Senior Engineer - Packaging

BioPharma Consulting JAD Group

2d•Onsite

About The Position

We are seeking a Senior Engineer - Packaging to support packaging and final product manufacturing operations at a biopharmaceutical manufacturing site in Juncos, Puerto Rico. This role independently provides and directs process optimization strategies and troubleshooting of operational issues in operations, manufacturing, pilot plant or capital project environments, applying advanced engineering principles to the design and implementation of major system modifications, experiments, process and capital projects.

Requirements

Doctorate degree; OR Master's degree + 2 years of engineering experience; OR Bachelor's degree in Engineering + 4 years of engineering experience
Working knowledge of pharmaceutical/biotech processes and validation (protocol writing and execution, new equipment installations)
Documentation in a highly regulated environment; ability to interpret and apply GMPs/GLPs
Strong interpersonal, project management, technical problem-solving and written/verbal communication skills
Schedule development, project cost development and working knowledge of financial analysis tools
Leadership, team building, negotiation, conflict resolution and management of contractors and vendors
Ability to handle multiple projects and adapt to a continuously evolving environment

Nice To Haves

Packaging/engineering experience in final product manufacturing within the pharmaceutical/biotech industry
Excellent understanding of Good Manufacturing Practices (GMP) and Good Documentation Practices (GDP)
Strong knowledge of primary and secondary packaging materials (bottles, labels, trays, lidding material, leaflets, paperboard, sterile barrier packaging, corrugate, etc.)
Familiarity with distribution testing per ASTM D4169 and ASTM, ISO, TAPPI, USP and EP testing standards
Experience writing test protocols, performing technical evaluations and testing to support material/component selection reports

Responsibilities

Complete complex or novel assignments requiring the development of new or improved engineering techniques and procedures.
Develop engineering policies and procedures that affect multiple organizational units.
Supervise, coordinate and review the work of a small team of engineers, associates and/or technicians on an ongoing and project basis.
Serve as a peer-recognized technology specialist, responsible for determining methodologies in your area of expertise.
Develop technical solutions to complex problems requiring ingenuity and creativity.
Partner with manufacturing, process development, utilities, facilities, quality assurance and validation to define requirements and recommendations for large or highly complex system/facility modifications.
Work with project managers to complete design and engineering projects within schedule, budget and quality constraints.
Coordinate the work of consultants, architects and engineering firms on standard design documents.
Develop project budgets encompassing multiple disciplines.
Write test protocols and perform technical evaluations and testing to support reports justifying selected packaging materials and components.
Develop, organize, analyze and present results for engineering projects of significant scope and complexity.