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Automation Systems Specialist
2 months ago
We are seeking a dedicated professional to provide engineering support for automation systems, interfaces, and equipment within our organization. This role is crucial for ensuring the effective management of automation systems across various operational areas, including building, process, and laboratory environments. The position requires adherence to internal Good Manufacturing Practices (GMP), Computer System Validation (CSV), and external regulatory standards.
Key Responsibilities:
- Oversee the automation systems at the facility, including Building Automation Systems (BAS), Room Monitoring Systems (RMS), and automation of process and laboratory equipment.
- Manage the overall automation asset care strategy, including upgrades, maintenance contracts, and modifications.
- Support and execute automation qualification processes and address any automation-related challenges.
- Ensure compliance with cGMP, Data Integrity, and CSV standards in alignment with both internal and external regulatory requirements.
- Develop and update User Requirement Specifications, Functional Specifications, Design Specifications, and Operation and Maintenance documentation for both new and existing control systems.
- Innovate solutions to complex challenges by adapting standard automation principles.
- Collaborate closely with manufacturing, engineering, utility operations, maintenance, quality assurance, and qualification teams to manage a diverse project portfolio.
- Lead and execute automation projects from inception to completion.
- Formulate Project Commission Plans and Strategies.
- Identify and resolve project deficiencies and deviations.
- Develop and implement project execution strategies tailored to customer requirements, including cost, schedule, functionality, and quality.
- Assist in preparing Project Initiation Documents, including Business Requirements, Work Breakdown Structures, Cost Breakdown Structures, and Project Scope Statements.
- Provide technical support to operational teams and support personnel.
- Manage and resolve corrective actions related to automation systems.
- Ensure compliance with technical, quality, and legal standards.
- Maintain reliable operation of automation systems with minimal downtime.
Qualifications:
- Bachelor's degree in engineering, computer science, automation, or a related field, or equivalent relevant experience.
- A minimum of 2 years of relevant engineering experience in the Chemical, Pharmaceutical, or Food & Beverage sectors.
- Strong oral and written communication skills.
- Familiarity with FDA regulations, particularly 21 CFR part 11, and GMP systems.
- Knowledge of industry standards, including Data Integrity, Validation, and GAMP, with the ability to work in controlled environments requiring specific gowning.
- Comprehensive technical knowledge, particularly in a GMP-regulated environment.
- Experience with automation systems (e.g., Continuum, Siemens, DeltaV, PLCs) and knowledge of IT infrastructure related to automation systems.
- Ability to work effectively in a team-oriented environment with strong computer skills.
- Working knowledge of P&ID and loop diagram standards, including instrumentation for temperature, pressure, flow, weight, humidity, and more.
Compensation:
The expected salary range for this position is between $92,800 and $139,200 per year, with variations based on individual factors such as market location, job-related knowledge, skills, and experience. The total compensation package may also include additional elements such as bonuses, stock units, and a comprehensive benefits package.
Commitment to Diversity & Inclusion:
We embrace diversity and are committed to creating an inclusive workplace that fosters innovation through collaboration and empowers our team members to reach their full potential.