Manufacturing Operations Specialist

Role Summary

Manufacturing Operations Specialist

Responsibilities

• Ensure accurate SAP inventories are maintained for all components and assist with monthly cycle counts
• Oversight of shopfloor area cleaning including aseptic Techniques, Clean room behaviors, and cleaning process.
• Oversight of planned activities in the shopfloor area to ensure compliance with area procedures and/or approved workplans.
• Setup materials for scheduled manufacturing processes
• Ability to gown aseptically and work in a clean room environment (ISO 8, areas for extended periods of time.
• Setup materials for scheduled manufacturing processes
• Perform review of logbook entries to ensure entries are accurate and legible.
• Aid in oversight of aseptic behaviors for all maintenance and cleaning activities on the shopfloor area
• Setup materials for scheduled manufacturing processes
• Equipment cleaning is performed as required
• Ensure proper status segregation, expiry, control, and storage of media lots and dispensary materials
• Ensure monthly safety and module walkthroughs are performed and follow up actions are addressed in a timely manner
• Documents all applicable steps in the relevant electronic systems and/or paper logs in line with GMP requirements.
• Qualified on proper aseptic techniques needed/applicable for the scope of this role.
• Plan and Perform proper environmental monitoring activities as needed.
• Perform review of logbook entries to ensure entries are accurate and legible.
• Proficient in the use of production related IT systems such as SAP, LIMS, MES.
• Execute MES activities to support Manufacturing Operations and Batch Record Review.
• Integrating and harmonizing best practices within your areas of expertise
• Role model Novartis‚Äôs Values and Behaviors. Enforces best in class cGMP, cGLP, and aseptic behaviors.
• Support deviation investigations that involve work environment
• Support lifecycle management of area SOPs and GWIs
• Accountable for maintaining an audit ready work environment
• Accountable for initiation of work orders for required area maintenance.
• Responsible for cross departmental communication during planned and unplanned events to ensure manufacturing operations start on time and within compliance.
• Perform miscellaneous duties to support evolving business needs

Qualifications

• High School Diploma or GED equivalent with 2+ years aseptic cGMP experience with strong preference in Cell and Gene.
• Bachelor‚Äôs degree in a relevant scientific discipline is preferred with a minimum of 1 year experience in cGMP or academic or lab setting with aseptic or cell culture experience.
• SAP/MES knowledge
• Strong interpersonal, written and communication skills along with problem solving and follow-up skills are required
• Environmental Monitoring and Aseptic experience preferred.
• Train the Trainer Certification
• Must be well organized, flexible, and work with minimal supervision
• Ability to lift up to 50 lbs.
• Alternate shifts, weekends and overtime will be required
• Requires handling of chemicals such as corrosives, solvents, and bio-hazardous materials

Skills

• SAP/MES proficiency
• Environmental Monitoring and Aseptic techniques
• Logbook and documentation management
• Environmental monitoring planning
• Effective communication and cross-functional collaboration

Education

• High School Diploma or GED required; Bachelor‚Äôs degree preferred in a relevant scientific discipline

Additional Requirements

• Alternate shifts, weekends and overtime required
• Physical ability to lift up to 50 lbs
• handling of chemicals such as corrosives, solvents, and bio-hazardous materials