Production Operations Specialist

1 week ago

Bedford, Massachusetts, United States Anika Full time

Position Overview:

This role requires minimal oversight, as the individual will be responsible for delivering operational excellence and skill-based training both on the production floor and in training environments. The Production Operations Specialist will collaborate with manufacturing supervisors to conduct timely reviews of batch records and exception documentation. This position will serve as the primary resource for skills development training for Gel manufacturing operators and will play a pivotal role in the execution of Anika's Operational Excellence initiative. The specialist will work closely with Operations management to educate personnel on Lean manufacturing principles, enhancing efficiency while minimizing waste. The individual will also partner with area supervisors to ensure optimal utilization of materials and equipment, while tracking the progress of process enhancements. Additionally, this role involves overseeing the ordering and monitoring of Gel manufacturing materials through a Kanban system.

Key Responsibilities:

  • Review completed Gel production batch records and documentation prior to submission for quality assurance.
  • Facilitate training and scheduling for Operational Excellence, ensuring accountability and sustainability.
  • Monitor operations readiness, including SAP/ERP material consumption, orders, transactions, material expiry, and availability. Execute necessary real-time ERP transactions related to material receipt or consumption.
  • Serve as a subject matter expert for major processes within Gel manufacturing, performing critical steps as needed and collaborating with supervisors to provide comprehensive skill development training to junior staff. Evaluate staff skill sets and offer feedback to supervisors.
  • Revise and create standard operating procedures, batch records, and work instructions to enhance usability and compliance.
  • Assist supervisors, engineers, and facilities with the initiation of Change Controls, CAPAs, deviations, or investigations of varying complexities, collaborating with cross-functional teams to identify root causes.
  • Implement process resolutions and improvements for both existing and future manufacturing processes.
  • Recommend and execute process changes or enhancements related to safety and ergonomics.
  • Participate in inspection readiness and support activities, conducting data analysis as required.

Supervisory Duties:

  • Responsible for interviewing candidates, as per managerial discretion.
  • Act as the point of contact for onboarding new manufacturing employees and serve as a resource/subject matter expert.

Required Experience, Knowledge, and Skills:

  • Bachelor's degree in Chemistry, Chemical Engineering, or equivalent experience.
  • Experience collaborating with technical leadership on projects.
  • Basic proficiency in Microsoft Word, Excel, and PowerPoint.
  • Exceptional verbal and written communication skills.
  • Strong organizational and tracking abilities with a keen attention to detail.
  • Capability to prioritize tasks and escalate issues when necessary.
  • Proficiency in performing computer-based real-time ERP transactions and material ordering.
  • Flexibility to work varied hours to complete work activities.
  • Ability to wear personal protective equipment, including safety glasses, gloves, and safety shoes.
  • Capacity to gown and gain access to biotechnology/pharmaceutical manufacturing areas.
  • Physical ability to lift, pull, or push equipment requiring up to 25-50 lbs. of force.
  • Ability to stand for extended periods in a production environment.
  • Willingness to work around chemicals, including alcohols, acids, and bases.

Preferred Experience, Knowledge, and Skills:

  • 6-8 years of experience in cGMP manufacturing with a High School Diploma or equivalent, or a Bachelor's degree in Chemistry, Chemical Engineering, or a related field.
  • 2+ years of experience leading teams in a cGMP environment.
  • Experience working in clean room settings or utilizing aseptic techniques.
  • Familiarity with commercial-scale automated equipment, including troubleshooting.
  • Experience in leading a results-driven team environment.
  • Experience performing ERP transactions using SAP and maintaining spreadsheets.

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