Verification and Validation Specialist Job at SpaceBridge Inc. (Montreal)

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

Invoice Verification Specialist

For our client, a well-established production company with a Shared Service Cent...

Location

Poland , Poznań

Salary:

8000.00 - 12000.00 PLN / Month

Devire

Expiration Date

Until further notice

Requirements

Experience in similar position (transport, forwarding, logistics administration) or finance operations (AP or invoicing)
Degree in Logistics, Finance, Business Administration, or a related field
Basic knowledge of transport processes across different modes
Ability to interpret transport tariffs and verify cost structures - well seen
Strong analytical skills and attention to detail
Experience working with ERP, TMS, or other financial/logistics systems
Very good command of English
Fluent German or French - required

Job Responsibility

Review and process transport and logistics invoices
Validate invoice details against agreed rates, contracts, and performed services
Code and allocate invoices in internal financial and transport management systems
Handle credit notes, payment reminders, and ensure accurate system postings
Investigate invoice discrepancies and coordinate corrections with carriers and internal stakeholders
Monitor transport-related costs and support cost transparency
Prepare reports and maintain documentation related to transport finance activities
Cooperate with logistics, procurement, and finance teams to ensure smooth invoice processing
Contribute to process improvements and support system-related initiatives

What we offer

Annual bonus
Loyalty bonus
Private medical care
Life insurance
Access to MyBenefit platform
Social fund benefits (e.g. holiday bonus)
Referral program
Access to well-being platform
Co-financing of trainings and courses

Fulltime

Requirement Verification & Validation Engineer

From concept development, to operational deployment and operations, until retire...

Location

India , Bangalore Area

Salary:

Not provided

Airbus

Expiration Date

Until further notice

Requirements

Identify the stakeholder for the M&T to be developed and capture their needs and expectations
Identify boundary of the M&T to be developed
Elicit and validate requirements whilst considering the complete system lifecycle
Design and define possible architectures, in collaboration with IS/IT specialists, considering the functions and other requirements (constraints)
Lead M&T modelling using appropriate modelling methods and tools
Lead analysis (e.g. performance)
Perform trade-off analysis in order to select the best solution fulfilling the requirements
Validate architecture
Define and manage interfaces requirements
Lead verification of the implementation and its interfaces

What we offer

Airbus is committed to achieving workforce diversity and creating an inclusive working environment. We welcome all applications irrespective of social and cultural background, age, gender, disability, sexual orientation or religious belief
At Airbus, we support you to work, connect and collaborate more easily and flexibly. Wherever possible, we foster flexible working arrangements to stimulate innovative thinking

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

Data Verification Specialist

As a Data Verification Specialist, you will be responsible for ensuring the accu...

Location

United States , Salt Lake City

Salary:

Not provided

MillenniumSoft Inc

Expiration Date

Until further notice

Requirements

Minimum of 2 years of experience in data entry or validation
Strong attention to detail and accuracy in data verification
Proficiency in MS Office (Word, Excel, Outlook)
Ability to research and resolve data discrepancies
Effective communication and collaboration in a cross-functional environment
High School Diploma or GED required

Job Responsibility

Maintain data integrity by reviewing verification reports for completeness and accuracy
Resolve discrepancies by researching and communicating with appropriate staff
Facilitate data governance by supporting assigned data owners as needed
Create and/or edit documentation as required
Work in a cross-functional environment with individuals from Marketing, Manufacturing, Packaging, Regulatory, and Quality teams
Support sustaining projects for chronic central venous catheters and implantable ports
Collaborate with team leaders and peers to plan and accomplish project goals

Fulltime

Senior QC Specialist (Method Validation & Technical Support)

The Senior QC Specialist (Method Validation & Technical Support) is responsible ...

Location

Singapore , Singapore

Salary:

Not provided

Amaris Consulting

Expiration Date

Until further notice

Requirements

Bachelor's Degree in Chemistry, Biochemistry, Biotechnology, Pharmaceutical Sciences, Life Sciences, or a related discipline
Minimum 5 years of experience in pharmaceutical or biopharmaceutical Quality Control, Analytical Development, or Technical Support functions within a GMP-regulated environment
Hands-on experience in analytical method validation, qualification, verification, transfer, equipment qualification (IQ/OQ/PQ), stability programs, and laboratory investigations (OOS/OOT, deviations, CAPAs, and change controls)
Strong knowledge of GMP requirements, analytical method lifecycle management, root cause analysis, GMP documentation, and global regulatory standards including FDA, USP, EP, ICH, PIC/S, and Data Integrity principles

Job Responsibility

Lead analytical method qualification, validation, verification, transfer, and lifecycle management for chemical and biological testing
Manage qualification of laboratory equipment, analytical instruments, and critical reagents, ensuring compliance throughout their lifecycle
Support introduction of new methods, technologies, materials, and equipment into QC operations
Coordinate and maintain QC stability programs, including data review and trend analysis
Lead investigations of deviations, non-conformances, invalid results, atypical results, and OOS events
perform root cause analysis and drive CAPA implementation
Monitor and implement regulatory and compendial updates to ensure ongoing compliance with GMP, FDA, USP, EP, and ICH requirements
Author, review, and approve GMP documentation including SOPs, protocols, reports, change controls, deviations, and CAPAs
Act as a technical SME, providing guidance, training, and knowledge transfer to QC testing teams
Support internal audits, regulatory inspections, and customer audits as the SME for assigned areas

Fulltime

Biospecimen Quality and Reconciliation Specialist

Location

India , Hyderabad

Salary:

Not provided

Amgen

Expiration Date

Until further notice

Requirements

Master’s degree & 3 years of experience with a strong Knowledge of clinical trials
Bachelor’s degree & 5 years of experience with a strong Knowledge of clinical trials
Prior experience in biospecimen operations and management in relation to clinical trials
Strong reconciliation and cross-system validation logic
Root cause analysis capability across vendor, site, and system issues
Knowledge of data base lock processes and regulatory documentation standards
High-detail orientation with investigative rigor
Understanding of consent-based restrictions and disposition workflows
Ability to operate independently as quality control layer
Risk sensitivity regarding blinded data and final transfer integrity

Job Responsibility

Accountable for cross-system reconciliation
Accountable for discrepancy queue management and pre-shipment resolution
Accountable for validation of results imports (automated and manual) including second-person verification controls
Accountable for data management interface validation prior to exports
Accountable for final results completeness verification and samples-not-resulted reporting
Accountable for database lock reconciliation and evidence package preparation
Accountable for Sample Data Change reporting cadence and Vendor Issue Log review
Accountable for disposition governance (withdrawals, consent not obtained, compromised samples)
Accountable for end-of-study operational checks and archive-ready documentation
Accountable for identifying systemic discrepancy trends and recommending corrective actions

Payroll and Benefit Specialist

The Payroll and Benefit Specialist supports the daily functions of the Human Res...

Location

United States , Chesapeake

Salary:

Not provided

Robert Half

Expiration Date

Until further notice

Requirements

3+ years of experience with ADP Payroll software and benefits
Excellent data entry skills and attention to detail
Prior experience in a corporate or manufacturing environment preferred
Excellent verbal and written communication skills, interpersonal skills, ethics, and cultural awareness
Resourceful, problem-solving aptitude and thorough knowledge of HR procedures and policies
Advanced MS Office, ADP software skills, and comfortable learning new technical systems as needed
Knowledge of HR federal laws and regulations
Ability to deliver effective results and meet deadlines
Strong organizational and time management skills

Job Responsibility

Oversees and maintains optimal function of HR systems, which may include installation, customization, development, maintenance, and upgrade to applications, systems, and modules. Collaborates with leadership to identify system improvements and enhancements
recommends and implements solutions
Serves as the main point of contact and liaison between HR and external HR systems’ vendors
Responsible for creating, managing, and maintaining employee personnel records and HRIS information, including processing all changes into employee records, preparing reports and statistical summaries from records, and providing verifications of employment and reference checks for active and terminated employees
Assists in managing the open enrollment process and administering employee benefit plans. Assists in working with the third-party administrator to resolve claim disputes with providers when necessary. Review and verify monthly provider bills
Responds to benefits inquiries from managers and employees on plan provisions, benefits enrollments, status changes, and other general inquiries in conjunction with the third-party administrator
Processes and administers all leave-of-absence requests and disability paperwork: medical, disability, and FMLA. Effectively assists with interpreting FMLA and ADA implications as they relate to leaves of absence/disabilities and reasonable accommodation requests
Manages bi-weekly payroll process, including bi-weekly updates to employee files, bonus pay, tracking vacation/sick pay, inputting exceptions, hourly employee validations, and benefit changes
Assists in maintaining compliance with federal, state, and local employment laws and regulations, and recommends best practices
reviews policies and practices to maintain compliance

What we offer

medical
vision
dental
life and disability insurance
401(k) plan

Select Country

Verification and Validation Specialist

Job Description

Job Responsibility

Requirements

Nice to have

Looking for more opportunities?