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.
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.
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