Senior Engineer-PRQN 800

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

Job summary

ProQuality Network is seeking a Senior Engineer to independently lead process characterization, optimization strategies, and troubleshooting of operational issues within manufacturing, pilot plant, or capital project environments. The role requires developing and presenting technical results related to complex issues and engineering projects.

The Senior Engineer will provide technical leadership, collaborate across multiple functions, and support large-scale system modifications and capital

Qualifications

• Doctorate in Engineering, or Master’s in Engineering with 2+ years of engineering experience, or Bachelor’s in Engineering with 4+ years of experience.

Responsibilities

• Lead complex process characterization, optimization strategies and troubleshooting in operations, manufacturing, pilot plant or capital projects.
• Develop and implement major system modifications and capital projects with technical leadership across functions.
• Collaborate with Research, Manufacturing, Process Development, Utilities, Facilities, Quality Assurance, and Validation teams.
• Coordinate consultants, architects and engineering firms for standard design documentation.
• Develop budgets and support cost development and financial analysis for projects.
• Manage multiple projects with prioritization and follow-up, delegating work as needed.

Skills

Leadership

Project management

Negotiation

Collaboration

Problem solving

Analytical thinking

Delegation

Vendor management

Education

Doctorate in Engineering

Master's degree in Engineering + 2 years experience

Bachelor's degree in Engineering + 4 years experience

Job description

Work Schedule: Onsite – Administrative Shift

Availability: Must be available to work different shifts and/or weekends as business needs require

Contract: 6 months

Positions Available: 2

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

Position Summary

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

The selected candidate will apply advanced engineering principles to the design and implementation of major system modifications, experiments, process improvements, and capital projects. This role requires the ability to develop, organize, analyze, and present technical results related to complex operational issues and engineering projects.

The Senior Engineer will also provide technical leadership, collaborate across multiple functions, and support projects involving significant scope and complexity.

Key Responsibilities

• Complete complex or novel engineering assignments requiring the development of new or improved engineering techniques 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 modifications within the candidate's area of expertise.
• Apply engineering knowledge and principles across related disciplines and fields.
• Serve as a recognized engineering technology specialist in at least one area, with responsibility for determining appropriate methodologies.
• Apply mature engineering knowledge to the planning and execution of engineering projects.
• Independently identify when additional internal or external resources are required to resolve technical challenges.
• Manage multiple projects while maintaining appropriate follow-up and completion.
• Delegate and manage project work performed by others.
• 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 large or highly complex system and facility modifications.
• Partner with project managers to complete design and engineering projects within established schedule, budget, and quality requirements.
• Coordinate consultants, architects, and engineering firms in the development of standard design documentation.
• Develop departmental or project budgets involving multiple engineering disciplines.
• Support project cost development and financial analysis activities.
• Provide solutions to a broad range of technical problems involving moderate to large complexity and scope.

Education & Experience

Candidates must meet one of the following:

• Doctorate in Engineering; or
• Master's degree in Engineering plus 2 years of engineering experience; or
• Bachelor's degree in Engineering plus 4 years of engineering experience.

Required Knowledge & Technical Skills

• Working knowledge of pharmaceutical and/or biotechnology processes.
• Familiarity with validation processes and requirements.
• Experience with documentation practices in a highly regulated environment.
• Ability to operate specialized laboratory equipment and computers, as applicable.
• Ability to interpret and apply GLP and GMP requirements.
• Ability to apply engineering principles and scientific knowledge to production environments.
• Understanding of validation protocol execution requirements.
• Knowledge of validation processes and requirements associated with new equipment installations.
• Specialized equipment and/or process expertise.
• Working knowledge of financial analysis tools.

Engineering & Problem-Solving Skills

• Strong problem-solving and applied engineering skills.
• Ability to develop solutions to technical problems of varying complexity.
• Ability to apply scientific and engineering theories, calculations, and creative approaches when developing hypotheses and solutions.
• Ability to independently assess technical issues and determine appropriate approaches.
• Analytical problem-solving skills.
• Ability to manage multiple projects simultaneously.
• Ability to adapt effectively to changing priorities and requirements.
• Schedule development and project coordination.
• Basic project management skills.
• Facilitation and collaboration.
• Negotiation and persuasion.
• Leadership and team building.
• Contractor and vendor management.
• Ability to delegate and oversee project activities.
• Ability to determine when additional resources are needed to address technical or project challenges.

Communication & Professional Skills

• Basic technical report writing.
• Technical presentation skills.
• Strong organizational and personal management skills.
• Ability to interact effectively with individuals with different communication and working styles.
• Ability to facilitate collaboration across multiple functional areas.
• Strong completion and follow-up skills.

Preferred Qualifications

The following experience would make a candidate stand out:

• Commissioning and Qualification (C&Q) experience involving parenteral products.
• Experience with vision systems.
• Experience with device assembly.
• Experience with packaging systems, including automatic and high-mix/low-volume (HMLV) lines.
• Established expertise in at least three separate areas of engineering technology.

Additional responsibilities and functions may be assigned based on business needs.