Sr. Engineer (Biotechnology Industry) 3547376

ProQuality Network; Northern (KY); Hybrid; USD 100,000 - 150,000; Full time

Job summary

ProQuality Network has contracted a Senior Engineer to lead process optimization initiatives in a highly regulated biotechnology manufacturing environment. The role requires hands-on problem solving and the ability to collaborate with operations, quality, validation, facilities, and capital projects teams.

The ideal candidate will bring advanced engineering expertise, strong cGMP experience, and a track record of managing complex projects from concept through execution.

Qualifications

• Advanced engineering degree with relevant biotech/pharma background.
• Experience with cGMP procedures and validation practices.
• Experience with change control and CAPA processes.

Responsibilities

• Execute complex or novel assignments requiring new or improved engineering techniques.
• Develop engineering policies impacting multiple units.
• Supervise and review work of engineers and technicians.
• Apply advanced engineering methodologies within area of expertise.
• Serve as a technical specialist in at least one discipline.
• Plan and conduct projects with mature engineering judgment.
• Support additional engineering functions as assigned.
• Develop technical solutions to complex challenges.
• Partner with cross-functional teams to define requirements for large-scale modifications.
• Collaborate with project managers to deliver projects within scope, schedule, budget, and quality.

Skills

Leadership

Project management

Cross-functional collaboration

Technical writing

Problem solving

Regulatory compliance

Operational troubleshooting

Education

Doctorate in Engineering

Master’s + 2 years relevant experience

Bachelor’s + 4 years relevant experience

Tools

Maximo

Job description

Sr. Engineer (Biotechnology Industry) 3547376

Title: Sr. Engineer (Biotechnology Industry) – 3547376

Shift: Administrative (8 hours)

Duration: Approximately 6 Months

Positions Available: 1

Professional Summary

This opportunity is available by contract through ProQuality Network to support our client in the biotechnology industry. We are seeking a seasoned Senior Engineer who can independently lead process optimization initiatives, troubleshoot operational challenges, and drive engineering projects within a highly regulated manufacturing environment. This role requires strong technical expertise, hands‑on problem solving, and the ability to collaborate across operations, quality, validation, facilities, and capital projects teams. The ideal candidate brings advanced engineering knowledge, solid cGMP experience, and the leadership capability to manage complex projects from concept through execution.

Position Overview

The Senior Engineer will independently provide and/or direct process characterization, optimization strategies, and resolution of operational issues across manufacturing, pilot plant, operations, and capital project environments. This role applies advanced engineering principles to the design and implementation of major system modifications, experiments, and capital improvements.

The selected candidate will develop, organize, analyze, and present interpretations of results for operational and engineering initiatives of significant scope and complexity.

Preferred Qualifications

• Bachelor’s Degree in Engineering (Mechanical, Electrical, or Chemical preferred)
• Excellent written and verbal communication skills
• Strong technical writing experience
• Working knowledge of cGMP procedures and engineering practices within pharmaceutical/biotech manufacturing processes, facilities, and equipment
• Experience with change control, nonconformance investigations, CAPA, and validation practices
• Experience with Maximo
• Ability to generate and manage Purchase Orders (POs)
• Experience coordinating and escorting vendors and contractors
• Strong multitasking and project prioritization skills
• Self‑motivated, organized, and collaborative team player
• Flexibility to support 24/7 operations, including occasional after‑hours engineering coverage

Key Responsibilities

• Execute complex or novel assignments requiring the development of new or improved engineering techniques and procedures
• Develop engineering policies and procedures impacting multiple organizational units
• Supervise, coordinate, and review the work of engineers, associates, and technicians
• Apply advanced engineering methodologies within area of expertise
• Serve as a recognized technical specialist in at least one engineering discipline
• Plan and conduct projects using mature engineering judgment
• Support additional engineering functions as assigned
• Develop technical solutions to complex engineering challenges requiring creativity and ingenuity
• Partner with research, manufacturing, process development, utilities, facilities, quality assurance, and validation teams to define requirements for large‑scale system or facility modifications
• Collaborate with project managers to deliver engineering projects within scope, schedule, budget, and quality expectations
• Coordinate consultants, architects, and engineering firms in the development of standard design documentation
• Develop departmental or multi‑disciplinary project budgets

Education Requirements

• Doctorate in Engineering
• OR
• Master’s Degree + 2 years of relevant engineering experience
• OR
• Bachelor’s Degree in Engineering + 4 years of relevant engineering experience

Core Competencies

• Strong knowledge of pharmaceutical/biotech manufacturing processes
• Familiarity with validation processes and protocol execution
• Experience working in highly regulated environments (GLP/GMP)
• Technical report writing and presentation skills
• Applied engineering problem‑solving abilities
• Ability to manage multiple projects simultaneously
• Knowledge of validation requirements for new equipment installations
• Analytical and scientific problem‑solving skills using engineering theory and calculations
• Financial analysis and project cost development knowledge
• Leadership, negotiation, and contractor/vendor management skills
• Conflict resolution and team facilitation capabilities
• Ability to determine when additional internal or external resources are required