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Lead Automation Specialist
2 months ago
The Lead Automation Specialist plays a crucial role in delivering technical guidance and oversight for the execution of pivotal projects that contribute to the success of the organization. At BioPharma Consulting JAD Group, this position entails collaborating with diverse teams to guarantee the effective functioning and upkeep of automation systems in alignment with industry regulations.
Key Responsibilities:
- Ensure compliance with regulatory standards such as 21 CFR Part 11 and cGMP during validation activities.
- Integrate GMP-compliant systems with the Corporate IT framework.
- Engage in system development and architectural design.
- Provide ongoing support for Building Management and Process Control Systems.
- Program, code, and configure control systems effectively.
- Set up and maintain DeltaV Batch recipes, virtualization, and OSI Soft PI Historian.
- Facilitate the transfer of technologies, recipes, and parameters to commercial production.
- Maintain documentation and specifications for automation systems.
- Develop and uphold Standard Operating Procedures (SOPs) and training for automation systems.
- Implement Engineering Test Plans and Software Test Specifications.
Essential Skills & Qualifications:
- Familiarity with Weight and Dispense and Electronic Batch Record (EBR) systems.
- Experience in SCADA design, implementation, and operation.
- Capability to create new code for continuous and batch control systems.
- Expertise in BMS, SCADA, and DCS design, commissioning, and validation within a GMP environment.
- Knowledge of GAMP, SDLC methodologies, and CAPA.
- Understanding of 21 CFR Part 11 compliance.
- Proficiency in various communication protocols.
- Experience with DCS, SCADA, and BMS systems such as DeltaV, FactoryTalk View, and APOGEE.
- Dependable, self-driven, and collaborative with a positive outlook.
- Ability to work independently in a fast-paced environment.
- Strong time management skills and the ability to prioritize tasks effectively.
- Excellent written, verbal, and interpersonal communication abilities.
- Meticulous attention to detail with the capacity to draft and refine maintenance procedures for technical equipment.
- Proficient in MS Office applications (Word, Excel, Outlook, PowerPoint).
Educational Background:
- Bachelor's Degree in Chemical, Electrical, or Mechanical Engineering, or five years of relevant experience in automation engineering.
- Experience with critical utility and non-GMP utility systems is advantageous.
