YOUR TASKS AND RESPONSIBILITIES
Assist in the preparation of comprehensive project proposals including capital, expense, manpower and schedule estimates with a clear map to the long-term business impact.
Lead implementation automated manufacturing technologies. Coordinate collaboration and teamwork between external automation development partners, internal operations staff and subject matter experts (from Sending Unit) to ensure that projects are completed on time, within budget and meeting required quality metrics.
Co-develop and seek approval of User Requirement Specifications for manufacturing, testing and packaging equipment.
Participate in vendor selection process of manufacturing solutions.
Supports development and review of equipment related functional design requirements and specifications as well as participate in factory and site acceptance tests leading to and through successful validation efforts.
Collaborates on development of maintenance procedures and practices with site engineering and maintenance leads.
Collaborate on the development of Process instructions with Process engineering and manufacturing.
Identifies and seek approval for operational improvement efforts aimed at increasing production rate, improving yield, reducing downtime, improving equipment efficiency of transferred processes.
Active participant in the development and completion of Risk analysis and Gap assessment documentation for manufacturing operations, material transfer, analytical methods, mfg.
equipment, computerized systems, and training for assigned products.
Work together with other internal functions and SMEs with the development of validation packages (IQ, OQ, SV, PQ) and Test method validation.
Coordinate execution of said activities and reporting.
Support development of Master Validation pans and pFMEA.
Participate in Technical Transfer Review sessions aimed to obtain approval to start Engineering / technical runs, start of Process performance qualification;
and demonstrate product / process transferred is ready for regulatory submission.
WHO YOU ARE
University Degree in Engineering or similar fields.
Fluent English and Spanish.
At least 4 years of experience developing manufacturing (automated and manual) and packaging (thermoforming, sealing and cartooning) solutions for high-volume operations.
At least 2 years of technical leadership experience.
Knowledge of GxP regulations required.
Digital printing experience (preferred).
Direct experience within Medical Device industries (required).
Experience in Pharma industries, within the Medical Devices industries (preferred)
Experience with automated assembly and packaging of pharma products (preferred)
PLC, Vision system and Robotics experience is preferred.
Experience with precision tube cutting, Solvent and Glue dispensing, as well as bonding and other assembly methods.