The Senior Process & Systems Engineer independently leads and directs process optimization initiatives and the troubleshooting of operational issues across manufacturing, operations, pilot plant, and capital project environments. This role applies advanced and diverse engineering principles to design and implement major system modifications, experiments, and engineering solutions. The engineer develops, organizes, analyzes, and presents technical interpretations for projects of significant scope and complexity, ensuring alignment with operational, quality, and regulatory expectations.
FUNCTIONS
- Execute complex or novel engineering assignments requiring the development of new or improved engineering techniques and procedures.
- Develop engineering policies and procedures that impact multiple organizational units.
- Supervise, coordinate, and review the work of engineers, associates, and technicians on both ongoing and project‑specific bases.
- Apply advanced engineering techniques and adapt specialized methods within area of expertise.
- Apply engineering principles outside primary discipline to support a broad range of assignments.
- Serve as a peer‑recognized technical specialist responsible for determining methodologies in at least one engineering area.
- Utilize mature engineering judgment in planning and executing projects.
- Perform additional duties as assigned.
- Develop technical solutions to complex problems requiring creativity, innovation, and engineering theory.
- Collaborate with Research, Manufacturing, Process Development, Utilities, Facilities, Quality Assurance, and Validation to define requirements and recommendations for large or highly complex system or facility modifications.
- Partner with Project Managers to deliver engineering and design projects within scope, schedule, budget, and quality expectations.
- Coordinate work with consultants, architects, and engineering firms to develop standard design documentation.
- Develop departmental or project budgets involving multiple engineering disciplines.
SKILLS
- Working knowledge of pharmaceutical/biotech processes.
- Familiarity with validation processes and protocol execution requirements.
- Experience with documentation in highly regulated environments.
- Ability to operate specialized laboratory equipment and computer systems.
- Ability to interpret and apply GLP/GMP requirements.
- Ability to apply engineering science to production systems.
- Ability to develop solutions to routine technical problems of limited scope.
- Strong problem‑solving and applied engineering skills.
- Technical report writing and verbal communication skills.
- Expertise in validation processes for new equipment installations.
- Ability to manage multiple projects simultaneously.
- Strong analytical problem‑solving and engineering calculation skills.
- Ability to determine when internal or external resources are required to resolve issues.
- Experience with schedule development, facilitation, and cross‑functional collaboration.
- Basic project management, completion, and follow‑up skills.
- Established expertise in at least three engineering technology areas.
- Working knowledge of financial analysis tools and project cost development.
- Ability to delegate and manage project work of others.
- Strong negotiation, persuasion, conflict resolution, leadership, and team‑building skills.
- Ability to interact effectively with diverse communication and working styles.
Requirements
EDUCATION & EXPERIENCE REQUIREMENTS
- Doctorate OR
- Master’s degree + 2 years of engineering experience OR
- Bachelor’s degree in Engineering + 4 years of engineering experience.
PREFERRED QUALIFICATIONS
- Bachelor’s degree in Mechanical, Electrical, or Industrial Engineering with 4+ years of engineering experience.
- Experience supporting biotechnology or pharmaceutical process operations, particularly Drug Substance processes.
- Knowledge of GMP pharmaceutical manufacturing systems.
- Experience with SAP, TrackWise, electronic batch records (PAS/X), and document management systems (Veeva).
- Experience with automated and manual inspection equipment.
- Technical knowledge of inspection technologies for parenteral and glass containers.
- Experience applying engineering principles to improve equipment reliability and performance.
- Ability to direct technical resources such as Mechanics, Automation Technicians, and IS teams.
- Experience supporting complex system or facility modifications across multiple business functions.
- Strong technical writing and verbal communication skills in English and Spanish.
- Strong organizational, presentation, and change‑management capabilities.
Benefits
- 1-year contract
- Administrative Shift
Skills Required
- Doctorate OR Master's degree plus 2 years engineering experience OR Bachelor's degree plus 4 years engineering experience
- Working knowledge of pharmaceutical/biotech processes
- Familiarity with validation processes and protocol execution requirements
- Experience with documentation in highly regulated environments
- Ability to interpret and apply GLP/GMP requirements
- Expertise in validation processes for new equipment installations
- Established expertise in at least three engineering technology areas
- Ability to supervise, coordinate, and review work of engineers, associates, and technicians
- Strong problem-solving and engineering calculation skills
- Ability to manage multiple projects simultaneously and basic project management skills
- Experience with SAP, TrackWise, PAS/X, and Veeva (document management/electronic batch records)
- Experience supporting biotechnology or pharmaceutical process operations, particularly Drug Substance processes
- Strong technical writing and verbal communication skills in English and Spanish
What We Do
BioPharma Consulting JAD Group provides a complete portfolio of technical support and solutions for the FDA regulated industry. We deliver solutions with a flexible cost effective approach to meet your company’s needs. BPC JAD group is a company created to help our customers bridge the gap between their business strategy and results. Our mission is to help our clients succeed by partnering with them and providing value added business solutions on the validation, engineering and compliance fields. We will carry out our mission by creating a long-term partnership with our customers and provide reliable and cost effective technical solutions. BPC JAD Group objective is to deliver reliable tailored solutions; from providing consultation to becoming part of your staff. We will develop customized frameworks to help our customers unlock the hidden value in their plants, facilities, equipment and people with an optimal integration of resources regulations and technology.
