Automation Specialist

A career at Resilience is more than just a job – it’s an opportunity to change the future.

Resilience is a technology-focused biomanufacturing company that’s changing the way medicine is made. We’re building a sustainable network of high-tech, end-to-end manufacturing solutions to better withstand disruptive events, serve scientific discovery, and reach those in need. 

For more information, please visit www.resilience.com

JOB SUMMARY:

This job is responsible for providing 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:

• Adheres to cGMPs and applicable Standard Operating Procedures (SOP)

• 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.

• Support planning, detailed design and execution of automation projects.

• Implements modification / change control procedures and protocols.

• Supports Validation department with initial design review, software testing, and protocol review.

• Oversees programming of PLC and HMI application for automated process equipment.

• Oversees maintenance, modifications and updates to automation network and servers.

• Oversees SCADA system, maintenance, backups, and updates.

• Evaluate, facilitate discussions, and respond to technical and documentation inquiries, issues, investigations, and follow-up

• 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:

• Strong knowledge of SCADA applications including historian and batch control servers.

• Strong knowledge of process control systems and automation

• Demonstrated ability to author/review engineering documentation (URS, FS, DS) and Technical Investigations.

• Functional knowledge of engineering documentation required for cGMP process equipment

• Basic PLC and HMI programming skills

• Basic understanding of cGMP software quality system principles

• Working knowledge of word processing, spreadsheet, and database management software

• Basic understanding of 21 CFR Part 11 and Annex 11

• Strong communication skills

PREFERRED QUALIFICATIONS:

• 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

• Understanding of cGMP and sanitary equipment design requirements

• Experience with plant Distributed Control Systems, Historians/Data Collection (iFix, DeltaV, Ignition)

• Experience with GAMP 5 standards and executing FAT/SAT/IQ/OQ protocols

ADDITIONAL REQUIREMENTS:

 Job requires shift work, weekends and occasional extended shifts and possible short notice schedule shift changes

Resilience Biotechnologies Inc. (RESILIENCE), is committed to providing accessible employment practices that are in compliance with the Accessibility for Ontarians with Disabilities Act (AODA). Requests for accommodation can be made at any stage of the recruitment process. Applicants are asked to make their needs/requirements known to Human Resources.

Resilience offers employees a robust total rewards program including an annual cash bonus program, a RRSP/DPSP with a generous company match, a very competitive healthcare, dentalcare, vision care, life, LTD, and AD&D benefits package, fertility healthcare and family-forming benefits, paid vacation, paid holidays, pregnancy and parental leave top-up plan, tuition reimbursement, and employee referral program. Our target base pay hiring range for this position is $75,000.00 - $105,000.00 per year. Actual base pay is dependent upon a number of factors, including but not limited to, the candidate’s geographical location, relevant experience, qualifications, skills and knowledge. Excited about Resilience? We encourage you to apply and start a conversation with one of our recruiters.