Senior Process & Systems Engineer

BioPharma Consulting JAD Group

13h

About The Position

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.

Requirements

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.

Nice To Haves

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.

Responsibilities

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.