Assistant Process Manager

at  Thermo Fisher Scientific

JOB DESCRIPTION

As part of the Thermo Fisher Scientific team, you’ll discover meaningful work that makes a positive impact on a global scale. Join our colleagues in bringing our Mission to life every single day to enable our customers to make the world healthier, cleaner and safer. We provide our global teams with the resources needed to achieve individual career goals while helping to take science a step beyond by developing solutions for some of the world’s toughest challenges, like protecting the environment, making sure our food is safe or helping find cures for cancer.

SUMMARY:

Under the direction of the Process Manager, support daily operations and other technical aspects of simultaneous production in Manufacturing; resolve discrepancies, CAPAs, and engineering projects; drive continuous improvement in EH&S/Quality/Efficiency

EDUCATION:

Requires a minimum of bachelor’s degree in chemical engineering, Chemistry, or related field.

EXPERIENCE:

Previous experience in a pharma is preferred.

RESPONSIBILITIES:

• Provide oversight and technical expertise for daily Manufacturing operations (Troubleshooting, Changeover, Maintenance).
• Generate Process Flow Diagrams, manufacturing procedures, recipes, and BDR specifications.
• Support the Process Manager to meet production goals and requirements in a safe, compliant, and cost-effective manner.
• Interact with internal and external stakeholders to provide information in response to inquiries about products and services.
• Apply technical knowledge, expertise, experience, and good decision making to resolve manufacturing related problems, complaints, and quality related issues. Make process improvement recommendations.
• Troubleshoot process/equipment and resolve issues.
• Drive continuous improvement in EH&S/Quality/Efficiency to improve right first time in all areas.
• Proactively address safety, quality, housekeeping, and maintenance issues. Review and approve lifecycle documents including P&IDs, criticality assessments, Quality Risk Assessments, Qualification Validation documentation, and EH&S Process Hazards Analysis.
• Ensure documents are accurate and current.
• Partner with other departments to ensure all needed materials are available and released.
• Create/update MBRs, cleaning procedures, and SOPs and review batch records. Resolve high level issues for complex investigations, CAPAs, change requests, and engineering projects.
• Interacts with MSAT as LSM liaison. Lead PHAs and EH&S reviews.
• Develop process (and other) training materials and deliver training to Operations personnel.
• Administer, document and maintain the Quality Systems conformance to regulatory requirements and company policies where appropriate through effective utilization of Quality Systems tools, as well as direct actions.

DUTIES:

• Assist in Process / Technology Transfers.
• Assist with manufacturing process start-up.
• Manage Process Optimization and Capital improvements.
• Ensure Regulatory Compliance.
• May serve as the sites Preventative Controls Qualified Individual (PCQI) and/or Sanitation Supervisor for products being manufactured under 21 CFR 117 “Current GMP, Hazard Analysis, and Risk Based Preventive Controls for Human Food.
• Perform other duties as required.