What are the responsibilities and job description for the Project Engineer position at Union Agener?
Position Description, Functions, Duties, and Tasks:
- Lead the full lifecycle of capital projects, from initial conception and feasibility studies to detailed design, procurement, construction, commissioning, and validation, ensuring alignment with project design requirements.
- Manage and coordinate all aspects of assigned projects, including defining project scope, developing detailed engineering specifications and drawings, securing management approval.
- Oversee the development of User Requirements Specifications (URS) and Functional Requirements Specifications (FRS), manage equipment acceptance testing (factory and on-site), conduct equipment risk assessments and criticality assessments, and provide direct support for commissioning, Installation Qualification (IQ), Operational Qualification (OQ), and Performance Qualification (PQ) protocols.
- Provide technical expertise and guidance throughout the project lifecycle, ensuring that all engineering designs meet the required performance, safety, and regulatory standards.
- Develop and manage project budgets and schedules, ensuring projects are delivered on time and within budget constraints.
- Contribute to process improvement initiatives and assist in troubleshooting activities, identifying opportunities to enhance efficiency, reduce costs, and improve product quality.
- Ensure compliance with cGMP, FDA, OSHA and other relevant regulatory requirements, practicing and maintaining accurate documentation.
- Support investigations of safety and quality incidents and contribute to the development of Corrective and Preventive Actions (CAPA) as needed.
- Facilitate project team meetings.
- Revise and review Engineering related SOP’s, engineering drawings, and other engineering related documentation.
Minimum Qualification (Education, Experience and/or Skills, Required Certifications):
Education:
- Bachelor’s degree in engineering (Mechanical, Chemical, or Electrical Engineering preferred).
Experience:
- Minimum of 5 years of experience in process or project engineering with a biotechnology, pharmaceutical, or related manufacturing plant environment.
- Demonstrated experience managing capital projects from conception to completion in a cGMP regulated environment is essential.
Required Skills:
- Expertise in concurrently managing three (3) to five (5) projects of varying complexity.
- Practical experience in management and coordination associated with the execution of capital projects, managing contractors and consultants.
- Strong understanding of equipment design principles and application within a manufacturing environment
- Strong technical writing skills for writing specifications, SOPs, validation protocols and reports.
- Strong initiative and focus on achieving results.
- Proficient with Microsoft Office suite.
- Time Management Skills
- Budget Management Skills
- Strong problem-solving ability and focus on innovation.
- Good interpersonal and verbal communication skills.
Preferred Qualifications
- Working knowledge of statistical process control tools (e.g., Six Sigma).
- Experience with SAP (CMMS) or similar enterprise asset management systems.
- Developing expertise of process equipment (e.g. piping, tanks, pumps, instrumentation) and control systems within a pharmaceutical/biotech manufacturing setting
Other Information:
Physical Demand Requirements:
- Must be able to perform and review work in a manufacturing plant environment. This includes ascending/descending ladders and stairs and wearing appropriate personal protective equipment.
- Incumbent’s duties may involve internal/external work in various climate/weather associated with a manufacturing plant at any time. The incumbent is expected to respond to plant emergencies when required.
