Qualification & Validation Specialist Job at S.T.B. ValiTech S.r.l. (Milano)

Qc Validation Specialist

We are looking for an experienced QC Validation Specialist to join a leading-edg...

Location

Singapore , Singapore

Salary:

9000.00 - 9500.00 SGD / Month

Randstad

Expiration Date

July 19, 2026

Requirements

Minimum of a Diploma or Bachelor's Degree in any Engineering field, Science, or a related technical discipline
Minimum of 5 years of hands-on experience in the qualification, requalification, relocation, or decommissioning of GMP laboratory equipment within the pharmaceutical or biopharmaceutical industry
Demonstrated, deep familiarity with analytical and laboratory instrumentation (e.g., Chromatography systems, spectrometers, counters, and controlled temperature units)
Robust understanding of GMP regulations, data integrity principles, and data lifecycle management

Job Responsibility

Execute end-to-end qualification (IQ/OQ/PQ), requalification, relocation, and decommissioning/retirement protocols for a wide range of QC laboratory analytical and micro equipment
Lead validation activities for systems including, but not limited to: HPLC, CE, UV-Vis Spectrometers, TOC Analyzers, Microplate Readers, Liquid Particle Counters, Analytical Balances, Incubators, and Particle Counters
Author, review, and execute validation master plans, protocols, deviations, and final summary reports in strict accordance with Good Manufacturing Practices (GMP)
Collaborate closely with QC Lab Analysts, Quality Assurance, and external vendors to minimize lab downtime during relocation and equipment retirement
Ensure instrument software, audit trails, and historical data are securely backed up and compliant with data integrity standards prior to equipment decommissioning

What we offer

SGD 250 Monthly Transport Allowance

Fulltime

Senior Quality Validation Specialist

Leading Global Pharmaceutical Multinational (MNC) is seeking a high-caliber Seni...

Location

Singapore , Singapore

Salary:

7000.00 - 9500.00 SGD / Month

Randstad

Expiration Date

July 19, 2026

Requirements

Minimum of 5 years of robust experience in a highly regulated pharmaceutical or biopharmaceutical manufacturing environment
At least 3 years of dedicated track record in successfully delivering validated laboratory systems qualifications
Strong hands-on experience and structural understanding of automated systems and computerized system validation (CSV) frameworks supporting lab or plant operations
Proven ability to work independently, influence cross-functional teams, and deliver results under tight project schedules
Hands-on experience and understanding of automated systems supporting pharmaceutical manufacturing, and/or laboratory operations
A Bachelor’s Degree or Diploma in a relevant technical or scientific discipline

Job Responsibility

Lead and oversee the preparation, review, and execution of validation lifecycle documentation (URS, DQ, IQ, OQ, PQ) for complex automated and computerized systems
Provide deep, hands-on expertise in the qualification of automated systems supporting manufacturing (e.g., PLC/SCADA, MES) and/or advanced laboratory operations (e.g., LIMS, Empower, instrument software integrations)
Ensure all validation activities strictly comply with global Good Manufacturing Practices (GMP), GAMP 5 methodologies, and stringent Data Integrity standards (21 CFR Part 11 / ALCOA+ principles)
Partner closely with Automation, IT, Quality Control, and QA teams to manage project timelines. Drive risk assessments (FMEA) and proactively mitigate validation delays
Provide senior-level oversight for validation deviations. Lead thorough root-cause investigations and implement robust Corrective and Preventive Actions (CAPA)

What we offer

SGD 250 Monthly Transport Allowance

Fulltime

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

Cleaning Validation Specialist

We are seeking a Cleaning Validation Engineer to lead and support cleaning valid...

Location

Singapore , Singapore

Salary:

Not provided

Amaris Consulting

Expiration Date

Until further notice

Requirements

Bachelor's degree in Engineering, Life Sciences, Pharmaceutical Sciences, or related field
Strong experience in cleaning validation or cleaning qualification within pharmaceutical, biotech, or GMP-regulated manufacturing environments
Solid understanding of cleaning validation principles, strategies, and regulatory expectations
Experience preparing and reviewing cleaning validation protocols, reports, risk assessments, and related GMP documentation
Good knowledge of GMP manufacturing equipment, cleaning processes, and sampling methods such as swab and rinse sampling
Familiarity with cleaning validation lifecycle management, revalidation activities, and process improvement initiatives
Exposure to health-based exposure limits, MACO, PDE/ADE calculations, or worst-case product selection is preferred
Ability to work independently and provide technical guidance on cleaning validation topics
Experience supporting audits, inspections, remediation projects, or acting as a Validation Lead/SME is an advantage
Exposure to sterile manufacturing, biologics, vaccine, API, or pharmaceutical manufacturing environments is preferred

Job Responsibility

Lead and support cleaning validation / cleaning qualification activities for manufacturing equipment and processes
Develop, review, and execute cleaning validation strategies, protocols, and reports
Lead technical discussions related to cleaning approach, acceptance criteria, sampling strategy, and validation rationale
Review cleaning procedures, cleaning methods, and equipment cleaning practices
Support risk assessments related to product carryover, cross-contamination, equipment design, and cleaning effectiveness
Define or review acceptance limits, worst-case product selection, residue limits, and sampling points
Collaborate closely with Manufacturing, QA, Validation, Engineering, and QC teams
Ensure documentation is aligned with GMP, GDP, data integrity, and site quality requirements
Identify gaps in current cleaning validation practices and recommend practical improvement actions
Support audit readiness and respond to cleaning validation-related questions during inspections or internal reviews

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.)
Opportunity to turn ideas into action and make a tangible impact on sustainability
WeCare Together program to design and lead projects that create real social or environmental impact

Fulltime

Quality Validation Specialist

The new employee, reporting directly to the Quality Validation Coordinator, will...

Location

Italy , Pomezia

Salary:

Not provided

Alfasigma

Expiration Date

Until further notice

Requirements

Master’s degree in industrial chemistry, Pharmaceutical Chemistry and Technology (CTF), Chemistry, Chemical Engineering, Biomedical Engineering or Automation Engineering
Knowledge of the main ALCOA+ principles
Knowledge of the key Data Integrity guidelines
Strong interpersonal and communication skills
Result‑oriented mindset with strong problem‑solving skills
Good organizational skills
Good knowledge of GMP Quality Systems
Minimum of 5 years working within pharmaceutical manufacturing
Strong command of the English & Italian languages, technical writing skills are a must

Job Responsibility

Ensure the implementation and ongoing maintenance of ALCOA / ALCOA+ principles throughout the entire GMP data lifecycle
Support and/or perform Data Integrity Risk Assessments (DIRA) on processes, equipment, and computerized systems
Evaluate and approve data governance controls, including access management, audit trails, backup, archiving, and data lifecycle management
Manage data integrity deviations and incidents, including the definition and follow‑up of CAPAs
Support regulatory inspections and audits as Data Integrity Subject Matter Expert (SME)
Perform critical QA review and approval of equipment qualification documentation, including: User Requirement Specification (URS) Installation Qualification (IQ) Operational Qualification (OQ) Performance Qualification (PQ) Qualification reports and requirements traceability Periodic requalification activities
Ensure documentation compliance with GMP requirements, Annex 11, and GAMP 5
Assess GMP impacts of change controls related to equipment and systems
Participate in Factory Acceptance Tests (FAT) and Site Acceptance Tests (SAT)
Collaborate with other Site Departments in order to achieve the goal of the company’s projects

What we offer

Competitive salary
Comprehensive benefits
Extensive opportunities for professional growth and development

Fulltime

Senior Validation Specialist

The role of the Senior Validation Specialist is to implement and execute tasks r...

Location

Ireland , Stamullen, Co. Meath

Salary:

Not provided

PCI Pharma Services

Expiration Date

Until further notice

Requirements

Min 3 years' Quality experience
Min 2 years' Validation experience
Equipment Qualification (IQ, OQ, PQ) – Hands on experience in protocol generations, execution, completion
Process Validation (PV) experience
New Product Introduction (NPI) - Generation, execution and close out of validation projects
Communication Customer/Internal stake holders/Suppliers
Experience with deviation, CAPA processes
Flexible and able to manage multiple priorities simultaneously
Periodic reviews

Job Responsibility

Support the validation effort for all Strategic Projects on site
Ensure all validation activities on site relating to Facility, Equipment and Processes meet the expectations of clients but more specifically meet regulatory requirements (HPRA/ FDA)
Prepare, review and or approval of qualification and/or validation documentation (VMPs, specifications, protocols, reports etc.) in relation to instrument, equipment, facilities (including cold stores), utilities, automated systems, manufacturing processes and cleaning processes including FAT, SAT, IQ, OQ, PQ phases in conjunction with program Quality representation
Drive solutions, in conjunction with the appropriate department, to ensure customer related validation problems are communicated and corrective actions are in place and closed in a timely manner
Thorough investigation of Quality and Validation issues using Root Cause Analysis methodology and implementation of robust corrective and preventative actions to prevent recurrence
Support change controls as required
Execute validation activities, with minimal supervision, in conjunction with Technical, Production and Engineering functions
Ensure the strict implementation of validation procedures plus the timely and accurate completion of all validation documentation
Supports the coordination & scheduling of packaging validation activities in alignment with planning & packaging functions
Perform Periodic reviews, revalidations, and continued process verifications on a scheduled basis

Fulltime

Autoclave Performance Qualification Specialist

We are seeking a skilled Autoclave Performance Qualification Specialist to join ...

Location

United States , Juncos

Salary:

Not provided

Cencora

Expiration Date

Until further notice

Requirements

Bachelor's degree in Engineering, Life Sciences, or a related field (Master's preferred)
3+ years of experience in pharmaceutical or biotech validation, with a focus on autoclave or sterilization equipment
Proficiency in validation software (e.g., Kaye Validator, Ellab), statistical tools (e.g., Minitab), and regulatory standards
Strong analytical skills, attention to detail, and ability to work in a fast-paced, regulated environment
Excellent communication and teamwork abilities

Job Responsibility

Design, execute, and document performance qualification protocols for autoclave systems, including cycle development, validation, and re-qualification
Perform risk assessments, data analysis, and statistical evaluations to verify autoclave efficacy (e.g., heat distribution, penetration, and lethality)
Collaborate with cross-functional teams (Engineering, Validation, and Operations) to resolve equipment issues and implement improvements
Maintain detailed records, generate reports, and ensure compliance with regulatory requirements (e.g., 21 CFR Part 11, Annex 1)
Train staff on autoclave operations and participate in audits and inspections
Stay updated on industry best practices and emerging technologies in sterilization validation

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
paid parental leave
paid caregiver leave
training programs
professional development resources

Fulltime

Commissioning and Qualification Specialist

We are looking for a skilled Commissioning and Qualification Specialist to join ...

Location

Belgium

Salary:

Not provided

Amaris Consulting

Expiration Date

Until further notice

Requirements

Bachelor’s degree in Engineering, Life Sciences, or a related field
Minimum of 4 years of experience in the pharmaceutical sector, specifically in commissioning and qualification of HVAC systems and clean rooms
Strong knowledge of regulatory requirements (FDA, EMA, etc.) and industry standards (GMP, ISO)
Excellent problem-solving skills and attention to detail
Strong communication and interpersonal skills, with the ability to work collaboratively in a team environment

Job Responsibility

Lead the commissioning and qualification processes for HVAC systems and clean rooms in compliance with industry regulations and company standards
Develop and execute validation protocols, including IQ, OQ, and PQ documentation
Collaborate with engineering, operations, and quality assurance teams to ensure seamless project execution
Conduct risk assessments and provide recommendations for improvements in systems and processes
Maintain accurate records and documentation of all commissioning and qualification activities
Stay updated on industry trends, regulations, and best practices related to commissioning and qualification

What we offer

Competitive salary and performance-based incentives
Comprehensive benefits package, including health insurance, retirement plans, and paid time off
Opportunities for professional development and career advancement
A collaborative and innovative work environment

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