Sr Automation Engineer – Pack, Serialization, VI

WHY PATIENTS NEED YOU

Whether you are involved in the design and development of manufacturing processes for products or supporting maintenance and reliability, engineering is vital to making sure customers and patients have the medicines they need, when they need them. Working with our innovative engineering team, you'll help bring medicines to the world even faster by imagining what’s possible and taking action.

ROLE SUMMARY

The Sr Automation Engineer – Pack, Serialization, VI will have overall responsibility for managing regulatory aspects of the process automation and control systems used in the manufacture of sterile injectable.  This position will provide engineering and technical support related to the operation, maintenance, installation, startup/commissioning, testing, and qualification of pack lines, serialization and visual inspection systems within a sterile injectable manufacturing facility.

ROLE RESPONSIBILITIES

• Support the operation and troubleshooting of manufacturing equipment and control systems
• Support reliability engineering for production and support equipment
• Provide on the floor operational support as needed
• Support all investigations and audits as needed
• Provide off-shift and on call support when necessary
• Responsible for Periodic review of the Automation Systems
• Responsible for assuring various user levels have appropriate, documented training and authorization for access to engineering managed computer systems
• Responsibility for managing regulatory aspects of the sites networked engineering data collection, monitoring and SCADA systems
• Responsible for implementation of compliance initiatives including monitoring of system security procedures and practices, review of audit trails and system logins for compliance
• Design and implementation support for minor functional and process changes, either smaller projects, remediation activities or capital projects
• Support future capital projects and assure site automation standards are followed
• Assist other departments in evaluating historical process/equipment data
• Provide automation guidance and training to other functional groups (ie. Operations, Validation, Maintenance, etc)
• Author and/or review design documents for projects and process changes
• Support FAT/commissioning/qualification activities as required
• Responsible for backup/archiving/restoring of Automation configuration and batch
• Develop and implement site automation standards for hardware and software
• Develop automation Standard Operating Procedures
• System Admin for all site SCADA systems, Data Historians, and Engineering Site–wide Software Applications
• System Administration for adding and disabling user access to Site Automation system
• Maintain Manufacturing level network, control level networks and Process I/O network.

QUALIFICATIONS

Must-Have

• Bachelor’s degree in Engineering (Chemical, Computer, Mechanical or Electrical)
• 3+ years of demonstrated experience in Automation Engineering
• Experience with writing software test plans, user requirements, and system design documents
• Hands on experience with Systech Vision System / TIPS, OPTEL Vision System / Serialization – LineMaster, PharmaProof, OSM Server.
• Familiar with process controls equipment
• Strong knowledge of Computerized Systems, Compliance regulations and standards
• Teamwork spirit, good communication skills and training abilities
• Excellent interpersonal effectiveness and communication skills {written and oral}

Nice-to-Have

• Master's degree
• Relevant pharmaceutical experience
• Understanding of programming, and proficiency in at least one language
• Physical or Mental Requirements

PHYSICAL/MENTAL REQUIREMENTS

PHYSICAL/MENTAL REQUIREMENTS

Lifting, sitting, standing, walking, bending, ability to perform mathematical calculations and complex data analysis, problem solving.  Ability to work in a gown room conditions.  Ability to write general correspondence and technical reports.  Requires good written, oral communication and presentation skills. Requires good planning, organizing, time management and team participation skills.

• Non Standard Work Schedule, Travel or Environment Requirements

NON-STANDARD WORK SCHEDULE, TRAVEL OR ENVIRONMENT REQUIREMENTS

NON-STANDARD WORK SCHEDULE, TRAVEL OR ENVIRONMENT REQUIREMENTS

Regular Work Schedule:

• Sta