Specialist, Control Systems

3 weeks ago

Brantford, Canada Apotex Pharmachem Inc. Full time

**About Apotex Inc.**

Apotex Inc. is a Canadian-based global health company that produces high-quality, affordable medicines for patients around the world. Apotex employs almost 7,200 people worldwide in manufacturing, R&D, and commercial operations. Apotex medicines are accessible to patients in more than 75 countries globally. Through vertical integration, the Apotex group is focused on the development and sale of generic, biosimilar and specialty products.

**Job Summary**:
**Responsibilities**:

- Performs activities related to design, commissioning, performance improvement, and troubleshooting of computer control assisted processing equipment.
- Provides design/approval of hardware, software, and controls for computer assisted equipment.
- Provides technical computer system operational support to Manufacturing and Facilities.
- Implements software/hardware changes and upgrades, understands impact of actions to Manufacturing and Facilities and process.
- Implements modification/change control procedures and protocols.
- Supports Validation Department with initial design review, software testing, protocol execution and review.
- As the responsibility of a DeltaV administrator, ensure the DeltaV system is operating as per qualified requirements and maintained in a robust state while conforming to our change management system.
- Supports QA and the Engineering Department during regulatory agency inspections with ownership for investigations, audits, training for automated and control systems.
- Works in a safe manner collaborating as a team member to achieve all outcomes.
- Demonstrate Behaviours that exhibit our organizational Values: Collaboration, Courage, Perseverance, and Passion.
- Ensure personal adherence with all compliance programs including the Global Business Ethics and Compliance Program, Global Quality policies and procedures, Safety and Environment policies, and HR policies.
- Initiating, executing, and tracking progress of change control records
- Supporting and leading deviation management, CAPA and change control activities in quality management system
- Serving as automation SME to Quality, Manufacturing, Computer System Validation and other functions
- Support manufacturing and process investigations and improvement studies like OOS, OOT, RCAs etc.
- Developing departmental procedures for documentation of automated systems, from specifications through standard operating procedures (SOPs)
- All other relevant duties as assigned.

**Job Requirements**:

- Education
- Requires BS/BA in Engineering (or equivalent technical degree)
- PEO license or eligibility for license preferred but not required.
- Knowledge, Skills and Abilities
- Strong PLC and HMI programming skills; must have proven hands on experience in PLC/HMI logic programming and troubleshooting systems in a pharmaceutical or biopharmaceutical manufacturing facility..
- Experience designing and programming control systems with Emerson DeltaV DCSExperience in configuring and testing communication protocols like MODBUS, DeviceNet, Fieldbus
- Strong knowledge of process control and machine automation in biotech or pharmaceutical manufacturing facility.
- Working knowledge of engineering documentation required for cGMP process equipment, Software Lifecycle Documentation and GAMP V guidelines.
- Detailed understanding of cGMP software quality system principles and sanitary equipment design requirements.
- Knowledge of control system lifecycle management in a regulated environment
- Working knowledge of word processing, spreadsheet, and database management software.
- Strong communication skills.
- May require availability outside of business hours.
- Experience
- Minimum of five years of experience in the design/build/programming troubleshooting and maintenance of PLC control systems and data acquisition systems in a pharmaceutical or biopharmaceutical manufacturing facility.

At Apotex, we are committed to fostering an inclusive, accessible work environment, where all employees feel valued, respected and supported.

Apotex offers accommodation for applicants with disabilities as part of its recruitment process. If you are contacted to arrange for an interview or testing, please advise us if you require an accommodation.

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