BFS Filling Operator I

Key Responsibilities

• Gains and uses qualifications to perform process steps as necessary to support continuous operations, in accordance with Batch Record manufacturing instructions and current labor standards in order to safely and efficiently manufacture a quality product.
• Operates the BFS filling equipment through setup, startup, production, and cleaning. Ensures proper setup of the equipment extruder, parison, moulds, etc. during startup and makes necessary adjustments to maintain product quality and production efficiency.
• Performs in-process inspections of the product, including but not limited to fill weight measurement and calculation, vacuum leak tests, and visual and physical inspections of the product.
• Monitors and documents the critical process parameters during the manufacturing process.
• Responds promptly to any equipment issues that arise during filling production, problem-solves mechanical issues, and implements safe, compliant corrective measures to minimize manufacturing downtime.
• Assembles, disassembles, and cleans equipment and parts used for manufacturing in accordance with the applicable GMP procedure to ensure proper operation and cleanliness of the equipment.
• Escalates, notifies, and coordinates with supporting groups (Quality, Engineering, Technical Operations, R&D, etc.) and helps resolve issues.
• Performs daily review of batch documentation for accuracy and completeness. At the end of the batch, reviews all batch documentation for accuracy and completeness prior to submitting batch for review.
• Calculates and accurately weighs the required ingredient quantities used in production based on batch record, product type, and available raw materials. Documents and labels the materials weighed.
• Works with Quality Assurance to ensure the manufacturing process meets quality specifications.
• Works with engineering team to perform preventive maintenance of BFS machines and mould change process.
• Understands the production schedules and works independently to meet the production goals.
• Trains new employees on BFS operations and trouble shooting techniques, processes, and retrains as necessary.
• Aids Section Leader in assigning qualified personnel as required in the filling rooms to meet weekly production schedule including overtime scheduling as needed.
• Complies with and enforces GMP/GDP standards in order to minimize cross contamination, holding personnel directly accountable for compliance.
• Collaborates with Engineering department during major preventative maintenance or repairs, providing technical expertise and support.
• Assists with revising existing SOPs and developing new procedures as needed.
• Ensures housekeeping standards are followed and area is maintained during shift.
• Follows all departmental and company safety policies in order to prevent injury to self and others.
• Backfills associates in the processing rooms as needed, including packaging areas when required.
• Supports and promotes all Environmental, Health & Safety initiatives to ensure compliance with corporate and other regulations.
• Performs other duties in order to meet department's production schedule or to comply with cGMP.
• Works as a member of the team to achieve all outcomes.
• Operates in accordance with our Code of Conduct and Business Ethics, and all established regulatory, compliance and safety requirements.
• Performs all work in support of our Values: Collaboration, Courage, Perseverance, and Passion.
• Ensures area housekeeping / 5S initiatives are sustained, and all other relevant duties as assigned.

Qualifications

Education: High school diploma or general education degree (GED) required. Associate degree preferred.

Knowledge, Skills and Abilities

• Demonstrates thorough leadership, coaching skills, manufacturing expertise, safety measures knowledge, time management, organizational skills, and the ability to motivate workers.
• Understands, adheres to, practices Current Good Manufacturing Practices (cGMPs) and to observe safety, environmental, and security policies and procedures during the performance of all assigned responsibilities.
• Computer knowledge (e.g. SAP, Web Navigation, Email, MS Word and MS Excel).
• Ability to read English and comprehend documents such as policies, Standard Operating Procedures, batch records and cleaning procedures.
• Ability to write in English, and complete batch record documentation.
• Ability to speak English effectively.
• Must be able to use basic mathematical calculations in multi-level/complex formulas using whole numbers, common fractions, and decimals, following rounding and significant figure rules.
• Ability to apply common sense understanding to carry out detailed written and oral instructions.
• Ability to apply problem solving technics to address problems involving a few variables in standardized situations.
• Ability to move containers of ingredients, load ingredients into tanks and hoppers, transport mixing vessels on rolling casters, and climb steps.
• Ability to wear respiratory, hearing, gowning, and other personal protection as required.

Experience

• 3+ years' experience in Food/OTC or other FDA regulated manufacturing environment preferred. Experience in pharmaceutical manufacturing, biotechnology, or medical device manufacturing highly preferred.
• Experience in BFS filling operations for aseptic or sterile solutions highly preferred.