Process Engineering Automation Specialist
About OmniaBio:
OmniaBio Inc. is a subsidiary of Toronto-based CCRM (ccrm.ca), a leader in developing and commercializing regenerative medicine-based technologies and cell and gene therapies. OmniaBio’s facility will be Canada’s first commercial-scale contract development and manufacturing organization (CDMO) dedicated to cell and gene therapies and is expected to be the largest facility of its kind in Canada.
Based at McMaster Innovation Park in Hamilton, Ontario, OmniaBio will anchor a biomanufacturing centre of excellence and open in three phases between 2024 and 2026. OmniaBio has built a substantial team and continues to grow to prepare for this expansion. Benefitting from CCRM’s existing expertise and business practices, OmniaBio currently has established process and analytical development teams and contract manufacturing capabilities. OmniaBio is built upon leadership in induced pluripotent stem cells (iPSCs), immunotherapy and lentiviral vectors (LVVs). The vision is to provide focused support for clients with late clinical-stage manufacturing and commercial supply needs, in addition to early-stage development and first in-human clinical trial material services. Please visit us at omniabio.comto learn more.
Role Summary:
This position is responsible to provide technical and automation support to manufacturing and facilities operations. The Process Engineering Automation Specialist is responsible for the control of cGMP automation quality systems, software change control, automation configuration management, and automation related investigations and corrective actions.
Responsibilities:
- Provides technical and automation support to laboratory, manufacturing and facilities operations.
- Prepares periodic evaluation reports for automated systems used in late phase clinical/commercial manufacturing.
- Performs investigation of manufacturing deviations related to automation and software. Oversees the definition and implementation of Corrective Action.
- Implements software changes and upgrades, supports troubleshooting and general diagnostics activities.
- Manages small projects related to corrective action or equipment performance improvement as required.
- Automation SME for major CapEx 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.
- 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 related duties as assigned.
Requirements:
- Knowledge / Experience
- Requires BS/BA in Science, Engineering or Software Programming.
- Minimum 4 years direct experience programming, designing and/or maintaining industrial control systems in a pharmaceutical or biopharmaceutical industry.
- Good 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.
- A solid knowledge of Historian and SCADA applications.
- Understanding of cGMP software quality system principles.
- Working knowledge of word processing, spreadsheet, and database management software.
- Behaviours:
- Good analytical and problem-solving skills.
- Ability to articulate technical understanding to non-Automation SMEs.
- Compliance mind-set.
- Ability to respond to urgent situations.
- Tenacious.
OmniaBio Inc. is a developing organization and represents a fluid working environment. Flexibility and adaptability are essential, and duties will be influenced by the needs of the organization.
Applicants must be legally eligible to work in Canada.
OmniaBio Inc. is committed to accessibility, diversity, and equal opportunity. Requests for accommodation can be made at any stage of the recruitment process, providing the applicant has met the bona fide requirements for the open position. Applicants should make their requirements known once contacted to schedule an interview, or when the job offer has been made.
Other details
- Pay Type Salary
- Canada