CSA Lead

A global leading biopharmaceutical client requires a CSA lead experienced in large design and construction projects to join their new biotech manufacturing facility

LOCATION: Dublin, Ireland

START: September 2015

DURATION: Initial 12 month contract (min. 2 years' work)

REPORTING TO: Life Science Cell Culture (LSCC) Project Manager

MAIN RESPONSIBILITIES

Lead Engineer/SME for CSA (GMP/Non GMP buildings), initially responsible for review of all Design deliverables from JE including Drawings, Datasheets, specifications and Engineering Lists.

Point person for Vendor review for all CSA Vendor Packages- including GMP Clean Room facilities, Cold rooms and freezers and Architectural Office and Lab finishes.

Acts as a consultant to the Engineering firm to ensure design meets client's requirements.

Partners with Engineering firm counterparts to identify opportunities to reduce cost and schedule.

Acts as a facilitator to obtain client's buy in into design approval process.

Liaises with Corporate Global engineering counterpart

Leads data/comments gathering on behalf of client; expedites decision making affecting design in support to engineering deliverables in line with project schedule.

Leads CSA SWAT Team in relation to punch list closure both pre-M/C and during the CQV execution phase.

Liaise with CQV and Lead Scheduler in relation to schedule creation and management for all CSA Systems, ensuring all correct predecessors and successors are in place.

Ensure Commissioning readiness of all CSA Systems to support Start-up

Liaises with other disciplines to ensure alignment and coordination across disciplines

Leads CSA's scope redlining exercise.

Liaise with all Project Groups - (Design/CM/CQV/Automation/Process/SMEs/Ops/Maintenance/PMs) to ensure all CSA Systems are managed appropriately for the entire Project Lifecycle.

Provides feedback on the procurement of discipline related packages, ensuring that items purchased are to the correct specification and orders are placed in line with schedule requirements

Works closely with the CM, project and owner teams to develop a baseline schedule which supports project completion date.

The role will particularly focus on the elements of the schedule relating to facility readiness including procurement, commissioning, Training and Qualification along with the review/approval of documentation in support of these activities.

Work closely with construction to develop a construction schedule which reflects the needs of the primary Discipline equipment and supports the start-up needs.

Once a base line schedule has been developed, to work with the Commissioning Manager to identify ways in which the schedule can be accelerated and to mitigate against identified areas of schedule risk.

Ensure system is thoroughly checked on receipt at the construction site or site warehouse for damage and shipment completeness. Make sure it is stored in a way that provides for easy retrieval and protection.

Ensure proper installation details and studies are developed and that it is protected at the soonest opportunity following installation.

Partner with CM to ensure quality of installation follows client's requirements and expectations.

Participate with CM on the inspection and approval of First in Place's.

Co-ordinate with CM and system owners during walk downs and agree the categorisation of punch items, sign off mechanical completion certification.

EXPERIENCE AND CONTACTS

Minimum 10 years CSA experience on Large Scale Projects within the Biotech Industry; preferably Cell Culture facilities, Cold Chain warehouse and Admin/Lab offices

SME on GMP facilities including experience on Clean Room Wall systems and Cold Rooms, minimum 10 years

Experience with liaising with other departments and building PMs/leads, ensuring streamlined CSA scheduling and planning for all buildings, including LSCC, LOCclean room systems, cold rooms, admin building and lab.

Experience with complex projects and working in or around operating facilities.

Ability to keep work pace and meet deadlines. Good organising and planning skills.

Demonstrated proficiency communicating and collaborating at a variety of levels with customers, vendors, equipment suppliers and operations staff.

Proven success working well in a team environment with flexibility to react to changing business needs.

Strong leadership and communication skills. Problem solver with a focus on achievement of overall project goals.

Computer skills (Spreadsheets, Word Processing, Visio, Microsoft Project).

If you are interested in this opportunity or you are able to recommend someone, please contact Virginie Taffin or (see below).