Job Description
Job Description
Title: Senior Engineer – Regulated Industry (3536601)
Contract Position with ProQuality Network
Contract Period: Approximately 5 months
Work Schedule: 100% onsite | Administrative shift
Number of Positions: 3
Location: Puerto Rico (open to Puerto Rico residents only)
Position Summary
The Senior Engineer independently leads and/or directs process optimization strategies and troubleshooting of complex operational issues within manufacturing, pilot plant, operations, and capital project environments. This role applies advanced engineering principles to the design, implementation, and execution of major system modifications, experiments, process improvements, and capital projects.
The position requires the ability to develop, organize, analyze, and present data-driven interpretations and solutions for engineering projects of significant scope and complexity in a highly regulated environment.
Preferred Qualifications
- Degree inside Chemical Engineering or Mechanical Engineering (preferred).
- Strong background in GMP-regulated environments, with demonstrated ability to apply GMP principles to manufacturing and validation activities.
- Proven validation expertise, including drafting, executing, reviewing, and approving validation protocols and reports.
- Hands-on experience with time pressure filling systems.
- Experience preparing, reviewing, and approving technical documentation, including protocols, reports, and engineering or validation strategy presentations.
- Demonstrated ability to design and develop protocols for complex systems, such as filling lines and aseptic processes.
- Strong written and verbal communication skills in English and Spanish.
- Proven collaboration with Quality Assurance, Manufacturing, Engineering, and Validation teams during critical project activities.
- Flexibility to support non-standard shifts, including nights, weekends, and extended hours, as required.
Key Responsibilities
General Engineering Functions
- Execute complex or novel engineering assignments requiring the development of new or improved techniques and procedures.
- Develop engineering policies and procedures impacting multiple organizational units.
- Supervise, coordinate, and review the work of engineers, associates, and technicians on both ongoing and project-based assignments.
- Apply advanced and specialized engineering techniques within the area of expertise.
- Utilize engineering principles across disciplines to support a broad range of technical assignments.
- Serve as a recognized technical specialist in at least one engineering area, with responsibility for defining methodologies.
- Plan and conduct projects using mature engineering judgment and technical expertise.
Additional responsibilities may be assigned as business needs evolve.
Design Engineering Responsibilities
- Develop technical solutions to complex problems requiring ingenuity, creativity, and sound engineering judgment.
- Collaborate with Research, Manufacturing, Process Development, Utilities, Facilities, Quality Assurance, and Validation teams to define requirements and recommendations for large or highly complex system and facility modifications.
- Partner with project managers to deliver projects within defined schedule, budget, and quality requirements.
- Coordinate and oversee consultants, architects, and external engineering firms in the development of standard design documentation.
- Develop and manage departmental or project budgets covering multiple disciplines or smaller full-scope projects.
Education Requirements
- 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
Core Competencies & Skills
- Working knowledge of pharmaceutical and biotech manufacturing processes.
- Strong familiarity with validation processes and lifecycle documentation.
- Experience working within highly regulated environments (GMP/GLP).
- Ability to interpret and apply GMPs and GLPs.
- Capability to apply engineering principles to production environments.
- Ability to operate specialized laboratory and production equipment, as applicable.
- Strong problem-solving skills for routine to complex technical challenges.
Demonstrated Skills
- Applied engineering problem-solving and analytical thinking
- Technical report writing and documentation
- Clear verbal and written communication
- Validation protocol writing and execution
- Technical presentations
- Personal organization and time management
- Change management and adaptability
- Equipment- and process-specific technical expertise
- Computer literacy and use of engineering tools
- Independent decision-making regarding internal and external resource needs
- Ability to manage multiple projects simultaneously
Advanced Capabilities
- Schedule development and facilitation
- Cross-functional collaboration
- Basic project management, follow-up, and execution
- Established expertise in at least three engineering technology areas
- Financial analysis and cost development
- Delegation and management of project work
- Leadership, negotiation, conflict resolution, and team building
- Management of contractors, consultants, and vendors
Interested Candidates
This is a contract opportunity with ProQuality Network.
Qualified candidates are encouraged to apply directly through the job description link and submit an updated resume for consideration.
We look forward to reviewing your application.