Senior Engineer
BioPharma Consulting JAD Group View all jobs
- Juncos, PR
- Contract
- Full-time
- Lead complex and novel assignments requiring development of new or improved engineering techniques and procedures.
- Develop and implement engineering policies and procedures impacting multiple functional areas.
- Supervise, coordinate, and review the work of engineers, associates, and technicians.
- Apply advanced and cross-disciplinary engineering principles to solve complex problems.
- Serve as a recognized subject matter expert (SME) in a specialized technical area.
- Plan and execute engineering projects using sound technical judgment and methodologies.
- Lead characterization studies and process optimization initiatives.
- Troubleshoot operational issues in manufacturing, pilot plant, and production environments.
- Develop innovative solutions using data analysis, engineering theory, and experimentation.
- Interpret and present complex technical data to support decision-making.
- Develop technical solutions for complex system and facility challenges requiring creativity and ingenuity.
- Collaborate with cross-functional teams (Manufacturing, Process Development, Quality, Validation, Facilities, Utilities).
- Define requirements and provide recommendations for large-scale system or facility modifications.
- Support execution of capital projects within scope, schedule, budget, and quality constraints.
- Coordinate external consultants, contractors, architects, and engineering firms.
- Develop and manage project budgets across multiple disciplines.
- Support and ensure compliance with validation processes (IQ/OQ/PQ).
- Contribute to validation protocol development and execution.
- Ensure adherence to GMP, GLP, and regulatory requirements.
- Maintain and review technical documentation in a regulated environment.
- Lead cross-functional teams and engineering initiatives.
- Manage multiple projects simultaneously, ensuring timely delivery.
- Delegate tasks and oversee execution of project deliverables.
- Manage contractors, vendors, and external resources.
- Support financial planning, cost estimation, and project tracking.
- Strong knowledge of pharmaceutical/biotech manufacturing processes.
- Working knowledge of validation lifecycle (IQ/OQ/PQ).
- Familiarity with GMP/GLP regulations and documentation practices.
- Advanced problem-solving and analytical engineering skills.
- Ability to apply engineering principles to production environments.
- Strong technical writing, reporting, and presentation skills.
- Effective verbal communication and cross-functional collaboration.
- Ability to manage multiple projects and priorities simultaneously.
- Proficiency in standard computer and engineering tools.
- Doctorate degree, OR
- Master's degree + 2 years of Engineering experience, OR
- Bachelor's degree in Engineering + 4 years of Engineering experience
- Degree in Mechanical or Chemical Engineering.
- Experience in aseptic manufacturing environments.
- Hands-on experience with Fill/Finish operations (vial and syringe filling lines).
- Experience supporting:
- Process characterization studies
- Performance Qualification (PQ) activities
- New Product Introductions (NPI)
- Strong experience in capital projects, system design, and equipment installation.
- Demonstrated ability to lead complex engineering projects in regulated environments.
- Experience coordinating contractors, vendors, and multidisciplinary teams.
- Administrative Shift & Non-Standard Shift (night shift and/or 12 hours shifts)
- 8-month contract