Validation Pharmaceuticals Job at Amaris Consulting (Wavre)

Validation Technician

The role of the "Validation Technician" with experience in performing Smoke Stud...

Location

Italy , Sabaudia

Salary:

Not provided

S.T.B. ValiTech S.r.l.

Expiration Date

Until further notice

Requirements

Diploma or degree in a technical/scientific field
At least one year of experience as a validation technician or in similar positions
Strong knowledge of regulations and quality standards (UNI EN ISO 14644-1, UNI EN ISO 14644-3, and EudraLex - Volume 4 Annex 1)
Proficiency in IT
Solid knowledge of videomaking
Familiarity with the following software: Blackmagic DaVinci Resolve and DJI Mimo
Experience with validation instrumentation – HVAC
Attention to detail and precision
Strong analytical and problem-solving skills
Good communication skills and a team-oriented attitude

Job Responsibility

Conduct Smoke Studies: Verify airflow patterns to ensure the proper movement of air within controlled contamination environments or installations
Video Recording and Editing: Plan, execute, and edit video recordings to document and analyze airflow and other validation activities
Qualification and Requalification of Pharmaceutical Systems: Perform qualification activities in compliance with current regulations and GMP (Good Manufacturing Practice Guidelines) requirements
Project Management: Coordinate and oversee testing, validation, and documentation phases, ensuring adherence to quality standards and deadlines
Collaboration with Various Operational Areas: Work closely with different teams to meet deadlines and ensure high-quality work while fostering a collaborative and efficient work environment
Validation Documentation Preparation: Draft comprehensive reports or protocols for qualification activities, ensuring traceability and compliance with current regulations
Compilation of Qualification and Requalification Reports: Compile reports and documentation by collecting data from qualification activities, including detailed documented evidence of tasks performed

What we offer

A stimulating growth path with leading clients in the pharmaceutical sector, providing opportunities for professional development in a dynamic and innovative environment

Qualification & Validation Specialist

Location

Italy , Milano

Salary:

Not provided

S.T.B. ValiTech S.r.l.

Expiration Date

Until further notice

Requirements

Degree in Engineering or Biotechnology
At least three years of previous experience in the role
Knowledge of industrial processes
Familiarity with computer systems
Proficiency in English
Willingness to travel to client sites and undertake business trips if necessary

Job Responsibility

Conduct validation activities for processes, machinery, equipment, computer systems, and instruments that have a qualitative impact on services, primarily in the chemical-pharmaceutical sector
Ensure quality standards and compliance with company policies and international regulations
Prepare technical and qualification documentation to provide support
Perform Risk Analysis

What we offer

A stimulating growth path with leading clients in the pharmaceutical sector

Process Validation Associate

This position reports to the Process Validation Manager and is responsible for m...

Location

Ireland , Cork

Salary:

Not provided

BioMarin Pharmaceutical

Expiration Date

Until further notice

Requirements

Bachelor of Arts/Sciences (BA/BS) degree, or higher, in a technical discipline (physical, engineering, chemical or biological sciences) is required
8+ years experience in a cGMP regulated manufacturing environment, with exhibited knowledge or proficiency in process validation, process sciences and change control
Organizational and management skills to participate in multi-discipline project groups
Ability to communicate with, present data to, and defend approaches in front of variable hierarchical audiences, scientific disciplines and health authority reviewers/inspectorate
Ability to comprehend scientific/technical information related to equipment, processes, and regulatory expectations
Understanding and demonstrated knowledge of regulatory requirements, guidelines, and recommendations for process validation expectations
Proficiency with technical writing expected
Proficiency with standard office software applications, including MS Word, MS Excel, MS Project, MS Power Point

Job Responsibility

Perform process validation activities related to BioMarin’s drug substance and drug products, through defined clinical and commercial stages
Execute (protocol generation, execution, and final package preparation) process validation activities related to the implementation of process changes and new processes
Assist with preparation of regulatory filings, with answering questions from regulatory agencies, and with presentations of materials during regulatory inspections/partner audits
Development and implementation of SOPs/Guideline documents with systemic procedural improvements
Determine methods and procedures on new assignments with supervision and in accordance with developed practices and procedures
May participate on sub-teams
Gain/maintain knowledge of industry standards and regulatory requirements for products developed and manufactured by BioMarin, validation techniques/approaches and systems utilized at BioMarin
Participate in multi-departmental meetings & project teams
Identifies and assists with implementation of improvements to Process Validation systems (department level impact)
Generation of process validation master plans, core validation master plans and additional supporting documentation

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

Validation Engineer III

The Validation Engineer III performs an array of well-defined validation activit...

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 6 years of Pharmaceutical industry experience or combination of work experience in Validation, QA, MFG, 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
Validation experience with the following is highly preferred: Thermal characterization, Vacuum physics, Heat and mass transfer, Formulation, Aseptic Filling and Lyophilization, Steam 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
assist with 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
Review commissioning, qualification and validation related system lifecycle documentation (user requirements, functional and design specifications, commissioning and qualification protocols)
Assist with 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
Assist management with mentoring and training of colleagues on policies and procedures including the requirements for validation
Validation representative on validation projects leading by example on projects
Develop and recommend science-based solutions with a focus on continuous improvement and compliance
Perform risk assessment and mitigation steps to achieve attainment and maintenance of a validated state of compliance for all equipment, utilities, processes, materials, and facilities
Coordinate and execute validation protocol activities with consistent and effective communication with affected departments

Fulltime

Young Professional Life Sciences

Sopra Steria offers tailored, end-to-end corporate technology and software solut...

Location

Belgium , Machelen

Salary:

Not provided

Sopra Steria

Expiration Date

Until further notice

Requirements

Educational Background: A degree in Life Sciences, Engineering, Pharmacy, or a related field
Knowledge of Validation and Qualification: Basic understanding of validation and qualification processes in the pharmaceutical industry is a plus
Technical Skills: Familiarity with Good Manufacturing Practices (GMP), regulatory guidelines, and industry standards
Analytical Skills: Ability to analyze data, identify trends, and draw meaningful conclusions
Problem-Solving: Skill in quickly resolving technical issues
Flexibility: Ability to adapt to changing environments and handle multiple tasks simultaneously
Stress Management: Capable of maintaining composure and effectiveness under pressure
Professionalism: Demonstrates a high level of professionalism in all interactions and tasks
Social Skills: Strong interpersonal skills, able to build and maintain positive relationships with colleagues and clients
Communication Skills: Excellent verbal and written communication skills, able to convey complex information clearly and concisely

Job Responsibility

Audits are conducted regularly to keep our standards high while adhering to strict quality control guidelines.

What we offer

Mobility options (including a company car)
insurance coverage
meal vouchers
eco-cheques
continuous learning opportunities through the Sopra Steria Academy
the opportunity to connect with colleagues at team events.

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

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

Validation Pharmaceuticals

Amaris Consulting

Location:
Belgium , Wavre

Category:
IT - Administration

Contract Type:
Not provided

Salary:

Job Description:

Job Responsibility:

Requirements:

Additional Information:

Job Posted:
March 04, 2026

Looking for more opportunities? Search for other job offers that match your skills and interests.

Similar Jobs for Validation Pharmaceuticals

Validation Technician

Qualification & Validation Specialist

Process Validation Associate

Validation Engineer IV

Validation Engineer III

Young Professional Life Sciences

Commissioning & Qualification Specialist

Process Validation Engineer

Validation Pharmaceuticals

Amaris Consulting

Location:Belgium , Wavre

Category:IT - Administration

Contract Type:Not provided

Salary:

Job Description:

Job Responsibility:

Requirements:

Additional Information:

Job Posted:March 04, 2026

Looking for more opportunities? Search for other job offers that match your skills and interests.

Similar Jobs for Validation Pharmaceuticals

Validation Technician

Qualification & Validation Specialist

Process Validation Associate

Validation Engineer IV

Validation Engineer III

Young Professional Life Sciences

Commissioning & Qualification Specialist

Process Validation Engineer

Location:
Belgium , Wavre

Category:
IT - Administration

Contract Type:
Not provided

Job Posted:
March 04, 2026