Senior Engineer - Process & Packaging Systems

BioPharma Consulting JAD Group

About The Position

The Senior Engineer independently leads and directs process optimization, troubleshooting, and system improvement initiatives across operations, manufacturing, pilot plant, and capital project environments. This role applies advanced and diverse engineering principles to design and implement major system modifications, experiments, and capital projects. The Senior Engineer develops, organizes, analyzes, and presents technical interpretations for operational issues or engineering projects of significant scope and complexity, while providing technical leadership and cross‑functional coordination.

Requirements

Working knowledge of pharmaceutical/biotech processes.
Familiarity with validation processes and documentation in highly regulated environments.
Ability to operate specialized laboratory equipment and computer systems.
Ability to interpret and apply GLPs, GMPs, and engineering science to production.
In‑depth knowledge of validation requirements for new equipment installations.
Expertise in at least three engineering technology areas .
Specialized equipment and process expertise.
Ability to provide solutions to a wide range of technical problems of moderate to large complexity.
Strong analytical problem‑solving skills requiring scientific and engineering theory, calculations, and creative hypothesis development.
Ability to determine when internal or external resources are required to resolve issues.
Ability to manage multiple projects simultaneously.
Experience in schedule development, facilitation, and project follow‑up.
Working knowledge of financial analysis tools and project cost development.
Ability to delegate and manage project work of others.
Experience managing contractors and vendors.
Strong verbal communication and technical report writing.
Effective in technical presentations and cross‑functional collaboration.
Skilled in negotiation, persuasion, conflict resolution, and team‑building.
Ability to work effectively with diverse communication and working styles.
Ability to manage change and drive alignment across teams.
Doctorate OR Master’s + 2 years of engineering experience OR Bachelor’s in Engineering + 4 years of engineering experience

Nice To Haves

Bachelor’s in Mechanical Engineering
Packaging or Materials Science background is a plus
Fully bilingual (English/Spanish)
Familiarity with distribution testing standards: ASTM D4169, ISO, TAPPI, USP, EP .
Strong knowledge of primary and secondary packaging systems and material science used in healthcare packaging.
Understanding of structural packaging components: labels, trays, lidding, leaflets, paperboard, sterile barrier systems, corrugate, etc.
Experience building, modifying, and approving engineering drawings using AutoCAD, Adobe Illustrator, SolidWorks , or similar tools.
Experience writing test protocols, performing technical evaluations, and executing testing to support material and packaging component qualification.
Strong organizational, project management, and technical problem‑solving skills.
Excellent written and verbal communication skills in English and Spanish.
Ability to work independently and lead project teams.
Ability to adapt to evolving environments and collaborate effectively across functions.
Excellent understanding of GMP and GDP .

Responsibilities

Complete complex or novel engineering assignments requiring 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 an ongoing and project basis.
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 with responsibility for determining methodologies in at least one engineering area.
Utilize mature engineering judgment in planning and conducting projects.
Perform additional duties as assigned.
Develop innovative technical solutions to complex problems requiring creativity and strong analytical capability.
Collaborate with Research, Manufacturing, Process Development, Utilities, Facilities, Quality Assurance, and Validation to define requirements for large or highly complex system/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.