management, procurement strategies and contract administration and project cost control. The CPM will work with consultants... to organize and manage teams, including internal design and operations staff, external contractors and design consultants. Proven...
. Drives the progress of consultants and contractors to achieve expected project functionality and recommend alternatives... contracts, GMP submittals, buy-out documents, pay applications, etc. Reviews plans and specifications during all phases...
auditing programs. Set strategic direction for in process and finished goods testing, stability programs, and GMP..., Certification & External Partner Governance Lead relationships with external labs, certification bodies, and regulatory consultants...
as requested by the client. Manages all sub-consultants on the project. Assists in identifying and developing innovative methods..., architecture, or planning. A minimum of 5 years of Pharmaceutical/GMP project experience. Skilled in the use of IT tools...
Client as requested by the client. Manages all sub-consultants on the project. Assists in identifying and developing...’s degree in engineering, architecture, or planning. A minimum of 5 years of Pharmaceutical/GMP project experience. Skilled...
calculations, drawings, reports, etc., directly and through supervision of other engineers. Strong understanding of GMP facility... requirements: GMP material and personnel flows, clean room design requirements, compendial water requirements, impacts of open...
and validation, and for determining product quality, purity, and stability. Analytical Operations (AO) is a non-GMP department... biotech or pharmaceutical industry is preferred. Knowledge of GMP compliance, experience with ELN, and intermediate...
for scope of work for subcontracts and purchase orders. Participates in hard bid/estimating and GMP budgeting activities... drawings, specifications, calculations, and studies. Communicates with, engineers and consultants to clarify scope of work...
project team, including sub consultants Prepare project reports for Customers (weekly/monthly or otherwise as required by the... experience in multiple project delivery Knowledge of GMP Manufacturing environments is required The ability to travel...
compliance with the Quality System and company policy. Manage interactions with R&D, Manufacturing, suppliers, and consultants... and organization skills Preferred: Experience with FDA, GMP, ASME, PED, CR, CE standards Lean / Six Sigma Certification...