GMP Senior Engineer (Electrical and Mechanical Engineer)

GRIFOLS, S.A.•San Diego, CA

31d•$112,388 - $140,486•Onsite

About The Position

Would you like to join an international team working to improve the future of healthcare? Do you want to enhance the lives of millions of people? Grifols is a global healthcare company that since 1909 has been working to improve the health and well-being of people around the world. We are leaders in plasma-derived medicines and transfusion medicine and develop, produce and market innovative medicines, solutions and services in more than 110 countries and regions. Grifols Diagnostic Solutions Inc is seeking a Senior Engineer in San Diego, CA. This position is a key member of the Manufacturing Technical Support team responsible for technical leadership and direct support for diagnostics manufacturing operations. This role integrates expertise in mechanical design, electrical systems, reliability engineering, and industrial automation to ensure the performance, compliance, and reliability of our production equipment. The ideal candidate will play a key role in supporting the manufacture of high-quality diagnostic products that impact global health. Leads / manages cross-functional engineering projects for implementation of new capital investments (engineering design, start-up and qualification of GMP process equipment). Assures continuous improvement of automated Filling, Labeling, Packaging, Oligosynthesis, Bulk equipment and processes. We are seeking individuals with at least a Bachelors in Mechanical or Electrical Engineering, or related field. Along with 7 years of related industry experience and at least 1 year of experience in pharmaceutical/biotech operations, with thorough working knowledge production unit operations and validation principles.

Requirements

Direct experience working in regulated environments (i.e. cGMP, OSHA, ISO) required.
Ability to design and develop Mechanical solutions and prototypes using Solidworks. 3D model design and 2D drawings of mechanical parts and assemblies, following the required regulations, good practices and industry standards.
Ability to design and develop Electrical solutions for improving the equipment, using AutoCad electrical to create and update electrical drawings following the required regulations, good practices and industry standards.
Fast learner with proven capability to quickly adapt to new technologies and systems.
Working knowledge of fully automated liquid filing and labeling equipment.
Strong troubleshooting skills across a wide range of equipment and systems.
Capable of working independently, assessing situations to determine when to request support.
Highly motivated self-starter with the ability to take initiative and drive tasks to completion.
Demonstrated success in leading cross-functional engineering projects.
Knowledge of data integrity (ALCOA+), Industry 4.0, and smart factory technologies.
Knowledge of computerized maintenance management systems (SAP, Maximo).
BS Mechanical or Electrical Engineering, or related field.
Minimum 7 years related industry experience required.
1+ year experience in pharmaceutical/biotech operations, with thorough working knowledge production unit operations and validation principles.

Nice To Haves

Experience with in-line printing systems (Novexx, Zebra) and automated label application equipment is preferred.
Experience with oligosynthesis, HPLC instrumentation and RO/DI purified water systems is preferred.
3D printing knowledge is preferred
Ability to troubleshoot PLC/HMI systems (Allen Bradley), Vision systems (Cognex, Keyence) and Robotics (Staubli) is preferred.
Experience with materials selection and analysis for plastics, glass, and stainless steel is preferred.

Responsibilities

Completion of design and engineering projects within schedule, budget and quality requirements.
Analyze reliability data and Implement equipment and process improvement projects to improve equipment up-time and Overall Equipment Effectiveness (OEE)
Ability to evaluate legacy equipment/systems and propose improvements to cycle time, quality compliance, data integrity.
Lead mechanical and electrical design improvements for custom manufacturing equipment including Filling, Labeling, Packaging equipment.
Experience leading project design, FAT, SAT, start-up, commissioning and qualification of new equipment and utilities.
Support root cause investigations for quality events and reliability issues. Perform technical assessments for process and equipment issues, driving preventive actions. Offer long term solutions to identified problems.
Support project teams focused on technology transfer, introduction of new products or processes, process improvements. Provide feasibility assessments and process and equipment requirements.
Employ advanced engineering principles within area of engineering expertise; ability to apply knowledge of engineering principles and practices outside of area of discipline expertise.
Develop technical solutions to complex problems requiring the regular use of ingenuity and creativity. Propose improvements and different approaches to solve problems
Perform PFMECA and reliability modeling to support risk-based decision-making.
Mentor junior engineers and mechanics, fostering a culture of technical excellence and innovation.
Documentation and creation of guides, processes and methods for the Engineering team.
After hours and shift support may be required. (On-Call)