Senior Engineer ProQN 710

Frey Consulting Group; Juncos (PR); On-site; USD 90,000 - 120,000; Full time

Job summary

The Senior Engineer position at Frey Consulting Group focuses on characterizing, optimizing, and troubleshooting complex processes within manufacturing, operations, pilot plant, and capital projects.

The role applies advanced engineering principles to design and implement major system modifications, process improvements, experiments, and capital projects, and involves delivering technical results and recommendations for challenging engineering programs.

Qualifications

• Experience in manufacturing and process optimization.
• Knowledge of GMP and GLP requirements.
• Ability to lead cross-functional teams.

Responsibilities

• Lead complex engineering assignments and develop new techniques.
• Develop policies and procedures impacting multiple units.
• Supervise engineers and technicians on projects.
• Apply advanced engineering methods to a range of tasks.
• Collaborate across departments to define requirements for system modifications.
• Coordinate with external vendors and contractors on design activities.

Job description

Work Schedule: On-site | Administrative Shift

Shift Requirements: Must be available to work different shifts and/or weekends based on business needs

Position Available: 1

Contract Duration: 6 months

This opportunity is available exclusively to direct individual candidates. Submissions from third-party contractors, staffing vendors, agencies, or Corp-to-Corp (C2C) arrangements will not be considered.

Position Summary

The Senior Engineer independently provides and/or leads the characterization, optimization, and troubleshooting of complex processes and operational issues within manufacturing, operations, pilot plant, and capital project environments.

This role applies advanced engineering principles to the design and implementation of major system modifications, process improvements, experiments, and capital projects. The Senior Engineer is responsible for developing, organizing, analyzing, and presenting technical results and recommendations for operational challenges and engineering projects of significant scope and complexity.

The successful candidate will work collaboratively across engineering, manufacturing, process development, utilities, facilities, quality assurance, and validation functions while providing technical leadership and practical solutions to complex problems.

Key Responsibilities

• Lead complex or novel assignments requiring the development of new or improved engineering techniques, methods, and procedures.
• Develop engineering policies and procedures that may impact multiple organizational units.
• Supervise, coordinate, and review the work of engineers, associates, and/or technicians on both ongoing and project-based assignments.
• Apply advanced engineering techniques and adapt established methodologies within the applicable engineering discipline.
• Apply engineering knowledge across related technical disciplines to support a broad range of assignments.
• Serve as a recognized technical specialist in at least one area of engineering technology and provide guidance on appropriate methodologies.
• Apply mature engineering judgment to plan, execute, and deliver complex projects.
• Independently identify technical challenges and determine when additional internal or external resources are required.
• Manage multiple projects while maintaining schedule, quality, and business objectives.
• Develop technical solutions to complex engineering problems requiring ingenuity, creativity, and sound technical judgment.
• Collaborate with Research, Manufacturing, Process Development, Utilities, Facilities, Quality Assurance, and Validation teams to develop requirements and recommendations for major or highly complex system and facility modifications.
• Partner with project managers to execute design and engineering projects within established schedule, budget, and quality requirements.
• Coordinate consultants, architects, engineering firms, contractors, and vendors involved in engineering and design activities.
• Develop standard design documentation and technical deliverables.
• Support the development of departmental and project budgets, including projects involving multiple engineering disciplines.
• Support project cost development, financial analysis, and resource planning.
• Delegate and manage project activities performed by other engineers, contractors, vendors, and technical personnel.

Validation & Regulated Environment

• Apply engineering principles within highly regulated pharmaceutical and biotechnology environments.
• Support validation activities associated with new equipment installations, systems, processes, and facility modifications.
• Demonstrate a comprehensive understanding of validation protocol execution requirements.
• Apply GMP and GLP requirements to engineering and operational activities.
• Prepare and review technical reports, validation documentation, and engineering deliverables.
• Support documentation requirements within a highly regulated environment.
• Apply specialized equipment and process knowledge to engineering and validation activities.