Job Description

Position Overview:

Our top Pharmaceutical Manufacturing client is seeking a skilled Drug Substance Process and Automation Consultant to support ongoing automation operations. Our client is currently experiencing bottlenecks with its DeltaV scripts, leading to a need for an expert to join the team and assist in establishing better automations and processes.

Key Responsibilities:

Process Optimization and Efficiency

• Work with the automation/site automation team, manufacturing team(s), facilities automation team(s), process development, and process engineering teams to smooth out bottlenecks within DeltaV scripts.
• Identify and address gaps in the automation process within DeltaV
• Serve as the liaison between automation and process development teams
• Assist in familiarizing peer teams and professionals with DeltaV scripts/automation processes, parameters, subroutines, etc.
• Access and review up to 25 documents with parameters.
• Identify and implement process improvements to reduce cycle times, increase output, and ensure the highest quality standards.
• Collaborate with production teams to resolve issues related to equipment, process variability, and system bottlenecks.
• Drive automation and integration initiatives to enhance the reliability and scalability of processes.

Safety and Compliance

• Ensure a safe working environment by adhering to and enforcing all Health, Safety, and Environmental (HSE) policies and guidelines.
• Participate in safety audits, hazard assessments, and safety improvement activities.
• Promote a culture of safety by ensuring that proper personal protective equipment (PPE) is utilized and that safety standards are met or exceeded.

Technical Documentation and Training

• Develop and maintain detailed process documentation, including standard operating procedures (SOPs), work instructions, and training materials.
• Train operators and maintenance personnel on new equipment, processes, and best practices to ensure consistent and safe operation.
• Ensure that all processes and equipment adhere to GMP, regulatory, and corporate quality standards.

Continuous Improvement

• Monitor performance metrics and KPIs to track the effectiveness of process improvements.
• Analyze data to identify trends and opportunities for further optimization.
• Lead continuous improvement initiatives by applying Lean Six Sigma, Kaizen, or other methodologies to increase process efficiency.

Core Skills and Experience:

• Process Control Systems (Delta-V PCS): Proficiency in Delta-V PCS for process control and integration, including troubleshooting and configuring system components.
• Commissioning & Qualification (C&Q): Experience in C&Q processes for packaging equipment and device lines, with a thorough understanding of operational readiness, testing protocols, and documentation.
• Validation and Regulatory Compliance: Hands-on experience in process validation and a solid understanding of GMP and regulatory requirements for pharmaceutical packaging processes.
• Analytical and Problem-Solving Skills: Proven ability to identify root causes of packaging process issues and implement effective corrective actions and continuous improvements.

Preferred Qualifications:

• Bachelor’s Degree in Engineering (Mechanical, Packaging, Chemical, or related field).
• Certification in packaging engineering or related disciplines.
• Knowledge of Pharmaceutical Device Operations and familiarity with equipment such as labelers, sealers, automated packaging systems, or auto injectors.
• Strong Communication and Documentation Skills: Able to clearly communicate technical information, collaborate effectively across departments, and maintain accurate project documentation.

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