of automation, commissioning and qualification of the facility.
Strives for results and sets ambitious tangible and measurable targets; takes personal responsibility for achieving results; reviews and evaluates team progress against agreed targets, timelines and budgets.
Experienced of working in a GMP environment and working to a Quality System ensuring that oversight is provided in relation to project changes, that they are tracked, managed and implemented correctly ensuring alignment with any relevant regulatory requirements
Proven leadership capabilities in a prior role.
Ability to create a productive and supportive team environment and to manage or resolve any conflicts and disputes.
Able to engage and align other stakeholders outside the project team.
Ability to understand and communicate risks and develop and execute contingency plans.
Extensive experience in the operation of API processes.
Hands on experience with API unit operations.
Proven ability to lead cross-functional and technical teams and align, motivate and empower team members.
Inspires high performance by holding the team accountable for results, evaluates progress and achievement, addresses issues through appropriate channels., Makeing timely decisions with the best available information and using the appropriate decision making processes.
Ability to create, coordinate and maintain a project plan and rapidly respond to changes in strategy and project scope.
Expertise with project management tools, including skills in critical path analysis.
Understand financial and resource planning systems and processes and have ability to coordinate project level budget/resource estimates and manage actuals vs plan.
Working knowledge of process control systems and automation. DeltaV, BMS experience beneficial.
Working knowledge of C&Q documentation required for cGMP process equipment.
Fluent in English, written and verbal.
Ability to generate and communicate project plans and schedules.
Working knowledge of word processing, spreadsheets, database management software, CAD software, and PCs.
Requirements:
Bachelor of Engineering or Science Degree in Engineering or Technology related discipline.
A minimum of ten years of relevant experience in project management of larger projects in the Pharma industry including significant experience managing API projects.
A working knowledge of FDA and EU regulations is preferred.
The candidate will be a convincing communicator with strong interpersonal skills
