Qualification & Validation Engineer Pharmaceuticals Job at Amaris Consulting

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

Life sciences Qualification engineer

As a qualification engineer you will work on projects in the life science indust...

Location

Belgium , Machelen

Salary:

Not provided

Sopra Steria

Expiration Date

Until further notice

Requirements

You hold a master's or bachelor degree in a scientific direction (engineering, chemistry, biochemistry, biotechnology, biomedical sciences, pharmaceutical sciences, ...) or equivalent by experience
You are experienced in working in a regulated environment, with developed document writing skills and an eye for quality
You demonstrate the consultancy mindset by being pro-active, taking ownership and showing commitment
You have a problem-solving mindset and a strong sense of responsibility
You want to learn and evolve
You can work independently as well as in a team
You speak Dutch and English fluently

Job Responsibility

Ensure that products, processes, systems, services, and documentation meet regional and global quality regulations and standards
Activities take place in a laboratory or production environment, or can relate to business technologies
Active in various areas such as computer system validation (CSV), lab instrument qualification, method validation, cleaning validation, engineering, quality assurance, business analysis, project management

What we offer

A variety of perks, such as mobility options (including a company car), insurance coverage, meal vouchers, eco-cheques, and more
Continuous learning opportunities through the Sopra Steria Academy to support your career development
The opportunity to connect with fellow Sopra Steria colleagues at various team events

Fulltime

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

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.

Principal, Packaging Engineering

Lead all aspects of packaging process development, qualification, validation, la...

Location

United States

Salary:

180000.00 - 240000.00 USD / Year

Loyal

Expiration Date

Until further notice

Requirements

Bachelor’s, Master’s, or PhD in Packaging Engineering, Chemical Engineering, Mechanical Engineering, Materials Science, or a related field
10+ years of experience in pharmaceutical or biopharmaceutical packaging engineering, with significant experience supporting commercial or late-stage OSD products
Deep expertise in small molecule, oral solid dosage packaging, including bottling, blister packaging, labeling, serialization, and container–closure systems
Proven success leading packaging process development, scale-up, qualification, and validation (IQ/OQ/PQ)
Strong experience with CDMO/CMO selection, technical transfer, and day-to-day management for packaging operations
Experience supporting commercial packaging operations, including launch readiness and ongoing supply
Demonstrated ability to author packaging sections of regulatory submissions (e.g., Module 3) and respond to packaging-related regulatory questions
Strong understanding of global packaging regulatory expectations (FDA, EMA, ICH), including CR/SF requirements and serialization/traceability standards
Experience with packaging component qualification, compatibility studies, and packaging-related stability requirements
Experience supporting or participating in pre-approval inspections (PAIs) related to packaging

Job Responsibility

Lead packaging process development, scale-up, and optimization for OSD drug products
Drive CDMO/CMO selection, including technical evaluations, audits, contracting, and governance for packaging operations
Develop and refine packaging processes, ensuring robustness, manufacturability, and compliance with regulatory and product requirements
Lead packaging qualification and validation (IQ/OQ/PQ) for launch and commercial readiness
Oversee packaging launch readiness, including artwork, labeling, serialization, child-resistant/senior-friendly requirements, packaging components, and distribution-related packaging needs
Establish and oversee commercial packaging operations, ensuring efficiency, compliance, and long-term supply continuity
Author and contribute to packaging-related sections of regulatory submissions (Module 3), including container closure system documentation, packaging process descriptions, and responses to regulatory queries
Support or participate in PAIs and other regulatory interactions related to packaging
Conduct and oversee packaging component qualification, compatibility studies, and packaging-related stability evaluations
Troubleshoot packaging issues, conduct root-cause investigations, and lead CAPAs

What we offer

Full-coverage health insurance — medical, dental and vision — for you and your dependents
$1,000 home office equipment stipend
$1,200/year learning budget for books, courses, etc.
$250/month wellness budget for gym, cleaners, spa, food, etc.
All 3-day weekends are turned into 4-day weekends
Unlimited vacation and paid holidays
Paw-ternity leave — adopt a dog and get a day off with your new family member
Competitive salary
Company equity options grant for new hires

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

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

Qualification & Validation Engineer Pharmaceuticals

Amaris Consulting

Location:
Belgium

Category:
-

Contract Type:
Not provided

Salary:

Job Description:

Job Responsibility:

Requirements:

Nice to have:

Additional Information:

Job Posted:
March 25, 2026

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