Automation Specialist
1 week ago
**Job Title**:
Automation Specialist
**Revision No.**:
OBAUTOSPEC-20241212
**Department**:
Engineering & Facilities
**Working Arrangement**:
On Site
**About OmniaBio**
OmniaBio Inc. is a subsidiary of Toronto-based CCRM, a leader in developing and commercializing regenerative medicine-based technologies and cell and gene therapies. Visit CCRM at ccrm.ca. 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.
**Position Summary**
This position is responsible to support technical and automation activities for manufacturing and facilities operations. The Automation Specialist supports control of cGMP automation quality systems, software change control, user management, backup and recovery, audit trail reviews, 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.
- Set up and manage user management, back ups and recovery for non networked systems.
- Perform periodic audit trail review of users, data and alarms.
- Contribute to alarm rationalization and generate alarm reports.
- Performs investigation of manufacturing deviations related to automation and software. Recommends and implements Corrective Actions.
- Implements software changes and upgrades, supports troubleshooting and general diagnostics activities.
- Manages small projects related to equipment performance improvement as required.
- Authors and implements modification / change control procedures and protocols.
- Supports Validation department with initial design review, software testing, and protocol review.
- Performs maintenance, modifications and updates to automation network and servers.
- Performs 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 automation equipment.
- Performs any other related duties as assigned.
**Requirements**:
- Requires post-secondary education in Electrical, 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.
- Strong understanding of data integrity and knowledge of documentation required for cGMP process equipment.
- Strong PLC and HMI programming skills.
- Working knowledge of word processing, spreadsheet, and database management software
**Desired Characteristics**
- Ability to work well both independently and in a team environment.
- Strong English written and oral communication skills.
- Keen attention to detail
- Able to follow instructions and seek out support when required.
- Excellent analytical and problem-solving skills.
- Ability to articulate technical understanding to non-Automation SMEs.
- Compliance mind-set.
- Ability to respond to urgent situations.
- Tenacious to resolve problems and identify solutions.
OmniaBio 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 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.
Creation Date:
December 12, 2024
Revision Date:
December 12, 2024
Revision Number:
OBAUTOSPEC-20241212
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