Automation Specialist

2 weeks ago

Mississauga, Canada Resilience Full time

COMPANY SUMMARY:
RESILIENCE is creating the first sustainable ecosystem for advanced biopharmaceutical manufacturing. We’re building a robust, dynamic, and diverse network of manufacturing capability and talent - investing in innovation every step of the way.

We provide high-tech, end-to-end manufacturing and development solutions to ensure the medicines of today and tomorrow are accessible to all in need. This includes complex medicines, such as cell and gene therapies, viral vectors, and vaccines; as well as proteins and the next generation of medicines.

RESILIENCE believes in access to quality and innovation for all. Our adaptive facilities serve partners big and small. We continuously invest in R&D for next generation manufacturing and development, freeing our partners to focus on the discoveries that impact lives.

We offer customized and scalable processes, the highest quality and regulatory capabilities, and world-class facilities. Through manufacturing that’s faster, more flexible, and less risky, we safeguard the quality of critical medicines and protect the resilience of a vital supply chain.

JOB SUMMARY:
This job is responsible to provide technical and automation support to manufacturing and facilities operations. This job is also responsible for control of cGMP automation quality systems, software change control, automation configuration management, and automation related corrective actions.

MAJOR RESPONSIBILITIES:

- Provides technical and automation support to manufacturing and facilities operations.
- Prepares periodic evaluation reports for automated systems used in commercial manufacturing.
- Performs investigation of manufacturing deviations and anomalies related to automation and software.
- Implements software changes and upgrades, supports troubleshooting and general diagnostics activities
- Manages small projects related to corrective action or equipment performance improvement as required.
- Implements modification / change control procedures and protocols.
- Supports Validation department with initial design review, software testing, and protocol review.
- Oversees maintenance, modifications and updates to automation network and servers.
- Oversees SCADA system, maintenance, backups, and updates.
- Review, draft, and comment on automation related SOPs, design documentation, FAT, SAT, & IQ/OQ protocols as required.
- Execution of SOPs related to automation.
- Maintenance of PCN network and automation equipment.
- Performs any other job-related duties as assigned.

MINIMUM QUALIFICATIONS:
TECHNICAL KNOWLEDGE / EXPERIENCE:

- Requires BS/BA in Science, Engineering or Software Programming
- Minimum 3-5 years direct experience programming, designing and/or maintaining industrial control systems in a pharmaceutical or biopharmaceutical industry
- Basic understanding of cGMP and sanitary equipment design requirements
- Strong knowledge of process control systems and automation
- Functional knowledge of engineering documentation required for cGMP process equipment
- Strong PLC and HMI programming skills
- Basic understanding of cGMP software quality system principles
- Working knowledge of word processing, spreadsheet, and database management software
- Strong communication skills

EQUIPMENT:

- PLC and PC computers, electrical test equipment, and software programming tools

ADDITIONAL REQUIREMENTS:

- Pre-employment medical and medical re-examination performed every 2 years or as per RESILIENCE’s SOPs
- Included as part of the medical is a respirator fit test (half mask), and pulmonary function test

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