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Fill Finish Jobs (NOW HIRING)

Intellectt INC

"cleaning validation"

Holly Springs, NC · On-site

Work on fill-finish processes and equipment validation. * Coordinate with cross-functional teams including manufacturing, QC, QA, and engineering. * Review and contribute to analytical method ...

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What does a typical day look like for someone working in Fill Finish operations?

A typical day in Fill Finish involves preparing and operating specialized filling and packaging equipment in a cleanroom setting, following strict aseptic and safety protocols to handle pharmaceutical or biotech products. You may participate in setup, calibration, and troubleshooting of machinery, as well as perform quality checks and detailed documentation to comply with regulatory standards. Team members often work closely with quality assurance, maintenance, and production planning staff to ensure seamless workflow. This collaborative environment offers valuable experience in regulated manufacturing and can open doors to supervisory or technical specialist positions with continued training and experience.

What is a Fill Finish job?

A Fill Finish job involves the final stages of pharmaceutical manufacturing, where drug products are aseptically filled into vials, syringes, or other containers and then sealed for distribution. This process requires precision, sterile conditions, and adherence to strict regulatory guidelines to ensure product safety and efficacy. Fill Finish roles often include equipment operation, quality control, and compliance with Good Manufacturing Practices (GMP).

What are the key skills and qualifications needed to thrive in the Fill Finish position, and why are they important?

To thrive in a Fill Finish role, you should have a background in life sciences or manufacturing, strong attention to detail, and experience working in Good Manufacturing Practice (GMP) environments. Familiarity with automated filling equipment, aseptic techniques, and relevant quality control systems or certifications (such as GMP or ISO) is often required. Strong teamwork, communication skills, and the ability to follow strict protocols set outstanding candidates apart. These skills ensure that pharmaceutical or biotechnology products are safely and efficiently filled, sealed, and packaged with the highest standards of quality and safety.

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Fill Finish jobs near you
Manager, QA Validation (Sterile Manufacturing)

Manager, QA Validation (Sterile Manufacturing)

MannKind Corporation

Danbury, CT

$116K - $174K/yr

Full-time

Re-posted 13 days ago

Job description

MannKind is committed to developing and commercializing innovative therapeutic products for patients living with endocrine and orphan lung diseases. We are on a mission to give people control of their health and the freedom to live life.
At MannKind, our employees are our number one asset, and we foster a tight-knit community where each of us plays a critical role in our collective success. We strive to provide a work environment where diversity of background, thought and perspective is valued and respected. Our team is also energized by the company’s entrepreneurial spirit that provides an environment in which you can evolve ideas quickly and nimbly.
Our Values serve as the foundation of MannKind’s culture. They define who we are, how we act, and guide our interactions every day—both with each other and the customers we serve. At MannKind, you will work with people who are experts in their fields, see challenges as opportunities, are tenacious and push boundaries, bring creative and solutions-based thinking forward, and always believe in winning together.
Position Overview
The QA Validation Manager manages the validation activities supporting sterile drug product manufacturing and fill–finish operations. This role ensures that validation/qualification program/activities meet regulatory expectations and maintain a state of control across aseptic processing areas. The ideal candidate brings strong technical expertise in validation, proven project and people management skills, and deep understanding of sterile manufacturing and fill–finish processes. Adheres to quality and safety policies and procedures.
Key Responsibilities

Validation and People Management
Develop risk-based qualification/validation strategy to support the activities
Support generation, review and approval of validation deliverables such as plans, protocols and reports (supporting equipment, facility, utility, computerized systems and processes)
Supervise validation engineers/specialists (direct or contract) ensuring high technical competency and adherence to cGMP.
Aseptic amp; Fill–Finish Support
Provide QA oversight for validation activities including process validation, cleaning validation, equipment qualification (IQ/OQ/PQ), utility qualification, and computer system validation.
Oversee validation activities related to aseptic processing, sterilization (e.g., autoclaves, dry heat ovens), and environmental monitoring systems.
Evaluate and support qualification of cleanrooms, HVAC systems, compressed gases, WFI, and clean steam.
Participate in aseptic process simulations (media fills) and ensure validation readiness.
Support validation of formulation processes, sterile filtration, container closure systems, and visual inspection technologies.
Assess validation impact for changes to equipment, components, formulations, or process parameters.
Identify opportunities to optimize fill–finish validation strategies while maintaining compliance and product quality.
Contribute to development and revision of SOPs, templates, and quality standards related to aseptic processing and fill–finish validation.
Quality Systems and Compliance
Apply Quality Risk Management (ICH Q9) principles to validation strategies and decisions.
Support investigations related to validation deviations, equipment failures, or sterility assurance risks
Ensure validation activities align with FDA, EMA, ICH, Annex 1, and industry best practices for sterile and fill–finish operations.
Support regulatory inspections and internal audits, serving as the subject matter expert for validation.

Required Qualifications/Skills
Bachelor’s or master’s degree in engineering, Life Sciences, or related field.
8+ years of experience (6+ years for master’s degree) in validation/QA within a GMP sterile manufacturing or fill–finish environment.
3+ years of experience in people management (direct or contract)
Strong understanding of aseptic processing, sterilization, contamination control, fill–finish and packaging operations.
Working knowledge of validation lifecycle principles, risk management, and data integrity requirements.
Familiarity with regulatory expectations including FDA, EMA, ICH Q7–Q10, and EU Annex 1.
Excellent communication, documentation, and cross functional collaboration skills.
Preferred Qualifications
Experience with isolator‑based sterility testing and aseptic filling technologies.
Experience supporting regulatory inspections (FDA, EMA, MHRA).
Lean/Six Sigma or continuous improvement training.

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