BFS Filling Operator I

Paycom - ATS; Town of Florida (NY); On-site; USD 19,286,000 - 77,146,000; Full time

Benefits offered by this job

Medical/Dental/Vision Insurance

Paid Time Off

401k with employer match

Paid Holidays and Floating Holiday

Job summary

Aveva Drug Delivery Systems is seeking a BFS Operator to run filling equipment, perform in-process checks, and maintain documentation under GMP standards. You will help with setup, troubleshooting, cleaning, and training while collaborating with QA and Engineering to sustain continuous operations.

The role requires a high school diploma or GED, with an Associate degree favored, and experience in FDA-regulated manufacturing. Strong leadership and problem-solving skills are essential.

Qualifications

• Demonstrates leadership, coaching and manufacturing expertise with safety focus.
• Adheres to cGMP and follows policy, procedures and batch records.
• Proficient in SAP, MS Word and MS Excel; good communication in English.

Responsibilities

• Operate BFS filling equipment, set up and run production with quality checks.
• Perform in-process inspections and document batch data accurately.
• Coordinate with QA, Engineering and R&D to resolve issues and optimize.
• Train new employees and support preventive maintenance and housekeeping.

Skills

Leadership

Coaching

Manufacturing expertise

GMP knowledge

Time management

Organizational skills

Problem solving

Education

High school diploma or GED

Associate degree preferred

Tools

SAP

MS Word

MS Excel

Web Navigation

Job description

Job Details

Job Location: Tamarac, FL 33321, Position Type: Full Time, Salary Range: $27.00 Hourly, Job Shift: Day

About Us

Aveva Drug Delivery Systems is a pharmaceutical manufacturer at the forefront of innovative drug delivery technologies. We are dedicated to advancing solutions that optimize the efficacy, safety, and precision of pharmaceutical treatments. Join our team and help shape the future of healthcare by contributing to the development of groundbreaking drug delivery systems that improve patient outcomes worldwide.

Job Summary

The Blow-Fill-Seal (BFS) Operator is responsible for the safe, efficient, and compliant operation of BFS manufacturing equipment to produce high-quality pharmaceutical products. This role involves equipment setup, operation, in-process inspections, troubleshooting, and cleaning in accordance with GMP standards. The operator monitors critical process parameters, maintains accurate batch documentation, and collaborates with cross-functional teams to resolve issues and support continuous operations. Additional responsibilities include training new employees, supporting preventive maintenance, ensuring compliance with safety and quality standards, and contributing to process improvements and housekeeping initiatives.

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, andall other relevant duties as assigned.
• Works as a member of the team to achieve all outcomes.

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.

Benefits

Aveva Drug Delivery Systems and DifGen Pharmaceuticals provides a comprehensive benefits plan

• Medical/Dental/Vision Insurance
• Paid Time Off
• 401k with employer match
• Paid Holidays and Floating Holiday

Equal Opportunity Employer