GMP Senior Engineer (Electrical and Mechanical Engineer) jobs in United States
cer-icon
Apply on Employer Site
company-logo

Grifols · 18 hours ago

GMP Senior Engineer (Electrical and Mechanical Engineer)

Grifols is a global healthcare company that has been working to improve the health and well-being of people around the world since 1909. They are seeking a Senior Engineer to provide technical leadership and support for diagnostics manufacturing operations, focusing on mechanical design, electrical systems, and reliability engineering. The role involves leading cross-functional engineering projects and ensuring the performance and compliance of production equipment.

BiotechnologyHealth CareManufacturing
check
H1B Sponsor Likelynote

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)

Qualification

Mechanical EngineeringElectrical EngineeringGMP ComplianceSolidworksAutoCad ElectricalReliability EngineeringProject ManagementTroubleshooting SkillsData Integrity Knowledge3D Printing KnowledgeCross-Functional LeadershipMentoring Skills

Required

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
Direct experience working in regulated environments (i.e. cGMP, OSHA, ISO) required
Ability to design and develop Mechanical solutions and prototypes using Solidworks
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)

Preferred

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

Benefits

Medical
Dental
Vision
PTO
Up to 5% 401(K) match
Tuition reimbursement

Company

Grifols is a global healthcare company.

H1B Sponsorship

Grifols has a track record of offering H1B sponsorships. Please note that this does not guarantee sponsorship for this specific role. Below presents additional info for your reference. (Data Powered by US Department of Labor)
Distribution of Different Job Fields Receiving Sponsorship
Represents job field similar to this job
Trends of Total Sponsorships
2025 (2)
2023 (2)
2022 (1)
2020 (2)

Funding

Current Stage
Public Company
Total Funding
$2.51B
Key Investors
Michael J. Fox Foundation
2025-01-14Grant· $21M
2024-06-04Post Ipo Debt· $1.41B
2024-04-23Post Ipo Debt· $1.07B

Leadership Team

leader-logo
Camille Alpi
Chief Human Resources Officer
linkedin
leader-logo
Víctor Deu
Director of Planning & Control Department
Company data provided by crunchbase