Aseptic Process Validation Specialist Job at Fagron (Wichita)

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

Process Engineering Specialist

This is a multi-faceted position providing process engineering support to the fa...

Location

United States , Sudbury

Salary:

100000.00 - 115000.00 USD / Year

Nestlé Purina

Expiration Date

Until further notice

Requirements

BS Degree in Chemical, Mechanical Engineering or a related field
3+ years of experience in process engineering & projects field
Experience in a food, dairy, pharmaceutical, etc manufacturing plant environment (preferably in infant formula and/or medical nutritional, dairy processing, spray drying process, or food / fluid products). Aseptic experience is a plus Preferred.
Ability to work flexible hours
Above average communication skills (written and oral)
Above average project management skills preferably in handling large scale projects (< $750,000)
Problem-solving skills
Ability to prioritize
Knowledge of Microsoft Word, Project and Excel required
SAP, AutoCAD experience is preferred

Job Responsibility

Provide process engineering support to the factory in capital project execution and process line support.
Responsible for project management, production line trouble shooting, administering budgeting, design, installation, qualification, and commissioning of new/modified process systems.
Assist Production and Quality Departments to resolve non-maintenance related production and quality issues.
Conduct training, maintain and update documentation relating to job.
Assist in training and mentoring of new engineering staff.
Follow up investigation using root cause analysis tools such as GSTD and/or DMAIC on process related issues
Provide resolution of process line quality deviations thru formal requests such as ODIR, process deviations, and NCR's
Investigation feasibility and scope analysis to determine potential operational improvements
Independently develop and design process systems for manufacturing of food products including liquid and powder
Conduct budget estimation, planning, and execution of projects.

What we offer

performance-based incentives
401k with company match
healthcare coverage
broad range of other benefits
physical, financial, and emotional wellbeing support
professional growth opportunities
dynamic career paths
robust development
opportunities to learn from talented colleagues around the globe

Fulltime

New

Cardiovascular Invasive Registered Nurse

The Cardiovascular Invasive Specialist RN (CVIS RN) performs within the scope of...

Location

United States , Titusville

Salary:

Not provided

Parrish Medical Center

Expiration Date

Until further notice

Requirements

Associates Degree in Nursing required
Registered Cardiovascular Invasive Specialist a plus
>2 years Previous Interventional Cardiology or Critical Care experience preferred
Must possess upon hire and maintain Current and valid State of Florida license as a Registered Nurse (RN)
License as a Registered Cardiovascular Invasive Specialist (RCIS) a plus
Current BLS through the American Heart Association required
Current ACLS through the American Heart Association or obtain within 3 months of hire

Job Responsibility

Participates in the achievement of strategic goals and objectives for the continued growth and success of assigned functional area(s)
Always provides excellent patient, family, visitor and internal customer experiences as measured by CMS, HCAHPS and/or other national best-practice service benchmarks
Performs within the scope of the RN license
Always achieves national best/leading practice standards for continuous quality improvement and patient safety as measured by CMS, Joint Commission, and other regulatory agencies pertinent to areas of responsibility (e.g. Society of Invasive Cardiovascular Professionals), holding self and others accountable for actions and outcomes. Annually meets all required department specific competencies
Always adheres to all Parrish Healthcare policies and procedures as well as regulations and codes established by federal, state and local government affecting professional practice and industry regulations. Actively participates in necessary certification, accreditation and audit procedures and ensures that required reports/documentation required are accurately prepared and submitted within established timeframes
Follows CDC isolation guidelines, appropriately uses PPE, and performs hand hygiene according to accepted standards of care. Identifies and prepares patient using aseptic technique as dictated by procedure ordered. Exhibits awareness of hazards which may endanger patients
Verifies orders and facilitates implementation, communicating with physician as needed. Proficiently performs coronary diagnostic and interventional procedures, non-ablation electrophysiology interventional procedures, and peripheral diagnostic and interventional procedures. Performs treatments and administers medications according to policy and training. Functions appropriately in clinical emergencies. Evaluates effectiveness of interventions and medications. Performs within the bounds of the applicable scope of practice for Cardiovascular Invasive Specialist. Facilitates timely patient throughput
Always services in a manner consistent with Parrish Healthcare's Healing Work Environment standards, assures an inclusive, collaborative team-based work environment, maintains skills and competencies, helps to navigate and orient new care partners as may be necessary. Learns and upgrades skills. Utilizes knowledge base to assist with orientation, training, and education of new personnel. Provides training for procedures within their competency
Takes call as rotated/assigned and responds (in hospital) per policy
Always serves as a good steward of resources

What we offer

Benefits Start on Day 1
Health, Dental and Vision Insurance
403(b) Retirement Program
Tuition Reimbursement/Educational Assistance
EAP, Flex Spending, Accident, Critical and Other Applicable Benefits
Annual Accrual of 152 Personal Leave Bank (PLB) Hours
Sign On Bonus Available

Fulltime

Packaging Specialist

The Associate Packaging Specialist supports the design, implementation, and cont...

Location

United States , Eau Claire

Salary:

Not provided

Nestle Health Science

Expiration Date

Until further notice

Requirements

Bachelor’s degree in Packaging Science/Engineering or related field
Packaging experience, preferably in food & beverage a plus
Knowledge of packaging specifications, materials, equipment, and systems
Understanding of regulatory compliance and food safety standards
Working knowledge of project lifecycle, contracts, and schedules
Proficiency in Microsoft Office (Excel, PowerPoint, Word, Project)
Preferred: SAP and CAPE palletization experience

Job Responsibility

Partner cross-functionally to manage material qualification and deliver results
Integrate packaging specifications into SAP, including spec and BOM creation
Serve as packaging SME supporting new product launches, productivity, quality, and cost improvements
Ensure safety, quality, and regulatory compliance, including DoC validation for food contact materials
Drive packaging programs to reduce cost, minimize damage, and create competitive advantage
Provide regular updates to leadership on project status, risks, budget, and direction
Support installation, commissioning, and layout changes for packaging equipment
Provide front-line factory support and drive knowledge transfer to build packaging capability and reduce recurring issues
Develop understanding of aseptic processes and packaging systems
Assess local waste streams to prioritize sustainable packaging solutions

What we offer

opportunities to learn from talented colleagues around the globe
benefits that support physical, financial, and emotional wellbeing
dynamic career paths
robust development

Fulltime

Associate Packaging Specialist

The Associate Packaging Specialist supports the design, implementation, and cont...

Location

United States , Eau Claire

Salary:

Not provided

Nestlé Purina

Expiration Date

Until further notice

Requirements

Bachelor’s degree in Packaging Science/Engineering or related field
Packaging experience, preferably in food & beverage a plus!
Knowledge of packaging specifications, materials, equipment, and systems
Understanding of regulatory compliance and food safety standards
Working knowledge of project lifecycle, contracts, and schedules
Proficiency in Microsoft Office (Excel, PowerPoint, Word, Project)
Preferred: SAP and CAPE palletization experience

Job Responsibility

Partner cross-functionally to manage material qualification and deliver results
Integrate packaging specifications into SAP, including spec and BOM creation
Serve as packaging SME supporting new product launches, productivity, quality, and cost improvements
Ensure safety, quality, and regulatory compliance, including DoC validation for food contact materials
Drive packaging programs to reduce cost, minimize damage, and create competitive advantage
Provide regular updates to leadership on project status, risks, budget, and direction
Support installation, commissioning, and layout changes for packaging equipment
Provide front-line factory support and drive knowledge transfer to build packaging capability and reduce recurring issues
Develop understanding of aseptic processes and packaging systems
Assess local waste streams to prioritize sustainable packaging solutions

Fulltime

Cell Therapy Manufacturing Specialist

We are seeking a motivated Cell Therapy Manufacturing Specialist to support manu...

Location

United States , South San Francisco

Salary:

40.00 - 45.00 USD / Hour

Solomon Page

Expiration Date

Until further notice

Requirements

Bachelor's degree or equivalent in a scientific or related discipline
1+ years of manufacturing experience in biotechnology, biopharmaceuticals, or another GMP-regulated environment
Experience following SOPs, batch records, and GMP documentation
Experience in cell therapy, biologics, or aseptic manufacturing is preferred
Strong organizational, communication, analytical, and problem-solving skills
Ability to work effectively in a fast-paced, team-oriented manufacturing environment

Job Responsibility

Execute manufacturing activities following SOPs, batch records, and GMP documentation
Support cell processing, reagent preparation, and sample handling in laboratory and manufacturing environments
Perform routine cleanroom operations, equipment setup, maintenance, and material management
Assist with process, equipment, and cleaning validation activities
Complete manufacturing documentation accurately and support deviations, CAPAs, and change controls as needed
Collaborate with Quality, Engineering, Validation, and other cross-functional teams to support manufacturing operations
Train and mentor team members on manufacturing procedures and aseptic techniques
Maintain compliance with cGMP, safety, and quality standards
Perform other manufacturing-related duties as assigned

What we offer

Medical
dental
401(k)
direct deposit
commuter benefits

Fulltime

Registered Nurse

Registered Nurse - TMCH Cancer Center Rudasill. Coordinates patient care plannin...

Location

United States , Tucson

Salary:

Not provided

Tucson Medical Center

Expiration Date

Until further notice

Requirements

Current RN licensure permitting work in the State of Arizona
Basic Life Support (BLS) certification
Additional certification may be required per department
Knowledge of direct patient care and critical care procedures and techniques, tools, and responses required to ensure optimal patient care
Knowledge of exam indicators, contraindications, and patient preparation
Skill in communicating in a clear and concise manner with staff involved in critical care, and physicians to ensure the proper care of patients
Skill in reading 12-lead EKG
Skill demonstrated in assigned disciplines such as EP, directly involved in patient care
Ability to read and interpret documents such as safety rules, operating and maintenance instructions, and procedure manuals
Ability to complete routine reports and correspondence

Job Responsibility

Coordinates patient care planning with other disciplines utilizing the principles of the nursing process and critical thinking skills in order to maintain patient safety and well-being
Provides direct patient care, evaluates outcomes, consults with other specialists as required and adjusts nursing care processes as indicated to ensure safe patient care
Writes or obtains initial nursing histories, assesses patients' conditions and develops individual care plans
maintains patient documentation
Receives and reviews preceding shift reports and floor nurse reports
makes complete rounds of all units, and notes patients' condition
Notifies appropriate physician regarding any unusual or unexpected events or problems requiring direct physician consultation
Works with other members of the interdisciplinary patient care team, implements and reinforces patient instructional needs with patient and family offering informational material and pointing out special areas of concern
Evaluates outcomes of patient care, consults with other specialists as needed and adjusts nursing care processes as necessary to ensure optimal patient care
Identifies and resolves workplace health and safety issues

RN Special Procedures Cath Lab

Coordinates patient care planning with other disciplines utilizing the principle...

Location

United States , Tucson

Salary:

Not provided

Tucson Medical Center

Expiration Date

Until further notice

Requirements

Graduation from a qualified, nationally-accredited nursing program
One year of nursing experience in an acute care setting preferred
Current RN licensure permitting work in the State of Arizona
Basic Life Support (BLS) certification required
Some departments will require advanced life support certification (ACLS and PALS)
Additional certification may be required for some specialties such as EP certification
For Hospice & Pediatrics areas, valid Arizona Fingerprint Clearance Card within 6 months of hire
For Mental Health only Crisis Prevention Instruction (CPI) required

Job Responsibility

Coordinates patient care planning with other disciplines utilizing the principles of the nursing process and critical thinking skills
Provides direct patient care, evaluates outcomes, consults with other specialists as required and adjusts nursing care processes as indicated to ensure safe patient care
Writes or obtains initial nursing histories, assesses patients' conditions and develops individual care plans
Receives and reviews preceding shift reports and floor nurse reports
Makes complete rounds of all units, and notes patients' condition
Notifies appropriate physician regarding any unusual or unexpected events or problems
Works with other members of the interdisciplinary patient care team
Implements and reinforces patient instructional needs with patient and family
Evaluates outcomes of patient care, consults with other specialists as needed
Identifies and resolves workplace health and safety issues

Fulltime

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Aseptic Process Validation Specialist

Job Description

Job Responsibility

Requirements

What we offer

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