Job Posting Date
Mar 13, 2018, 9 : 52 : 55 AM SUMMARY OF ROLE This role supports life sciences project team with specific focus on managing project lifecycle documentation for an automation / controls system project.
Produce or coordinates the generation of quality assurance plans, verification plans, validation plans, and standard operating procedures as well as conduct risks assessments and participate in Quality / Regulatory audits.
Develops and executes qualification protocols and final summary reports and may participate in commissioning activities at Customer’s sites.
All CSV related regulatory requirements must be fulfilled during the complete life cycle (planning, design, procurement, construction, commissioning and control system qualification).
REPORTS TO : Systems Project Execution Manager SPECIFIC JOB RESPONSIBILITIES
Lead Quality & Compliance daily activities with regard to project execution against the acceptable GMP and applicable ISO Standards
Be part of engineering teams and interact with other groups for the introduction of new systems and processes. To give advice and support for the preparation of CSV related activities and guard the cGMP aspects in new projects.
Be a member of cross-functional teams to realize cross-departmental objectives
Follow-up audit action plan proposal and progress
Produce Review and approve CSV documents such as SOPs, user requirements, impact / risks analysis’s, Validation Plans, tests, etc ) in order to maintain compliance to regulations, guidelines, customers policies and standards.
Manage quality issues : review of deviations, out of specifications, non-conformances and other critical issues; investigation review, follow up on resulting action plans
Evaluate the incidents related to CS and propose corrective actions if necessary. Identify possible impact on the product quality and pass the incident to QA focus if this is the case.
Follow-up activities related to CSV resulting from (internal and external) audits, quality system initiatives (FIR, CAPA, QIP, ).
Collect change control related information, evaluate proposed changes, evaluate project and quality documentation, assess validation protocols and reports testing
Collect and review Product Quality Reviews, follow up on resulting action plan
Regularly communicate status & results to project execution team
Document Controller activity on small projects, support to nominated Document Controller for medium / large projects.
Site support during validation
Impact assessment and validation strategy for service team
Train internal resources and suppliers (GMP, data integrity, CSV, etc.) REQUIRED QUALIFICATIONS AND EXPERIENCE
Engineering degree, state-certified technician, completed vocational training or equivalent knowledge
5+ years of Computer System Validation (CSV) experience with process control, SCADA and automation systems, MES and data integration systems (Emerson DeltaV and / or Syncade experience is highly preferred)
Experience with automation, commissioning, qualification or operations in a cGMP environment.
Direct experience developing validation protocols and execution of protocols.
Knowledge of GAMP’s : generic and specific (Global Information Systems, IT Infrastructure Control and Compliance, A Risk-
Based Approach to Compliant Electronic Records and Signatures, Validation of Laboratory Computerized Systems, Testing of GXP System, ).
Knowledge of SW development and testing processes.
Knowledge of Quality auditing
Knowledge of Software quality metrics
Capacity to 'translate’ technical information into information that can be understood at every level of the organization.
Being able to correctly estimate the urgency, criticality and impact of decisions related to the function.
Ability to multi-task and work on a variety of projects at one time.
Ability to work independently and work in cross-functional team environment.
Excellent client communication skills.
Be fluent in written and spoken Italian and English.
CORE COMPETENCIES Getting Things DoneInnovation / Improvement
Interpersonal / Communication Skills
Ethics / Integrity Employee Referral - this role is eligible at this time. About Emerson
Imagine being surrounded by intelligent, driven, and passionate innovators all working toward the same goal to create groundbreaking solutions that leave our world in a better place than we found it.
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Our Emerson Automation Solutions business helps process, hybrid, and discrete manufacturers maximize production, protect personnel and the environment while optimizing their energy and operating costs.
Our Emerson Commercial and Residential Solutions business helps ensure human comfort and health, protect food quality and safety, advance energy efficiency, and create sustainable infrastructure.
A dynamic environment is what you’ll discover at Emerson, a Fortune 500 company with $14.5 billion in sales and 155 manufacturing locations worldwide.
Together, we’re changing the world, and we have all the resources to help you achieve your professional goals.
Whether you’re an established professional looking for a career change, an undergraduate student exploring options, or recently received your MBA degree, you’ll find a variety of opportunities at Emerson.
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