Process Automation Consultant

2 weeks ago


Indiana, Pennsylvania, United States Healthcare Businesswomen's Association Full time
Job Overview
We are seeking a dedicated professional to provide engineering support for automation systems, interfaces, and equipment within our organization. This role is pivotal in ensuring the effective management of automation systems across various facilities, including buildings, processes, and laboratories. Compliance with internal Good Manufacturing Practices (GMP), Computer System Validation (CSV), and external regulatory standards is essential.

Key Responsibilities:
  • Oversee the automation systems at the facility, including building automation systems (BAS), room monitoring systems (RMS), and laboratory equipment automation.
  • Manage the overall automation asset care strategy, including upgrades, maintenance contracts, and system modifications.
  • Support and execute automation qualification processes and address all automation-related challenges.
  • Ensure adherence to cGMP, Data Integrity, and CSV compliance with all internal and external regulatory requirements.
  • Develop and update User Requirement Specifications, Functional Specifications, and Design Specifications for both new and existing control systems.
  • Innovate solutions to complex issues by adapting standard automation technical principles.
  • Collaborate closely with manufacturing, engineering, utility operations, maintenance, quality assurance, and qualification teams to manage a diverse range of projects.
  • 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 needs, including cost, schedule, functionality, and quality.
  • Assist in preparing Project Initiation Documents, including Business Requirements, Work Breakdown Structure, Cost Breakdown Structure, and Project Scope Statements.
  • Provide technical support to operations 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 industries.
  • Strong oral and written communication skills.
  • Knowledge of FDA regulations, particularly 21 CFR part 11 and GMP systems.
  • Familiarity with industry standards such as Data Integrity, Validation, and GAMP.
  • Comprehensive technical knowledge, particularly in a GMP-regulated environment.
  • Experience with automation systems, including Continuum, Siemens, DeltaV, and PLCs, along with knowledge of IT infrastructure related to automation systems.
  • Ability to work effectively in a team environment and possess strong computer skills.
  • Working knowledge of P&ID and loop diagram standards, including instrumentation for temperature, pressure, flow, weight, and humidity.

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 sign-on bonuses, stock options, and a comprehensive benefits package.

Commitment to Diversity & Inclusion:
We are dedicated to fostering a diverse and inclusive workplace that encourages innovation through collaboration and empowers our team members to reach their full potential.

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