Prospanica 2016 Process Engineer Marietta PA

Job description

Details:

Why GSK? Because GSK's vaccines business puts the customer at the heart of everything we do. That's why we define our vaccines mission as: Protecting • Human • Kind. Protecting because we strive to turn the science of immunology into high-quality, practical protection against disease; Human because we are investing time in understanding and delivering on our customers' needs and helping them achieve their vaccination goals; and Kind because we recognize and act on our responsibilities to serve societies, rich and poor.
The Process Engineer provides technical support for the Marietta site's Formulation, Filling and Lyophilization Value Stream as a member of the FFL engineering / technical operations group.
In this role, you would maintain, troubleshoot, and optimize performance for the related solution preparation, sterilization, vial handling, lyophilization and inspection equipment and controls within the Aseptic Process / Sterile Fill environment. Advocates safety, quality, reliability and production efficiency.

Key Responsibilities:
•Work with other engineering subject matter experts, provide input and make recommendations on the design, installation and commissioning of electro mechanical equipment, processes and controls for the FFL operations. Ensure harmonization with GSK standards.
•Recommend and provide guidance in the development and optimization of training materials and maintenance procedures intended to deliver high reliability for the aseptic processing / sterile fill production environment.
•Gain proficiency and routinely utilize process diagnostic, SCADA, CMMS and related system tools to support troubleshooting, Identify process improvements, evaluate trends and drive process reliability.
•Serve as department technical representative on project, deviation assessment, safety and process improvement teams.
•Support Quality Management Systems through root cause analysis, CAPA and change control process execution. Participate and lead assigned technical investigations through to full closure while implementing appropriate resolutions.
•Provide technical guidance to electro-mechanical technicians with focus on plc and control systems.
•Build effective relationships and work cross functionally to engage other groups such as Facilities, Quality Assurance, EHS, Automation, Validation, etc to help ensure a cohesive support model for the FFL Operations.
•Manage vendors and consultants in accordance with GSK policies and ensure alignment on the agreed contract deliverables, documentation and process equipment performance.
•Provide technical expertise for regulatory, compliance and safety audits.

Additional Skills:
•Good verbal, written and interpersonal communication skills are essential. Ability to draft and execute engineering and validation protocols.
•Ability to technically interact with local technicians, engineers and global equipment vendors and effectively troubleshoot related mechanical, plc and control systems.
•Basic knowledge of related facility systems and their link to the operational process.
•Ability to execute work per required cGMP and GSK standards such as SOPs and protocols with adherence to required training.
•Demonstrate a serious commitment to safety, quality and accuracy while meeting goals or deadlines.
•Must be a committed team player prepared to work in and embrace a team based culture. Works closely with all shifts to achieve goals in a 24/7 cGMP production environment. This schedule may include holidays, weekends and over-time.
•Demonstrate ability to perform all job duties with limited supervision in a matrix environment.
•Maintain a high level of integrity and confidentiality while balancing multiple priorities and responsibilities.
•Perform all job responsibilities in compliance with applicable regulations, standard operating procedures, and industry practice.

"LI-GSK

Contact information:

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Desired profile

Basic qualifications:

BS Degree in engineering (Process and equipment mechanical & controls technical support)
minimum one year applicable industrial experience within the pharma/ biotech industry
•PLC ( Programmable Logic Controller ) or Process industrial troubleshooting
•Minimum one year experience with Allen Bradley, SCADA
•Prior project engineering or project management, exposure to production operations
•Physical requirements include stooping, standing, climbing and occasional lifting of a minimum of 20 lbs. of equipment
•Ability to use & produce P&ID's, logic diagrams and related engineering data for troubleshooting and change documentation.
Must be able to achieve appropriate certification within 6 months of hire and work in environment which includes wearing full protective gowning that is required for GMP areas.

Preferred qualifications:

BS in Mechanical, Chemical, Process Controls Engineering• 3 or more years in pharmaceutical production environment
•Validation – ability to write and execute protocols
•Design and programming with DCS, SCADA and/or PLCs.
•Working knowledge of cGMPs and 21 CFR part 11.