Validation & Engineering Group Inc.
LL02-250725 Validation Specialist for Aseptic Process/Media Fill ...
Validation & Engineering Group Inc. - Indianapolis, Indiana, United States, 46231
Work at Validation & Engineering Group Inc.
Overview
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Overview
Validation & Engineering Group, Inc.
(V&EG) is a leading services supplier who provides solutions for the Pharmaceutical, Biotechnology, Chemical, Food, and Medical Devices industries in the following areas: Laboratory, Compliance, Computer, Engineering, Project Management, Validation, and other services.
We are seeking a talented, dedicated individual committed to work under the highest ethics standards for the following position: Validation Specialist - Aseptic Process / Media Fill
Position Summary: The Validation Specialist for Aseptic Processes and Media Fill is responsible for planning, executing, and documenting validation activities related to aseptic processing, with a specific focus on aseptic process simulations (APS/media fills). The role supports validation lifecycle management, ensuring compliance with regulatory requirements and company standards for sterile manufacturing.
Key Responsibilities: •Lead the
planning, coordination, execution, and reporting of Media Fills / Aseptic Process Simulations (APS)
in compliance with FDA, EU Annex 1, and internal policies. •Prepare and maintain
media fill protocols, risk assessments, and summary reports
in alignment with validation master plans. •Support the
qualification of cleanrooms, personnel, equipment, and processes
used in aseptic manufacturing. •Coordinate with Microbiology, QA, Manufacturing, and Engineering to ensure readiness for media fills, including
line clearance, gowning qualifications, and personnel scheduling . •Review and trend media fill data, EM results, and interventions to ensure
process robustness and aseptic control . •Support investigations and CAPAs related to
media fill failures, aseptic interventions, or environmental deviations . •Assist in the
validation of sterilization processes , including steam, dry heat, filtration, and sanitization procedures. •Participate in the development and execution of
cleanroom qualification protocols , airflow visualizations (smoke studies), and process simulations. •Support the creation, review, and approval of
validation documentation, SOPs, and work instructions
for aseptic processes. •Act as SME during
internal audits and regulatory inspections
for aseptic validation activities. •Collaborate in
continued process verification (CPV)
and ongoing qualification strategies.
Required Qualifications: •Bachelor's or Master's degree in Life Sciences, Engineering, Pharmacy, or a related field. •5+ years of experience in validation, aseptic processing, or sterile manufacturing in a GMP-regulated environment. •Strong understanding of
FDA aseptic guidance, EU Annex 1, USP
,
,
, and related validation guidelines. •Demonstrated experience with
media fill design, execution, and documentation . •Strong attention to detail and experience with
risk-based validation approaches . •Excellent technical writing, organizational, and cross-functional collaboration skills.
Preferred Qualifications: •Experience with
isolator or RABS-based aseptic systems . •Knowledge of
visual inspection validation, filling line qualification, and cleanroom behavior qualification . •Familiarity with
VMPs, CQV (Commissioning, Qualification, Validation) , and quality risk management (QRM) practices. •Involvement in regulatory inspections (FDA, EMA, MHRA) as subject matter expert.
(V&EG) is a leading services supplier who provides solutions for the Pharmaceutical, Biotechnology, Chemical, Food, and Medical Devices industries in the following areas: Laboratory, Compliance, Computer, Engineering, Project Management, Validation, and other services.
We are seeking a talented, dedicated individual committed to work under the highest ethics standards for the following position: Validation Specialist - Aseptic Process / Media Fill
Position Summary: The Validation Specialist for Aseptic Processes and Media Fill is responsible for planning, executing, and documenting validation activities related to aseptic processing, with a specific focus on aseptic process simulations (APS/media fills). The role supports validation lifecycle management, ensuring compliance with regulatory requirements and company standards for sterile manufacturing.
Key Responsibilities: •Lead the
planning, coordination, execution, and reporting of Media Fills / Aseptic Process Simulations (APS)
in compliance with FDA, EU Annex 1, and internal policies. •Prepare and maintain
media fill protocols, risk assessments, and summary reports
in alignment with validation master plans. •Support the
qualification of cleanrooms, personnel, equipment, and processes
used in aseptic manufacturing. •Coordinate with Microbiology, QA, Manufacturing, and Engineering to ensure readiness for media fills, including
line clearance, gowning qualifications, and personnel scheduling . •Review and trend media fill data, EM results, and interventions to ensure
process robustness and aseptic control . •Support investigations and CAPAs related to
media fill failures, aseptic interventions, or environmental deviations . •Assist in the
validation of sterilization processes , including steam, dry heat, filtration, and sanitization procedures. •Participate in the development and execution of
cleanroom qualification protocols , airflow visualizations (smoke studies), and process simulations. •Support the creation, review, and approval of
validation documentation, SOPs, and work instructions
for aseptic processes. •Act as SME during
internal audits and regulatory inspections
for aseptic validation activities. •Collaborate in
continued process verification (CPV)
and ongoing qualification strategies.
Required Qualifications: •Bachelor's or Master's degree in Life Sciences, Engineering, Pharmacy, or a related field. •5+ years of experience in validation, aseptic processing, or sterile manufacturing in a GMP-regulated environment. •Strong understanding of
FDA aseptic guidance, EU Annex 1, USP
,
,
, and related validation guidelines. •Demonstrated experience with
media fill design, execution, and documentation . •Strong attention to detail and experience with
risk-based validation approaches . •Excellent technical writing, organizational, and cross-functional collaboration skills.
Preferred Qualifications: •Experience with
isolator or RABS-based aseptic systems . •Knowledge of
visual inspection validation, filling line qualification, and cleanroom behavior qualification . •Familiarity with
VMPs, CQV (Commissioning, Qualification, Validation) , and quality risk management (QRM) practices. •Involvement in regulatory inspections (FDA, EMA, MHRA) as subject matter expert.