Aseptic Process Validation Specialist Job at Fagron (Wichita)

Commissioning & Qualification Specialist

Airswift is looking for a Commissioning & Qualification Specialist to work with ...

Location

United States , Birmingham

Salary:

Not provided

Airswift Sweden

Expiration Date

Until further notice

Requirements

Bachelor’s degree preferably in Engineering or Science discipline
3 to 5 experience in validation / qualification of aseptic pharmaceutical processes and / or equipment
Strong understanding of Regulatory Guidance Framework FDA/EU, Industry Best Practices and GMPs
Comprehensive knowledge of pharmaceutical manufacturing equipment and processes

Job Responsibility

Develop URS, SIC and SRA for new and existing aseptic facilities and equipment
Develop and execute Commissioning (COM) and Installation qualification (IQ) protocols
Perform operational qualification (OQ) and performance qualification (PQ) activities
Ensure all documentation is compliant with regulatory requirements and internal quality standards
Conduct risk assessments and implement mitigation strategies for aseptic processes
Proficient in the use of word processing, spreadsheet and presentation software programs
Proficient in use if Kaye Validator AVS and Val Probe Systems
Knowledge on following equipment qualifications: Homogenizers, Pump Skids, SIP & CIP Skids, Temperature control units, Tanks, Requalification of CTU’s
Develop and implement validation plans for computerized systems
Conduct risk assessments to identify potential issues related to system functionality and data integrity

New

Validation Specialist

Location

United States , Shawnee

Salary:

Not provided

Argenta

Expiration Date

Until further notice

Requirements

Bachelor’s degree in Engineering, Life Sciences, Pharmaceutical Sciences, or a closely related field, and 2 years of experience in pharmaceutical validation, quality systems, or related GMP-regulated environments. Must have hands-on experience conducting equipment qualification (IQ/OQ/PQ) for manufacturing and laboratory equipment. Must have experience with thermal validation using Ellab or equivalent systems, including thermocouple mapping and lethality validation. Must have experience leading or supporting sterilization validation (e.g., SIP, depyrogenation, or aseptic process simulations) aligned with ISO 17665 and PDA guidelines. Must have experience with computerized system validation (CSV) in accordance with 21 CFR Part 11, GAMP 5, and Data Integrity (ALCOA+) principles. Must have experience in process validation (PV) and continued process verification (CPV), including protocol drafting, sampling plans, execution, and statistical analysis. Must have experience in cleaning validation, including MACO and PDE-based limit calculations, toxicological risk assessments, and swab sampling strategies. Must have experience with statistical tools, including JMP, for data analysis, trend monitoring, and process capability assessments. Must have experience working with cloud-based system migrations and enterprise platforms (including SAP, Empower, MODA, and Fiix). Must have experience with Quality Management Systems (QMS), including document control, audit trail review, and deviation/CAPA processes. Must have experience with FDA 21 CFR Parts 210, 211, 820, EU Annex 1, and relevant ICH and PDA regulatory standards. Must have good written and verbal communication skills in English.

Job Responsibility

Develop User Requirement Specifications (URS), Functional Requirements (FRS), Configuration/Design Specifications, Risk Assessments, Requirement Traceability Matrices (RTMs), Validation Plans (VMP), Test Plans, and Validation Summary Reports (VSR). Execute validation lifecycle documents including Installation Qualification (IQ), Operational Qualification (OQ), and Performance Qualification (PQ) for both manufacturing and laboratory systems. Lead and support Process Validation (PV) activities: define sampling plans, verify Critical Process Parameters (CPPs), collect in-process and final product samples, and compile validation reports per ICH Q8–Q10. Support and execute Aseptic Process Simulations (Media Fills), including operator qualification, process simulation design, and result evaluation in compliance with sterility assurance standards. Perform Cleaning Validation, including swab sampling strategy, MACO/PDE-based residue limit calculations, and execution of cleaning protocols. Conduct validation of thermal processes such as Steam-in-Place (SIP) and Depyrogenation tunnels, including thermocouple mapping, endotoxin challenge studies, and F0 calculation using tools such as Ellab. Facilitate risk assessments for GxP computerized systems, ensuring compliance with 21 CFR Part 11, GAMP 5, and Data Integrity (ALCOA+) guidelines. Execute retrospective validation for legacy systems and close compliance gaps via change control, system remediation, and updated documentation. Support cloud-based system transitions and data migrations for systems such as SAP ByDesign, MODA, Empower, ZenQMS, and Fiix, ensuring business continuity and data integrity. Perform Continued Process Verification (CPV), using statistical tools such as JMP for trend analysis, control charting, and capability studies (Cp/Cpk). Serve as a validation representative during internal and regulatory audits
address audit findings through CAPAs and technical document revisions. Draft and review Standard Operating Procedures (SOPs), Risk Assessments, and final validation documentation for various qualification and compliance activities.

Fulltime

Operational Excellence Specialist

The Operational Excellence (OpEx) Specialist is a key driver of performance, com...

Location

United States , Canton

Salary:

Not provided

Fagron

Expiration Date

Until further notice

Requirements

Bachelor’s degree in Engineering, Life Sciences, Operations, or related field
3+ years of experience in pharmaceutical manufacturing, ideally in a 503B, 503A, or cGMP sterile environment
Working knowledge of Lean, Six Sigma, and structured problem‑solving tools
Strong understanding of aseptic processing, sterile filtration, and cleanroom operations
Ability to analyze complex data sets and translate insights into actionable improvements
Excellent communication and facilitation skills

Job Responsibility

Lead and facilitate Lean initiatives (5S, standard work, visual management, value stream mapping) across ISO‑7 and ISO‑5 operations
Identify bottlenecks in compounding, filtration, filling, and inspection workflows
implement sustainable solutions that improve flow and reduce cycle time
Conduct time studies, labor modeling, and capacity analysis to optimize staffing and equipment utilization
Develop and maintain KPIs and dashboards that drive daily performance management
Lead structured problem‑solving (DMAIC, 5‑Why, Fishbone, Fault Tree) for deviations, complaints, and recurring operational issues
Partner with QA to ensure CAPAs are data‑driven, effective, and closed on time
Support investigations related to aseptic behavior, environmental monitoring trends, filter validation gaps, and equipment performance
Develop and refine SOPs, batch records, and work instructions to ensure clarity, consistency, and audit readiness
Translate complex technical requirements into technician‑friendly procedures without compromising compliance

What we offer

competitive salary
comprehensive benefits
performance package
ability to be part of an international leader in an expanding industry

Fulltime

Packaging Specialist

At Nestlé Health Science, we believe that nutrition, science, and wellness must ...

Location

United States , Eau Claire

Salary:

Not provided

Nestle Health Science

Expiration Date

Until further notice

Requirements

Bachelor's degree in Food Science, Materials Science, Packaging Science, Packaging or Mechanical Engineering, or related field, with MS preferred
3+ years of packaging experience within the food and beverage industry
Proficient in Microsoft Office tools (Word, Excel, PowerPoint)
Clear understanding of packaging design, materials, equipment, and systems to include SAP
Understanding of project lifecycle management, including scope, schedules, and deliverables
Working knowledge of food safety, regulatory, and compliance standards
Experience with Aseptic packaging is strongly preferred
Ability to travel : 30%
Demonstrated project management experience leading or contributing to cross‑functional teams
Excellent written, verbal, and interpersonal communication skills with the ability to influence and align stakeholders

Job Responsibility

Support installation, commissioning, qualification, and validation of aseptic packaging processes and equipment
Ensure aseptic process parameters and operating conditions meet Nestlé standards
Partner with cross‑functional teams to identify design risks and opportunities to improve manufacturability and production efficiency
Resolve packaging design issues with Operations and recommend improvements to enhance performance and reliability
Contribute to the NHSc US CTAG sustainability roadmap in collaboration with NPTC‑TCU partners
Serve as packaging subject matter expert to drive improvements in productivity, quality, cost, sustainability, and consumer value
Lead or support development and implementation of new and improved packaging concepts, materials, and processes
Provide technical leadership in supplier selection and management
Partner with Procurement, Manufacturing, Quality, R&D, and Sales/Marketing to deliver material qualification and packaging initiatives
Support installation, commissioning, and line layout modifications for new or upgraded packaging equipment

What we offer

Supports physical, financial, and emotional wellbeing
Dynamic career paths
Robust development
Opportunities to learn from talented colleagues around the globe

Fulltime

Specialist – QA Technical Support NPI

The Quality Assurance Technical Support Specialist NPI (New Product Introduction...

Location

Ireland , Dun Laoghaire

Salary:

Not provided

Amgen

Expiration Date

Until further notice

Requirements

University degree in a Science-related discipline
Minimum of 7 years’ relevant experience in the pharmaceutical or biotechnology industry as a Subject Matter Expert providing overall quality direction and oversight for key functional areas (i.e. Process Development, Validation, Manufacturing)
In-depth knowledge of applicable regulatory requirements and experience with regulatory inspections
Experience working in aseptic operations, relating to vial and syringe filling
Understanding of principles of Validation and New Product Introduction
Proven experience in Quality Systems (change control, non-conformance, corrective and preventative actions)
Strong organizational skills with the ability to manage tasks through to completion
Ability to work independently and remotely with minimum direct supervision
Strong critical thinking and problem-solving abilities
Independent, self-motivated, organized, able to multi-task in project environments and skilled in communication and collaboration

Job Responsibility

Provide overall quality direction and oversight for key functional areas (i.e. PD, Validation and Operations), ensuring that programs, policies and procedures are robust and in keeping with regulatory and Amgen expectations
Serve as the QA Lead for technology transfer and NPI activities for Aseptic product, providing quality oversight throughout process validation and product lifecycle introduction
Serve as the QA point of contact and decision-maker during validation execution, ensuring adherence to regulatory and internal standards
Lead QA review and approval of technology transfer and validation documentation including process descriptions, Validation Plans, protocols, validation reports, and risk assessments
Lead QA review and approval of SAP BOMs, MBRs and recipes
Partner cross-functionally with PD, Engineering, and Operations teams to ensure all NPI activities are compliant with regulatory and site quality requirements
Provide quality direction and input for Change Controls, CAPAs, and Deviation Investigations
Support inspection readiness and regulatory audits, representing QA for validation and NPI areas
Support a safe working environment by complying with all pertinent environmental health/safety practice, rules and regulations
Perform all activities in compliance with Amgen safety standards and SOPs

What we offer

Competitive salary structure
Generous Total Rewards Plan for staff and eligible dependents
Comprehensive employee benefits package, including retirement and savings plan with generous company contributions, group medical, life and disability insurance
Discretionary annual bonus program
Exceptional learning, development and career advancement opportunities

Fulltime

Global Business Development Manager

SP Industries Inc., an ATS Company is seeking an experienced Global Business Dev...

Location

United States , Warminster

Salary:

Not provided

ATS Automation Tooling Systems Inc.

Expiration Date

Until further notice

Requirements

7+ years of experience in pharmaceutical, biopharma, or life science capital equipment or system solutions, with a strong focus on aseptic processing and/or lyophilization
Proven track record of closing large, complex, multi million dollar pharmaceutical system deals with biopharma, biotech, diagnostics, or CDMO customers
Demonstrated ability to build and convert a global sales pipeline, including direct ownership of opportunity creation, deal progression, and bookings
Working knowledge of EU GMP Annex 1 and its impact on aseptic lyophilization system design, automation, contamination control, and customer requirements
Practical understanding of GAMP 5 principles, including computerized systems, controls, data integrity, and validation expectations in regulated environments
Experience selling or supporting fully integrated aseptic system solutions, including lyophilizers, automated loading/unloading, material handling, and associated system architectures
Ability to engage credibly with senior customer stakeholders across engineering, manufacturing, quality, and executive leadership
Experience operating in a player coach capacity, combining direct commercial responsibility with leadership of technical SMEs or solution specialists
Bachelor’s degree in engineering, life sciences, or a related technical discipline
Willingness to travel globally 30-50%

Job Responsibility

Own and drive global revenue growth across the aseptic and non aseptic lyophilization portfolio, with direct accountability for closing large, complex, high value pharmaceutical and biopharma capital equipment and system solutions
Define and execute the global commercial strategy for lyophilization systems, leveraging strong understanding of lyophilization cycle development, formulation considerations, CIP/SIP systems, and sterility assurance requirements to deliver differentiated, value based solutions
Serve as a senior commercial and technical authority across non-aseptic and aseptic filling and lyophilization, with strong working knowledge of EU GMP Annex 1, FDA expectations, cleanroom classifications, isolators/RABS, aseptic process simulations, validation strategies, and quality risk management
Lead the sale of fully integrated system solutions, including lyophilization, automated loading and unloading, material handling, controls, and supporting architectures—positioning SP as a total solution partner rather than a standalone equipment supplier
Apply practical knowledge of GAMP 5, computerized systems, and validation expectations to support compliant system design discussions, risk mitigation, and customer confidence throughout the sales process
Build, qualify, and actively manage a robust global pipeline, including ownership of forecasting, financial modeling, and business case development to support accurate revenue planning and strategic investment decisions
Personally engage senior customer stakeholders across engineering, manufacturing, quality, procurement, and executive leadership to influence complex buying decisions, support contract negotiations, and close strategic, multi site opportunities
Lead and develop a team of lyophilization commercial based subject matter experts, setting clear commercial priorities, driving accountability, and ensuring technical depth directly supports deal execution and customer success
Partner cross functionally with engineering, product management, project management, manufacturing, and service teams to shape commercially viable offerings, influence service strategies, and ensure end to end solutions meet customer, regulatory, and operational requirements
Maintain a strong understanding of biologics, vaccines, small molecule injectables, and sterile drug products, along with global outsourcing drivers, capacity constraints, and competitor capabilities impacting the lyophilization and aseptic processing market

What we offer

We provide a wide range of innovative and high-quality scientific products that improve people’s lives
We offer a robust health and welfare benefits package that includes Life, Health, Dental, Vision
We offer 401(K) including company match, Paid Time Off annually + Paid Holidays
You will enjoy career Advancement Opportunities and Tuition Assistance to help you achieve your goals and continue your career growth

Fulltime

Sterile Production Specialist

We deliver 4.3 billion healthcare solutions to people every year, thanks to the ...

Location

China , Beijing

Salary:

Not provided

Sanofi-Aventis Deutschland GmbH

Expiration Date

Until further notice

Requirements

At least a bachelor or above degree in pharmacy or biology disciplines with 0~2 years’ experience in quality or sterile area
Must be a committed 'Quality or Sterile' professional with knowledge of quality systems within the pharmaceutical or related industry
Thorough understanding of manufacturing processes and aseptic processes
Strong working knowledge of quality systems, regulatory requirements across multiple health authorities
Fluent English both in written and verbal
Good communication skills
Able to burden pressure
Brave to make decision

Job Responsibility

Assist dept. manager to coordination of Project, plan, Quality and engineering to organise production with right volume, right quality, right cost and on right time
Supervise production, human resources, facilities to ensure all activities comply with China GMP and Sanofi regulations
Keep continuously improvement in terms of safety, quality, cost, delivery, motivation and environment
Continuously improve the compliance level of sterile production, attend and promote SMS execution, Lean manufacturing
Organize, coordinate, track and implement of deviations, changes, validation, complaints and global standards gap analysis etc
To ensure the continuous process compliance improvement through the management of quality systems
To ensure the implement of quality policy/objectives of Sanofi and to ensure the quality compliance of sterile production operation
To ensure effectiveness of sterile production quality improvement programs/projects
Perform the job duties of the Inspection Process-Centric Unit
Responsible for the shift work of PCU production (morning, middle and night)

What we offer

wide range of health and wellbeing benefits including high-quality healthcare, prevention and wellness programs
at least 14 weeks’ gender-neutral parental leave

Fulltime

Sr Engineer

Independently provides and/or directs the characterization of process optimizati...

Location

United States , Juncos

Salary:

Not provided

Cencora

Expiration Date

Until further notice

Requirements

Doctorate OR Masters + 2 years of Engineering experience OR Bachelors in Engineering + 4 years of Engineering experience
GMP knowledge: Strong background in regulated environments with ability to apply GMP in manufacturing and validation
Validation expertise: Experience in drafting, executing, and approving validation
Time pressure filling: Hands-on experience with time pressure filling systems
Technical documentation: Experience in preparing, reviewing, and approving protocols, reports, and strategy presentations
Protocol development: Experienced in designing protocols for complex systems such as filling lines and aseptic processes
Communication skills: Strong written and verbal communication in English and Spanish
Collaboration: Proven experience working with QA, Manufacturing, and Engineering teams during critical activities
Working knowledge of pharmaceutical/biotech processes
Familiarity with validation processes

Job Responsibility

Complete complex or novel assignments requiring development of new and/or improved engineering techniques and procedures
Develop engineering policies and procedures that affect multiple organizational units
Supervise, coordinate and review work of a small staff of engineers, associates and/or technicians on an ongoing basis as well as on a project basis
Employ advanced engineering techniques and/or modifications of advanced techniques within area of engineering expertise
Apply knowledge of engineering principles and practices outside of area of discipline expertise to broad variety of assignments in related fields
Serves as a peer-recognized engineering technology specialist in at least one area, with overall responsibility for determining methodologies in that area
Application of mature engineering knowledge in planning and conducting projects
Develop technical solutions to complex problems requiring the regular use of ingenuity and creativity
Work with research, manufacturing, process development, utilities, facilities, quality assurance and validation departments in developing requirements and recommendations for large and/or highly complex system/facility modifications
Work with project managers to complete design and engineering projects within schedule, budget and quality constraints

What we offer

medical
dental
vision care
comprehensive suite of benefits that focus on the physical, emotional, financial, and social aspects of wellness
support for working families
backup dependent care
adoption assistance
infertility coverage
family building support
behavioral health solutions

Fulltime

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Aseptic Process Validation Specialist

Job Description

Job Responsibility

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