Project Engineer Biologics Jobs (NOW HIRING)

Position Summary: 

The Project Engineer designs, specifies and commissions new and renovated biopharmaceutical process and clean utility equipment; provides engineering support and leads deviation investigations for equipment and manufacturing processes. As Project Engineer you will be responsible to provide the Project Manager with assistance required to attain or exceed the project operating income, project execution plan and customer satisfaction goals. Day-to-day activities include, but are not limited to, designing, reviewing, estimating, labor management and tracking, enhancing customer relationships, and scheduling responsibilities. 

Responsibilities:

· Ability to work in a professional team-based office environment and meet date-driven customer focused commitments.

· Keep assigned Project Manager(s), Project Team Members and Departmental Management Supervisor apprised of project workload progress, needs and updates on a regular basis.

· Monitor all project costs & identify any scope of supply changes affecting project cost.

· Function as direct customer contact on technical items related to assigned projects.

· Prepare & update ‘Project Scope Report’.

· Supports Project Manager activities and responsibilities on “as-needed” bases when required or when the Project Manager is not available.

· Work to meet all departmental Goals, Objectives and Metric based improvement initiatives.

· Review, generate and comprehend customer-based specifications, requirements and proposal documents. 

· Review & analysis of customer specifications with respect to company offer, scope of supply & commercial terms.

· Prepare & maintain contract files in accordance with Company procedures.

· Support Company Designers on Engineering-related deliverables while meeting customer expectations for equipment requirements related to form, fit and function.

· Support the creation and approval of key Engineering / Design documentation (i.e. P+ID’s, GA’s, Detailed Design Drawings, BOM’s).

· Perform calculations required for equipment verification and component / system sizing.

· Preparation of specifications, equipment data sheets, and technical review of vendor quotes.

· Support design verification activities and participate in Design-driven Model reviews.

· Review and Approve related Engineering Change Notices (ECN’s) and ensure their accuracy and completeness prior to their publication and release throughout the organization (i.e. purchasing, quality, production).

· Support Automation and Electrical Engineering Resources on related deliverables driven by customer expectations related to equipment communications and / or functionality.

· Work with company Automation resources to review customer requirements and generate / approve related automation documentation including but not limited to Functional Requirement Specifications (FRS) and Detailed Design Specifications (DDS).

· Support Manufacturing and Quality based resources in their work to fabricate, assemble and qualify Engineering / Design deliverables in support of customer driven requirements.

· Function as company contact on technical items related to assigned projects under fabrication and quality verification

· Supervision and/or conduct FAT and/or SAT activities both domestically and internationally.

· Generate required test plans and work with customers to seek approval in advance.

· Support the development of engineering standards, procedures & procedures for review by departmental management.

· Support Departmental and Organizational efforts to improve performance and reduce operational costs by identifying potential items for consideration, and participating in company sponsored process improvement teams as assigned.

· Travel to customer job sites as required.

· Execute other tasks as assigned.

· Will play an active role in identifying and driving Continuous Improvement (CI) opportunity.

Requirements

· BS in an Engineering field (Mechanical, Biological, Chemical or equivalent experience).

· 3 years post graduate Engineering experience in related industry preferred.

· Preferred experience of 5 years post graduate Engineering experience working in a BioPharm or Piping systems market and / or direct experience supporting the manufacture and testing of custom equipment, machinery and components driven by customer specifications.

· 2 years’ experience in support of automation and control systems engineering related to bioprocesses preferred.

· Awareness of and prior experience with implementing Continuous Improvement (CI) a plus.

· Prior Lean/Six Sigma experience a plus.