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:

• 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.
  
• 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.
   
  

Requirements

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