Senior Engineer ProQN771

Frey Consulting Group; Juncos (PR); On-site; USD 120,000 - 180,000; Full time

Job summary

Frey Consulting Group is seeking a Senior Engineer to independently characterize, optimize processes, and troubleshoot operations within manufacturing, pilot plants, or capital projects. You will design and implement major system modifications, run validations, and present results to cross-functional teams.

Ideal candidates hold advanced engineering degrees with extensive experience in regulated environments, GMP/GLP, protocol writing, and project management, and demonstrated ability to lead

Qualifications

• Doctorate in Engineering or MS with 2+ years of experience.
• BS in Engineering with 4+ years of experience.
• Experience with validation processes and regulatory documentation (GMP/GLP).
• Knowledge of pharmaceutical/biotech production environments.

Responsibilities

• Lead complex process optimization and troubleshooting efforts.
• Develop, validate, and implement major system modifications and capital projects.
• Prepare technical reports, validation docs, and engineering-related material.
• Coordinate diverse stakeholders and manage multiple projects to completion.

Skills

Process optimization

Troubleshooting

GMP/GLP

Project management

Technical reporting

Cross-functional collaboration

Communication skills

Contractor coordination

Change management

Analytical problem solving

Team leadership

Education

PhD in Engineering

MS in Engineering (2+ yrs exp)

BS in Engineering (4+ yrs exp)

Job description

Work Schedule: Onsite – Administrative Shift

Positions Available: 1

SUMMARY

Our client is seeking a Senior Engineer to independently provide and/or direct the characterization of process optimization strategies and troubleshooting of operational issues within operations, manufacturing, pilot plant, or capital project environments.

The position applies advanced and diverse engineering principles to the design and implementation of major system modifications, experiments, process improvements, and capital projects. The Senior Engineer develops, organizes, analyzes, and presents results and interpretations related to operational issues and engineering projects of significant scope and complexity.

Required Qualifications

• Doctorate in Engineering; or
• Master’s degree in Engineering with at least 2 years of engineering experience; or
• Bachelor’s degree in Engineering with at least 4 years of engineering experience.
• Working knowledge of pharmaceutical or biotechnology processes.
• Knowledge and application of engineering principles to production and operational environments.
• Experience with validation processes, including protocol writing and execution.
• Experience with regulated documentation and GMP/GLP requirements.
• Ability to develop, analyze, and interpret technical information and results related to engineering projects and operational issues.
• Ability to troubleshoot technical problems and develop practical engineering solutions.
• Ability to prepare technical reports, validation documentation, and engineering-related documents.
• Ability to manage multiple projects, establish schedules, coordinate activities, and follow through to completion.
• Ability to work independently and determine when internal or external resources are required.
• Ability to collaborate effectively with cross-functional teams and adapt to different communication and working styles.
• Working knowledge of project management principles, including project coordination, cost development, resource management, and follow-up.
• Ability to communicate technical information effectively through written and verbal communication and technical presentations.
• Ability to apply analytical problem-solving, engineering principles, scientific theory, calculations, and creative approaches to technical challenges.
• Ability to manage change and support technical equipment and process-related activities.
• Ability to coordinate contractors, vendors, consultants, architects, and engineering firms as required.
• Ability to facilitate collaboration, negotiate, resolve conflicts, and support team leadership and development.
• Established expertise in at least three engineering technology areas.

Preferred Qualifications

• Experience in general packaging or engineering within pharmaceutical or biotechnology final-product manufacturing.
• Strong knowledge of GMP and GDP requirements.
• Strong knowledge of pharmaceutical primary and secondary packaging materials, including: Bottles, Labels, Trays, Lidding, Leaflets, Paperboard, Sterile barrier packaging & Corrugate
• Familiarity with distribution testing, including ASTM D4169, as well as applicable ASTM, ISO, TAPPI, USP, and EP standards.
• Experience writing test protocols and technical evaluations and conducting testing to support technical reports and the selection or qualification of materials and packaging components.
• Strong interpersonal, project management, technical problem-solving, and communication skills.
• Experience developing or improving engineering techniques and procedures.
• Experience developing engineering policies or procedures affecting multiple organizational units.
• Experience supervising, coordinating, or reviewing the work of engineers, associates, or technicians.
• Experience supporting complex system or facility modifications in collaboration with Research, Manufacturing, Process Development, Utilities, Facilities, Quality Assurance, and Validation.
• Experience working with project managers to complete design and engineering projects within established schedule, budget, and quality requirements.
• Experience coordinating consultants, architects, and engineering firms on design documentation.
• Experience developing departmental or project budgets involving multiple disciplines or smaller projects.
• Experience developing technical solutions for complex engineering problems requiring ingenuity and creativity.

FUNCTIONS

• Complete complex or novel assignments requiring the development of new or improved engineering techniques and procedures.
• Develop engineering policies and procedures that affect multiple organizational units.
• Supervise, coordinate, and review the work of engineers, associates, and/or technicians on an ongoing or project basis.
• Apply advanced engineering techniques and modify established techniques within the applicable area of engineering expertise.
• Apply engineering principles and practices outside the primary area of discipline to a broad range of assignments in related fields.
• Serve as a recognized engineering technology specialist in at least one area, with overall responsibility for determining methodologies within that area.
• Apply mature engineering knowledge to the planning and execution of projects.

Other functions may be assigned.

• Develop technical solutions to complex problems requiring ingenuity and creativity.
• Collaborate with Research, Manufacturing, Process Development, Utilities, Facilities, Quality Assurance, and Validation departments to develop requirements and recommendations for large-scale or highly complex system and facility modifications.
• Work with project managers to complete design and engineering projects within established schedule, budget, and quality constraints.
• Coordinate the work of consultants, architects, and engineering firms in the development of standard design documents.
• Develop departmental or project budgets encompassing multiple disciplines within a project or for smaller projects.