Aseptic Filling Validation Specialist

Organization
HackEd
Job Location
Walkersville, MD 21703
Salary
Competitive
Job Description

We are looking for a Aseptic Filling Validation Specialist in walkersville, MD working at Lonza.

 

Develop complex aseptic processing cleanroom qualification protocols including HVAC qualification, Environmental monitoring, and media fill protocols for execution. This role also develops protocols for qualification of automated, semi-automated and manual aseptic filling processes.

 

Schedules and tracks Aseptic  protocol executions. This includes coordination with Scheduling and Manufacturing.

 

Protocol close-out activities including drafting of summary reports, obtaining sample results via LIMS, maintaining execution tracker and discrepancy reports generation.

 

Work to identify efficiencies in Validation program approach. Work to apply lessons learned and stay informed of industry regulatory changes as it applies to Aseptic Filling validation.

 

Perform assigned Quality Systems activities including: Document Management System (DMS), Information Management System (ProCal) and Trackwise system (Change Control, Deviations, CAPA, etc.).

 

Act as point person for customer communications as assigned

 

Participate in Audits and Inspections

Provide SME level expertise

Perform other duties as assigned. 

 

Safety

Must know and follow job safety procedures, attend required health and safety training, proactively promote safety at work, and promptly report actual and potential accidents and injuries.  Must comply with safety policies of the company and site. 

 

Quality Responsibility

Adherence to cGMPs is required at all times during the manufacture of APIs.  All personnel own the quality of what they deliver and are responsible for notifying responsible management in a timely manner of regulatory inspections, serious GMP deficiencies, process deviations, product defects and related actions.

 

Environmental Demands

All office areas, manufacturing areas and facility areas plant wide.

 

Education: Bachelor’s degree

Preferred area of study:  Science or technical discipline.

Experience: Minimum 6 years of industry experience. Experience in performing aseptic cleanroom validation including aseptic process simulations.

 

Requirements

Knowledge
Strong understanding of FDA Aseptic Processing Guidance and EU Annex 1 regulations. Complete understanding of cGMP’s. Knowledge of ISO 14644 cleanroom qualification requirements.
Skills
Excellent technical writing skills and ability to document all work in a meticulous, accurate, and timely manner.
Excellent written and oral communication skills and ability to work. interdepartmentally in an effective manner to carry out daily duties.
Excellent organizational, scheduling and time management skills.
System Matter Expert (SME) level of Aseptic Filling Validation knowledge.
Provides training to other team members.


Qualities & Attitude
Exercises judgment within defined procedures and practices to determine appropriate action.
Self-motivated team player.
Completes assignments on-time and accurately.
Displays commitment to quality and performs job functions to the best of his/her ability.
Works to share knowledge with other team members.
Seeks knowledge of regulatory guidance and industry trends and strives to apply knowledge to the Lonza Aseptic Filling program.


How to Apply

Send resume, name and job title to sherita.smaw@hackeducate.com

 

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