- 07-Jan-2014 to 05-Feb-2014 (CST)
- Facility Engineering
- College Station, TX, USA
- Full Time
Summary: The Associate Director of Automation will be responsible for all aspects of automation (excluding IT specifically) including support computer system and controls validation activities for Kalon Biotherapeutics. Note automation covers utility and process automation.
• Support validation as Subject Matter Expert to ensure that appropriate regulations (e.g. 21 CFR Part 11 and cGMP) are addressed in validation in a development phase and level appropriate manner.
• Interfaces with IT to ensure GMP compliant integration with Corporate IT infrastructure
• Interact with design team on automation architecture and functionality.
• Draft, review and approve local validation and compliance documents supporting GxP computerized systems and relevant infrastructure, including those related to system procurement, audit, performance, compliance evaluation, and validation. Examples include SOPs, qualification protocols, gap assessments, risk assessments, impact assessments, user requirements, functional and configuration specifications, requirements traceability, validation plans, validation summary reports and change controls.
• Prepare, assist, and participate in system design, specification development, and design review.
• Prepare and track automation budgets.
• Must be able to function independently, play a leadership role within a cross-functional team and address a variety of moderate to complex problems.
• Assess the impact of system changes through change management and change control systems and participate in the planning and implementation of change.
• Provide training to colleagues and contractors on our approach to automated systems.
• Support Manufacturing, Facilities Engineering and Engineering management on BMS, SCADA, GMP controls, Utility Controls, Process Equipment PLC's, GMP data archiving and retrieval.
• Act as SME for automation changes.
• Recruit, train and direct junior automation engineers
• Maintain FS documents for automation of HVAC and automation systems.
• Work with MFG on FS for automated process equipment.
• Assist validation activities of cross functional teams that include technical functions such as Information Systems, Manufacturing and Quality Assurance Engineering.
• Develop and maintain Automation SOPs, forms, documentation and files.
• Coordinate meetings and document issues, action items, meeting notes including performance of appropriate follow up related to Control Systems Validation projects.
• Perform Engineering Test Plans for automation
• Execute Software Test Specification
• Maintain backups of automation code.
Required Skills & Abilities:
• BMS design, commissioning and validation in a GMP facility required.
• Experience in thorough testing of applications, computerized systems, changes and implementations.
• Experience with SCADA design, implementation and operation required.
• Data archiving and retrieval required.
• Experience with FDA/EU GMP inspection required
• Experience with critical utility and non-GMP utility systems a plus.
• Knowledge of interfacing with Metrology on automated systems required.
• Familiarity with GAMP and other approaches to System Development Life Cycles (SDLC), CAPA.
• Computer knowledge of 21 CFR Part 11.
• Excellent written and oral communication skills.
• Must be customer service oriented.
• FDA Compliance experience required.
• Must be able to apply complex system validation principles to work assignments.
• Experience with DCS systems such as Delta V, etc. preferred
• Able to operate in an optimized budgetary environment
Working Conditions & Physical Requirements:
The physical demands described here are representative of those that must be met by an employee to successfully perform the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions. While performing the duties of this job, the employee is regularly required to:
• Experience prolonged standing, some bending, stooping, and stretching.
• Use hand-eye coordination and manual dexterity sufficient to operate a keyboard, photocopier, telephone, calculator, and other office equipment is required
• Have a normal range of hearing and vision.
• Undergraduate degree in a technical field required.
• At least 10 years of experience with automated systems in a GMP setting.
• Must have a thorough understanding of FDA regulations and computer validation guidance documents.
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