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Manager Aseptic Processing Jobs in Pennsylvania (NOW HIRING)

Aseptic Production Manager

Bethlehem, PA · On-site

  • Medical

  • Retirement

  • PTO

As the Aseptic Production Manager, you will lead the efficient and safe operation of Aseptic ... Process Standardization: · Standardize processes, procedures, SOPs, and work instructions for ...

Aseptic Equipment Mechanic

Bethlehem, PA · On-site

$25.75 - $33.75/hr

  • Medical

  • PTO

... Processing, Filling and Packaging Equipment are maintained to ensure Production and Quality ... Self-managed, Self-motivated, Independent * Communication and Prioritization Skills

Batching Manager

Hazleton, PA · On-site

  • Medical

  • Dental

  • Vision

  • Life

  • Retirement

  • PTO

Manages and directs activities of the aseptic batching department, ensuring product adheres to ... Collaborates with System Engineers, R&D and commercialization on Aseptic process improvements.

Batching Manager

Hazleton, PA

  • Medical

  • Dental

  • Vision

  • Life

  • Retirement

  • PTO

Manages and directs activities of the aseptic batching department, ensuring product adheres to ... Collaborates with System Engineers, R&D and commercialization on Aseptic process improvements.

Batching Manager

Hazle Township, PA · On-site

  • Medical

  • Dental

  • Vision

  • Life

  • Retirement

  • PTO

Manages and directs activities of the aseptic batching department, ensuring product adheres to ... Collaborates with System Engineers, R&D and commercialization on Aseptic process improvements.

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Manager Aseptic Processing information

What is a manager aseptic processing?

A Manager of Aseptic Processing oversees the sterile production environments in pharmaceutical or biotechnology manufacturing. They are responsible for ensuring that products are processed and packaged without contamination, following strict regulatory and safety standards. Their role includes supervising staff, maintaining compliance with Good Manufacturing Practices (GMP), conducting risk assessments, and implementing process improvements. They also play a key part in training employees and managing documentation to ensure product quality and patient safety.

What are the key skills and qualifications needed to thrive as a manager aseptic processing?

To thrive as a Manager Aseptic Processing, you need a strong background in microbiology, pharmaceutical manufacturing, quality assurance, and regulatory compliance, often supported by a relevant degree and experience in sterile production environments. Familiarity with Good Manufacturing Practices (GMP), cleanroom management systems, and environmental monitoring tools is essential. Leadership, attention to detail, and effective communication are crucial soft skills for managing teams and ensuring strict adherence to protocols. These skills and qualities are vital to maintain product sterility, meet regulatory standards, and ensure patient safety in pharmaceutical operations.

What are some common challenges faced by a manager aseptic processing, and how can they be addressed?

Managers in Aseptic Processing often face challenges related to ensuring strict compliance with regulatory standards, maintaining a contamination-free environment, and leading cross-functional teams in high-pressure situations. Addressing these challenges requires staying updated on evolving industry guidelines, fostering a culture of continuous training, and implementing robust monitoring systems. Effective communication and collaboration with Quality Assurance, Maintenance, and Production teams are also crucial for swiftly resolving issues and upholding product safety.

What is the difference between Manager Aseptic Processing vs Aseptic Processing Technician?

AspectManager Aseptic ProcessingAseptic Processing Technician
CredentialsBachelor's degree in life sciences or related field, GMP training, leadership experienceHigh school diploma or associate degree, GMP training
Work EnvironmentSupervisory role overseeing aseptic processes in pharmaceutical manufacturingHands-on role operating aseptic equipment in cleanroom settings
ResponsibilitiesManaging teams, ensuring compliance, process optimizationPerforming aseptic procedures, equipment setup, documentation

The Manager Aseptic Processing oversees the aseptic manufacturing process, focusing on team management and compliance, while the Aseptic Processing Technician handles the direct operation of aseptic equipment. Both roles require GMP training and work in sterile environments, but the manager has additional leadership and oversight responsibilities.

What are popular job titles related to Manager Aseptic Processing jobs in Pennsylvania?

For Manager Aseptic Processing jobs in Pennsylvania, the most frequently searched job titles are:

What job categories do people searching Manager Aseptic Processing jobs in Pennsylvania look for?

The top searched job categories for Manager Aseptic Processing jobs in Pennsylvania are:

What cities in Pennsylvania are hiring for Manager Aseptic Processing jobs?

Cities in Pennsylvania with the most Manager Aseptic Processing job openings:

Manager, Quality & Food Safety-Low Acid Aseptic Food

Sunny Sky Products LLC

Douglassville, PA

Full-time

Re-posted 22 days ago


Job description

Job Summary

The Quality Assurance Manager is responsible for leading the Quality Assurance, Food Safety, and Regulatory Compliance programs for a low-acid aseptic beverage manufacturing facility producing dairy-based, plant-based (soy), coffee, creamers, and specialty beverage concentrates for the foodservice market. This position ensures compliance with FDA Low-Acid Canned Foods (21 CFR Part 113, where applicable), FSMA Preventive Controls (21 CFR Part 117), aseptic processing requirements, PMO requirements where applicable, customer standards, and GFSI/FSSC 22000 requirements. The QA Manager provides leadership for QA, sanitation, laboratory, environmental monitoring, supplier quality, and continuous improvement initiatives.

Major Job Functions

  • Lead the development, implementation, and continuous improvement of the Juice HACCP Plan, FSMA Preventive Controls Plan, Allergen Control, and Environmental Monitoring Programs.
  • Oversee the implementation and monitoring of preserved product validations, critical control points, and preventive control records to ensure compliance with food safety regulations.
  • Ensure compliance with preservative usage regulations, label declarations, and finished product specifications for preserved juice products.
  • Supervise the QA team, including lab technicians and sanitation staff. Provide ongoing training, coaching, and development.
  • Manage finished product release, hold/release programs, and customer specifications.
  • Maintain internal audit programs, perform mock recalls, and manage third-party inspections and regulatory audits (e.g., FDA, SQF, BRC).
  • Investigate product non-conformances and customer complaints; lead root cause analysis and implement Corrective and Preventive Actions (CAPAs).
  • Manage and verify cleaning validation processes for blending, filling, and CIP systems to prevent microbial and cross-contamination risks.
  • Ensure raw material and ingredient suppliers meet quality requirements; support Supplier Verification Program (SVP) and Foreign Supplier Verification Program (FSVP).
  • Coordinate with R&D, Operations, and Sales teams during new product commercialization to define quality standards and ensure food safety validation.
  • Monitor and verify lab testing results for pH, °Brix, microbiology (e.g., yeast, mold, total plate count), and preservative concentrations.
  • Manage and interact with customers and comply to additional food safety and quality standards of customers.
  • Oversee and manage the facilities food defense program
  • Oversee label and lot code verification, allergen control, and traceability programs.
  • Oversee the quality management system components and software ensure all components are up to date.
  • Develop training and oversee training implementation on all aspects of quality, foods safety, sanitation and regulatory compliance.
  • Oversee and maintain quality inspections, releases and control/disposition of non-conforming materials in ERP (SAP) system.
  • Provide support and assistance to Director of Quality as requested.
  • Combination of office and production floor environments.
  • Must be able to work in refrigerated and ambient conditions.
  • May require occasional weekend or off-shift work during audits, commissioning, or production issues.

Required Skills/Abilities/Education

  • Strong knowledge of FDA 21 CFR Part 117, Low-Acid Aseptic Processing requirements, GMPs, and FSSC 22000.
  • Experience managing aseptic low-acid beverage manufacturing (dairy, soy, coffee, or similar), pasteurization validations, and shelf-life determination.
  • Experience with pasteurization validation, preservative efficacy, and shelf-life determination.
  • Proficient in MS Office and QA documentation software.
  • PCQI certification required; HACCP certification required; FSSC/SQF Lead Auditor preferred.
  • Better Process Control School/low-acid food certification.
  • Knowledge of commercial sterility, UHT systems, CIP/SIP validation, environmental monitoring, and laboratory management.
  • Excellent leadership, communication, data analysis, and problem-solving skills.
  • Internal Auditor Certification (preferred)
  • Bachelor’s degree in Food Science, Microbiology, Chemistry, or related discipline.
  • Minimum 10 years of quality assurance experience in beverage or juice manufacturing. At least 4 years in a Quality Manager supervisory role.