Job Title

Requisition

Location

Additional Locations

Job Description

The Operations Specialist II is responsible for performing production activities in compliance with applicable government regulations and guidelines as well as with company policies and procedures. The Operations Specialist II is a senior level operator and is expected to possess a strong technical knowledge of manufacturing operations.

• Ensure safe task execution and report safety concerns promptly.

• Complete required training for production tasks.

• Carry out daily production activities, including preparation, filling, and packaging.

• Follow daily and weekly production schedules.

• Communicate schedule changes with leads and QA to maintain production requirements and safety standards.

• Adhere to production batch records and procedures, ensuring compliance with policies and cGMPs.

• Procure components for manufacturing operations and conduct inventory checks to prevent interruptions in production.

• Monitor logbooks daily for compliance.

• Perform equipment cleaning and maintenance as needed.

• Assist in process deviation investigations with QA.

• Participate in Continuous Improvement initiatives and support validation lifecycle activities.

• Provide assistance across the production department and maintain facility cleanliness.

• High school diploma required, PTEC (Process Technology) degree preferred

• 5+ years' experience working in a manufacturing environment with technical background in Chemistry or Compressed Gases

• Proficient in manufacturing SAP transactions

• Ability to read and understand piping and instrumentation drawings and process flow charts

• Strong leadership skills with a results-oriented approach as well as the ability to train, motivate, and otherwise develop resources

Preferences:

• Prior exposure within a manufacturing environment subject to FDA regulations

• Knowledge of cGMPs and Good Documentation requirements

• Experience using ERP system such as SAP

Officially supervised by Manufacturing Area Supervisor.

Current work schedule is four 10-hour days per week, but subject to change. Work is mostly performed indoors. Occasional periods of work outdoors required. This is a 100% onsite role.

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