Lead Automation Project Leader
Responsible for technical leadership of the project software configuration. The Automation Lead Project Engineer co-ordinates the work of the Project engineers on engineering projects. Essential Responsibilities
• Interface with clients to manage requirements
• Resolve technical questions and concerns through interaction with customers, vendors and internal personnel
• Review of detail design (Functional Design Specification & Software Design Specification) documents to ensure alignment with agreed approach and Functional Specifications
• Review of code to ensure quality and requirements are met
• Review of software testing documents from vendor to ensure alignment with agreed approach and FDS/SDS documents
• Witness the execution of the design testing (DT) and configuration testing (CT) and ensure they meet quality guidelines
• Perform documentation updates with the GE quality systems
• Participate in commissioning and qualification activities
Quality
Specific Goals:
1.
Aware of and comply with the GEHC Quality Manual, Quality Management System, Quality Management Policy, Quality Goals, and applicable laws and regulations
as they apply to this job type/position.
2.
Complete all planned Quality & Compliance training within the defined deadlines.
3.
Identify and report any quality or compliance concerns and take immediate corrective action as required.
4.
Support compliance/closure of Regulatory and Quality requirements before completing Design Outputs/Program Deliverables.
5.
Participate in continuous improvement activities by supporting the implementation of process and product quality improvement initiatives.
Requirements:
Qualifications :
• 8+ years of automation experience, preferably in bioprocess manufacturing
• Bachelor's Degree in Chemical Engineering, Electrical Engineering, or related field. Other degrees considered if combined with 5+ years' experience in process equipment project implementation.
• Knowledge of governing regulations, specifically 21CFR211 and Eudralex Volume 4 Annex 11.
• Understanding and experience with cGMP Change Control systems as well as Good Documentation Practices.
• Working knowledge of SDLC (GAMP).
• Strong interpersonal skills, including good technical communication.
• Project management of complex automation projects. Additional Eligibility Qualifications GE will only employ those who are legally authorized to work in the United States for this opening. Any offer of employment is conditioned upon the successful completion of a background investigation and drug screen. Desired Characteristics
• Demonstrated technical leadership capability in integration activities
• Self-starter, energizing, results oriented and able to multi-task
• Excellent teamwork, coordination and communication skills
• Ability to meet aggressive reliability, performance, cost, serviceability, and delivery targets
• Effective oral and written communication skills 7
• Experience with regulated industries (GMP, GAMP)
• Demonstrated hands-on DeltaV experience
• Global project experience
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