Qualification & Validation Engineer Pharmaceuticals Job at Amaris Consulting

Engineer, Validation

Being an Engineer at Baxter means you play a critical role in helping us achieve...

Location

United Kingdom , Stockport

Salary:

Not provided

Baxter

Expiration Date

Until further notice

Requirements

Scientific/Engineering Degree or equivalent qualification or the right experience within a validation role
Experience working with Hydrogen peroxide decontamination systems
In depth knowledge of a specific validation/engineering skill set i.e. temperature mapping, airflow and smoke visualization, Biological Indicator application and processing etc
Working knowledge of validation in a pharmaceutical/FMCG/medical devices environment preferably
Experience with Equipment/Process systems, Cleaning Validation, HVAC, QA, QC, or Cleanroom systems would be preferred
Approach tasks with a logical and practical perspective, and have a proactive approach to problem-solving
Display analytical thinking and innovative problem-solving abilities to successfully implement validation strategies
Self-motivated and driven to complete projects/tasks efficiently and effectively
Excellent teamwork skills to contribute effectively as a member of a diverse team and effectively communicate with individuals involved in the project

Job Responsibility

Ensure Site Validation Master Plan (SVMP) is strictly adhered to and that all validation activities are conducted in accordance with established protocols and procedures by executing validation work and a variety of equipment
Develop and implement validation documents and protocols for a variety of processes, equipment, facilities, and systems, with a particular emphasis on aseptic manufacturing
Work closely with the validation team and teams from various departments to assist with the implementation of new processes, products, and equipment at the site
Actively participate in the assessment, review, and approval of changes that may impact the validation status of our facilities, equipment, processes, and systems
Conduct thorough reviews of validation execution and equipment changes carried out by external contractors and internal project team members to ensure compliance with validation requirements
Take ownership of project management and execution for Capital Expenditure and Process Improvement Projects within the EMEA Validation project portfolio
Work with Quality Assurance to react to adhoc validation requirements

What we offer

Competitive total compensation package
Professional development opportunities
High importance placed on work life balance
Support for Parents
Continuing Education/Professional Development
Employee Heath & Well-Being Benefits
Paid Time Off
2 Days a Year to Volunteer

Fulltime

Validation Engineer

This is where your work makes a difference. At Baxter, we believe every person—r...

Location

United Kingdom , Stockport

Salary:

Not provided

Baxter

Expiration Date

Until further notice

Requirements

Scientific/Engineering Degree or equivalent qualification or the right experience within a validation role
Experience working with Hydrogen peroxide decontamination systems
In depth knowledge of a specific validation/engineering skill set i.e. temperature mapping, airflow and smoke visualization, Biological Indicator application and processing etc
Working knowledge of validation in a pharmaceutical/FMCG/medical devices environment preferably
Experience with Equipment/Process systems, Cleaning Validation, HVAC, QA, QC, or Cleanroom systems would be preferred
Logical and practical perspective
Proactive approach to problem-solving
Analytical thinking and innovative problem-solving abilities
Self-motivated and driven
Excellent teamwork skills

Job Responsibility

Ensure Site Validation Master Plan (SVMP) is strictly adhered to
Develop and implement validation documents and protocols for a variety of processes, equipment, facilities, and systems, with a particular emphasis on aseptic manufacturing
Work closely with the validation team and teams from various departments to assist with the implementation of new processes, products, and equipment at the site
Actively participate in the assessment, review, and approval of changes that may impact the validation status of our facilities, equipment, processes, and systems
Conduct thorough reviews of validation execution and equipment changes carried out by external contractors and internal project team members
Take ownership of project management and execution for Capital Expenditure and Process Improvement Projects within the EMEA Validation project portfolio
Work with Quality Assurance to react to adhoc validation requirements
Support validation activities across all UK Compounding sites

What we offer

Competitive total compensation package
Professional development opportunities
High importance placed on work life balance
Support for Parents
Continuing Education/ Professional Development
Employee Heath & Well-Being Benefits
Paid Time Off
2 Days a Year to Volunteer

Fulltime

Tech Validation Engineer

Our client are a specialist life science and healthcare company who work with a ...

Location

United Kingdom , Surrey

Salary:

45000.00 - 55000.00 GBP / Year

Network Scientific Recruitment

Expiration Date

Until further notice

Requirements

Scientific graduate and post-graduate qualifications in applied biology, biochemical/biomedical engineering
Understanding of SHE, ensuring compliance with regulatory and legislative requirements
Good understanding of research & pharmaceutical manufacturing regulations – GMP
Membership of relevant professional body
Familiar with Cross contamination control strategies & Quality Risk assessments
Experience in the validation of systems, equipment, and environment
Experience of project delivery
Highly organised and methodical with attention to detail
Able to maintain confidentiality of Company and clients’ information
Experience of working in a Clean Room or Laboratory environment

Job Responsibility

Lead Projects through all stages of design and development
Working with a project team of end users, designers and contractors to deliver high quality projects to timescale
Provide detailed consultancy to project stakeholders in line with regulatory and engineering standards for clean room design and construction
Execution of validation protocols at customer and vendor facilities
Generation of Quality Risk assessments
Lead project meetings including site visits
Generation of Validation Protocols for a full validation life cycle
Producing documentation specific to customer requirements: URS, VMP VP, RTM, DQ, IQ, OQ, & VSR
Responsible for the review, creation and maintenance of project progress reports including internal reports on project progress against budget and costs
Implement continuous improvement suggestions on process, procedures and documentation

Fulltime

Equipment Qualification Engineer

We are seeking a Qualification Engineer to support equipment qualification activ...

Location

Singapore , Singapore

Salary:

Not provided

Amaris Consulting

Expiration Date

Until further notice

Requirements

Bachelor’s degree in Engineering, Life Sciences, Pharmaceutical Sciences, Biotechnology, or related discipline
Minimum 2–3 years of experience in manufacturing equipment qualification within pharmaceutical, biotech, life sciences, or GMP-regulated manufacturing environments
Hands-on experience with equipment qualification activities, including IQ, OQ, PQ, validation documentation, and qualification lifecycle management
Good understanding of GMP, GDP, deviation management, change control, and data integrity principles
Ability to independently review, execute, and manage qualification protocols and related documentation
Strong communication and stakeholder management skills, with the ability to collaborate across cross-functional teams
Experience in CQV projects, technology transfer, or new facility/equipment setup will be an added advantage
Exposure to biologics, sterile manufacturing, API, or vaccine manufacturing environments is preferred
Experience supporting audits, inspections, or regulatory readiness activities is an advantage
Fluent in English, both written and spoken

Job Responsibility

Support qualification activities for manufacturing equipment used in GMP production
Execute and document IQ, OQ, and PQ activities
Prepare and review qualification protocols, test scripts, reports, and other GMP documents
Work closely with Engineering, Manufacturing, Quality, Validation, and Maintenance teams
Support equipment readiness checks, risk assessments, deviation handling, and qualification strategy discussions
Ensure all qualification work follows GMP, GDP, and data integrity requirements
Review and support approval of documents related to the equipment qualification and validation lifecycle

What we offer

An international community, bringing together 110+ different nationalities
An environment where trust has a central place: 70% of our key leaders started their careers at the first level of responsibilities
A robust training system with our internal Academy and 250+ available modules
A vibrant workplace that frequently gathers for internal events (afterworks, team buildings, etc.)

Fulltime

Qc equipment qualification engineer (microbiology / lab systems)

You will join our Life Sciences team in Singapore, supporting qualification and ...

Location

Singapore , Singapore

Salary:

Not provided

Amaris Consulting

Expiration Date

Until further notice

Requirements

Experience in pharmaceutical lab environments (QC / QA / Production), minimum 4 years
Experience in equipment qualification and validation
Academic background in Science, Biology, Microbiology, or related field
English proficiency

Job Responsibility

Drive and support QC equipment qualification activities in line with defined project timelines
Lead qualification lifecycle documentation and execution, including: URS, ERES, HLRA, Vendor & in-house IQ/OQ, PQ and Qualification Reports (QR)
Manage change control processes related to equipment qualification
Investigate and resolve qualification-related deviations and discrepancies
Collaborate with cross-functional stakeholders to ensure compliance and alignment
Ensure timely execution, review, and closure of qualification protocols
Support CAPEX-related activities within QC lab environments
Maintain compliance with HSE (Health, Safety, Environment) guidelines
Identify risks, propose mitigation plans, and participate in risk assessments
Contribute to continuous improvement initiatives in lab operations

What we offer

An international community bringing together 110+ different nationalities
An environment where trust has a central place: 70% of our key leaders started their careers at the first level of responsibilities
A robust training system with our internal Academy and 250+ available modules
A vibrant workplace that frequently gathers for internal events (afterworks, team buildings, etc.)

Fulltime

Validation Engineer

The Validation Engineer is responsible for executing and maintaining validation ...

Location

United States , Wichita

Salary:

Not provided

Fagron

Expiration Date

Until further notice

Requirements

Bachelor’s degree in Engineering or a scientific discipline (or equivalent experience)
2–5 years of validation experience in pharmaceutical, sterile manufacturing, or 503B compounding
Strong understanding of aseptic processing, cleanroom classification, equipment/utility systems (HVAC, WFI/PW, compressed gases), and sterile filling operations
Experience with cGMP documentation, risk assessments, change control, and CAPA systems
Proficient in technical writing, data analysis, and cross-functional collaboration
Ability to work in a fast-paced, highly regulated environment with strong attention to detail

Job Responsibility

Develop, execute, and maintain validation documents (IQ/OQ/PQ, PPQ, APS, CCIT, cleaning validation, equipment qualification, utility qualification)
Ensure validation activities comply with FDA 503B guidance, cGMPs (21 CFR Parts 210/211), and industry standards (USP <797>/<800>, ISPE, PDA)
Serve as validation SME for operations, engineering, quality, and new product introduction
Conduct and document validation-related investigations, including deviations, OOS, OOT, change controls, impact assessments, and CAPA root-cause analyses
Manage periodic review, revalidation, and continued process verification activities
Maintain calibration and preventative maintenance compliance for critical equipment and utilities
Support introduction of new equipment, closed systems, and aseptic technologies (e.g., single-use systems, isolators, automated filling systems)
Analyze validation data using appropriate statistical tools and prepare clear technical reports
Participate in regulatory inspections and defend validation lifecycle documentation
Stay current with regulatory expectations, emerging risks, and sterile compounding best practices

What we offer

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

Fulltime

Validation Engineer IV

The Validation Engineer IV performs an array of well-defined validation activiti...

Location

United States , Bedford

Salary:

Not provided

PCI Pharma Services

Expiration Date

Until further notice

Requirements

Bachelor’s degree in Engineering or related scientific discipline required with a minimum of eight (8) years of Pharmaceutical industry experience or combination of work experience in Validation, Quality, Production, or Engineering
Experience in pharmaceutical or biopharmaceutical environment in operations/engineering/manufacturing/quality environments
Combination of equipment qualification, process validation, or cleaning validation is acceptable
QA pharmaceutical experience also preferred
Direct Validation experience with pharmaceutical or biopharmaceutical processes including the development of strategies, master plans, protocols and reports
Validation experience with the following is highly preferred: Thermal characterization, Vacuum physics, Heat and mass transfer, Formulation, Aseptic Filling and Lyophilization. Sterilization
Experience in multiple regulatory inspections and knowledgeable in current industry standards and regulatory trends as they pertain to Validation of pharmaceutical or biopharmaceutical processes

Job Responsibility

Author validation plans
oversee and provide direction in the development of specifications for user requirements, functional requirements, and design requirements, trace matrices, validation summary reports and test protocols for installation, operation, performance of equipment, functional requirements, risk assessments, and IQ/OQ/PQ Protocols
Review and approve commissioning, qualification and validation related system lifecycle documentation (user requirements, functional and design specifications, commissioning and qualification protocols)
Provide direction on equipment/process change control development (equipment, utilities, facilities, and processes) used to develop and manufacture products in a cGMP environment
Work closely with other validation department personnel as well as cross-functionally with Manufacturing, Engineering, Critical Utilities, Quality Assurance, and project management to achieve all project deliverables
Perform a periodic review of systems to monitor the validation status of the system as well as write and develop validation SOPs
Help define validation strategies based on regulations, guidance documents, industry practice and experience
Assist management with mentoring and training of colleagues on policies and procedures including the requirements for validation
Team representative on validation projects leading by example on significant projects requiring complex technical solutions
Develop and recommend science-based solutions with a focus on continuous improvement and compliance

Fulltime

Process Validation Engineer

Reporting to the Senior Manager process Validation, the Process Validation Engin...

Location

United States , Bedford

Salary:

Not provided

PCI Pharma Services

Expiration Date

Until further notice

Requirements

Experience in pharmaceutical or biopharmaceutical environment in operations/engineering/manufacturing/quality environments
Proficient in the development and execution of PPQs
Review commissioning, qualification and validation related system lifecycle documentation
Combination of equipment qualification, process validation, or cleaning validation is acceptable
QA pharmaceutical experience also preferred
Validation experience with the following is highly preferred: Vacuum physics, Heat and mass transfer, Formulation, Aseptic Filling and Lyophilization, Steam Sterilization, data analysis and statistics
Engagement and knowhow with regulatory inspections and knowledgeable in current industry standards and regulatory trends as they pertain to Validation of pharmaceutical or biopharmaceutical processes
Bachelor of Science degree in Chemical Engineering, Biochemistry, Biology or related scientific discipline required with a minimum of 7 – 10 years of Pharmaceutical industry experience or combination of work experience in Validation, QA, MFG, MTS, Process Development or Engineering
Highly organized professional who is accustomed to working in a result oriented-focused, dynamic CMO environment
Professional and collaborative team player must have excellent interpersonal skills

Job Responsibility

Develop and support the detailed project plans and timelines for the execution of process validation activities
Prepare validation & change control documentation, including protocols, summary reports, etc.
Author Process Performance Qualification/ verification validation plans
Author and perform the technical review of deviations and planned deviations, change controls, perform process monitoring, perform activities for lot release
Participate in client and Regulatory Audits
Work on CAPA and QS with minimal oversight to achieve timely results
Assist with determining impact of change control on qualified process and aseptic operations
Work closely with other validation department personnel and cross-functionally with MTS, Manufacturing, Engineering, QC, Quality Assurance, and project management to achieve all project deliverables
Assist management with mentoring and training of colleagues on policies and procedures including the requirements for validation
Perform all functions associated with process validation support

Fulltime

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Qualification & Validation Engineer Pharmaceuticals

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