Senior Project Engineer (cGMP - Pharmaceutical)

We are looking for a knowledgeable Engineering resource to join our Life Sciences team in support of a pharmaceutical project in the Indianapolis area. Ideal candidates should have a strong understanding of capital project engineering lifecycle and experience providing Project Engineering support in highly regulated or pharmaceutical/biotech facilities.

AMTS has opportunities throughout the country and overseas supporting multiple locations in MA, NH, RI, NC, Europe, and other locations.

Responsibilities:

· Provide engineering and technical support related to operation, maintenance, design, installation, start-up/commissioning, testing and qualification of product and infrastructure equipment and systems.

· Systems may include production equipment such as bioreactors, fermenters, centrifuges, UFDF, Chromatography, CIP skids, and other support equipment such WFI, CS, Process Gases, HVAC, and Core Building Utility Systems.

· Support the design and qualification of improvements, changes or upgrades to the equipment and startup and validation documents.

· Lead projects of various complexities to support departmental initiatives and participate in various cross-functional teams to support process improvements.

· Identify and schedule project events around manufacturing operations.

· Identify materials required to support project execution work.

· Communicate project requirements to vendors to obtain proposals for equipment and piping changes.

· Provide project design and cost estimates.

· Manage project implementation including oversight of selected vendors.

· Redline drawings to prepare the As-Built set and maintain the site master drawing.

· Report project status and progress to Senior Project management.

Education and Experience:

· Bachelor’s degree in Mechanical or Chemical Engineering.

· Minimum 3+ years’ experience providing Project Engineering support.

· Candidate must be able to work across functional areas such as operations, maintenance, quality and validation.

· Proficiency in the arena of process, utility and building engineering in cGMP environment within a biopharma facility.

· Working knowledge of documents such as P&IDs, URS, FRS, and qualification documents.

· Effective verbal and written communication skills.

· Excellent interpersonal, teamwork, and leadership skills required.