Sr. Project Engineer – Process in Grand Island, NY at Apex Life Sciences

Date Posted: 8/9/2018

Job Snapshot

Job Description


Apex Life Sciences is currently recruiting for a Sr. Project Engineer.This position is responsible for providing the managerial and technical expertise necessary to direct the efforts of a project team. The project team consists of contractors from various crafts as well as members of department as assigned. Responsibilities include analysis, recommendation, implementation, cost justification and follow-up on projects designed to increase or improve productivity, capacity, or safety.

Activities:

  • Responsible for the formulation and product transfer process design and development.
  • Organizes and analyzes product specific data to design core processes according to product requirements.
  • Calculates and organizes data for process flow diagrams including instrumentation and control considerations.
  • Develops P&IDs and 3D Models of process skids and equipment as well as corresponding shop drawings and isometric drawings for field assembly.
  • Develops process specifications for formulation of conventional small molecule injectable as well as emulsion and complex formulation, including equipment skids, product delivery systems, pressure vessels, pumps, compressors, heat exchangers and all associated equipment.
  • Prepares specifications and process instructions to operate equipment.
  • Analyzes production and processing problems and initiate project definitions to resolve them.
  • Ensures timely and within budget completion of the projects as assigned by his/her manager.
  • Evaluates the feasibility of conceptual projects and prepares detailed analysis, including time and cost for completing the projects.
  • Assures that assigned projects are in compliance with State, Federal and local codes which encompass environmental protection, FDA requirements, OSHA, and hazardous waste-related issues.
  • Communicates and reports status of each project to the management and department that sponsors the project.
  • Maintains awareness of current pharmaceutical manufacturing needs and standards and initiates programs/projects to achieve the goal of facility being a state-of-the-art pharmaceutical manufacturing site.
  • Directs and coordinates activities of various vendors for each project to eliminate any potential conflict and assures that vendors comply with all the safety rules and regulations.
  • Prepares URS, Risk Assessments, Safety Assessments associated with the project.
  • Oversees the execution of the project(s).
  • Develops and maintains Process Instructions for manufacturing equipment in accordance with site Change Control and Validation requirements.
  • Identifies and Implements process improvements.
  • Identifies and specifies process-specific equipment.
  • Troubleshoots, amends and accommodates the process of aseptic formulation and fill of drug product
  • Perform any other tasks/duties as assigned by Management.

Requirements:

  • BS in Engineering
  • 5 years plant manufacturing experience.
  • 5 years hands on experience with validated manufacturing process systems.
  • 5 years of batch or continuous process system design and implementation.
  • Expertise in pharmaceutical instrumentation.
  • Process Control and Instrumentation experience.
  • Working knowledge of process engineering processing aids such as sanitary connections, valves and pharmaceutical process design.
  • Working knowledge of AutoCad or SolidWorks.
  • Must be familiar with State, Federal and local codes.
  • Knowledge of Clean Room Classifications and process flow is a plus.
  • Project Management experience in a food, pharmaceutical or regulated environment preferred.
  • Experience with critical utilities (WFI, OFCA, Clean Steam, HVAC) is desired.
  • CIP/SIP experience is desired.
  • Six Sigma Training a plus.
  • Excellent verbal and written communications skills.

If you are interested in this opportunity, please apply to: www.apexlifesciences.com and send resume to Pittsburgh@apexlifesciences.com.

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EEO Employer

Apex is an Equal Employment Opportunity/Affirmative Action Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, age, sexual orientation, gender identity, national origin, disability, protected veteran status, or any other characteristic protected by law. Apex will consider qualified applicants with criminal histories in a manner consistent with the requirements of applicable law.