CrawlJobs Logo

CQV Coordinator Pharmaceuticals

amaris.com Logo

Amaris Consulting

Location Icon

Location:
Belgium , Beerse

Category Icon
Category:
-

Job Type Icon

Contract Type:
Not provided

Salary Icon

Salary:

Not provided
Save Job
Save Icon
Apply Position

Job Description:

We are looking for a CQV manager to provide documented evidence that all equipment and utilities used in IM SC are qualified and remain in a state of control, ensuring processes and products meet regulatory and business specifications.

Job Responsibility:

  • Coordinate qualification activities for assigned projects/changes/modifications
  • Own technical content of Equipment Qualification files (URS, SRS, SIA, CARA, DQ, QP, IQ, OQ, PQ, QSO)
  • Act as Technical Owner within the organization
  • Review and approve qualification documents in KNEAT (paperless system)
  • Lead core team/planning meetings for assigned projects
  • Maintain Kanban cards for work overview
  • Manage test planning, materials, and resources with cross-functional teams
  • Ensure timely, qualitative execution of qualification activities
  • Ensure GMP compliance throughout qualification lifecycle
  • Identify gaps in procedures/files and propose improvements
  • Initiate non-conformance reports in COMET
  • Support internal/external inspections and maintain Validation Master Plans
  • Coach qualification engineers on technical standards
  • Provide onboarding training for new team members
  • Serve as backup SME for colleagues during absences

Requirements:

  • 5+ years in pharmaceutical GMP environment
  • Technical Expertise: Aseptic/sterile equipment and processes
  • Education: Technical-scientific degree preferred
  • Languages: Fluency in English is mandatory and Dutch is a strong advantage
  • Systems: KNEAT experience preferred
What we offer:
  • Rapid growth: Amaris has doubled its workforce in Belgium in two years, providing numerous growth opportunities for employees
  • Prestigious projects: Candidates will work with renowned clients in the pharmaceutical, biotechnology, and European institutions sectors on impactful missions
  • International environment: An agile and dynamic structure promotes intrapreneurship and meritocracy, with international exposure at the heart of Europe

Additional Information:

Job Posted:
March 04, 2026

Employment Type:
Fulltime
Icon
Amaris Consulting - All Job Offers
Job Link Share:
Copy Link Icon
Facebook Icon Twitter Icon LinkedIn Icon

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

Briefcase Icon

Similar Jobs for CQV Coordinator Pharmaceuticals

New

GMP Engineering Compliance Specialist

We are seeking an Engineering Compliance Specialist to support engineering syste...
Location
Location
Singapore , Singapore
Salary
Salary:
Not provided
amaris.com Logo
Amaris Consulting
Expiration Date
Until further notice
Flip Icon
Requirements
Requirements
  • Bachelor's degree in Engineering, Life Sciences, or related field
  • Experience in pharmaceutical, biotech, life sciences, or GMP-regulated manufacturing environments
  • Hands-on or review experience in engineering system checks, asset review, maintenance risk assessments, or calibration activities
  • Good understanding of GMP documentation practices and engineering compliance requirements
  • Ability to review engineering records, maintenance records, calibration documentation, and related technical documents
  • Strong attention to detail, structured working approach, and ability to coordinate effectively with cross-functional stakeholders
  • Experience in pharmaceutical manufacturing, biologics, sterile manufacturing, or API production is an advantage
  • Exposure to validation, qualification, CQV, or GMP project support activities is preferred
  • Familiarity with equipment lifecycle management, preventive maintenance, calibration programs, or asset management systems is an advantage
  • Experience supporting audit readiness or GMP documentation remediation activities is preferred
Job Responsibility
Job Responsibility
  • Support engineering system checks within a GMP manufacturing environment
  • Review asset records and equipment status to ensure proper documentation and compliance
  • Conduct or support maintenance risk assessments for manufacturing and engineering systems
  • Review calibration status, calibration records, and related documentation
  • Assess whether engineering activities may impact GMP compliance, product quality, or equipment readiness
  • Collaborate closely with Engineering, Quality, Maintenance, Validation, and Manufacturing teams
  • Review and support preparation of GMP documentation, reports, checklists, and compliance records
  • Identify documentation gaps and support follow-up actions or remediation activities
  • Ensure all work is performed in line with GMP, GDP, and site quality requirements
What we offer
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.)
  • At Mantu, sustainability is part of everything we do. You’ll have the opportunity to turn your ideas into action and make a tangible impact
  • Through our WeCare Together program, you’ll be empowered to design and lead projects that create real social or environmental impact, with the company’s full support
  • Fulltime
Read More
Arrow Right

Clean Utilities & CIP Automation Coordinator

Piper Companies is seeking a Clean Utilities & CIP Automation Coordinator to sup...
Location
Location
United States , Holly Springs
Salary
Salary:
155000.00 - 175000.00 USD / Year
pipercompanies.com Logo
Piper Companies
Expiration Date
Until further notice
Flip Icon
Requirements
Requirements
  • 5+ years of experience supporting automation or controls within a cGMP pharmaceutical or biotech manufacturing environment
  • Hands-on experience with Emerson DeltaV DCS
  • familiarity with PLC-supported utilities systems (Siemens or Rockwell) is preferred
  • Strong understanding of automation change control, commissioning, and validation processes in FDA-regulated facilities
  • Working knowledge of Kneat validation software with the ability to review and support document generation
  • Proven ability to coordinate across technical and non-technical teams, communicate clearly under pressure, and manage shifting priorities on-site
Job Responsibility
Job Responsibility
  • Act as the primary on-site coordination point for clean utilities and CIP automation activities, aligning priorities across automation, utilities, CQV, and manufacturing teams
  • Drive automation deliverables through startup phases including commissioning, qualification, performance testing, and early engineering and production runs
  • Oversee system integrator execution for DeltaV-based utilities systems, ensuring software development, testing, and change execution align with operational needs
  • Review, contribute to, and approve lifecycle and validation documentation, including Kneat-based commissioning protocols, OQs, and automation change assessments
  • Communicate status, risks, and escalations effectively across cross-functional workstreams and participate in daily and tiered project meetings
What we offer
What we offer
  • Medical, Dental, Vision, sick leave if required by law, and 401K
  • Fulltime
Read More
Arrow Right
New

Vie Pharmaceuticals

We are offering international volunteer positions (VIE) for talented engineers a...
Location
Location
Belgium , Brussels
Salary
Salary:
Not provided
amaris.com Logo
Amaris Consulting
Expiration Date
Until further notice
Flip Icon
Requirements
Requirements
  • Bachelor's or Master's degree in Chemical, Mechanical, Electrical, Automation, Environmental Engineering, or related field
  • Strong interest in the pharmaceutical, biotech, or life sciences industry
  • Basic understanding of GMP, validation, or industrial safety (training or internship experience accepted)
  • Technical aptitude and problem-solving mindset
  • Fluency in English and French or Dutch
  • Adaptability, teamwork, and willingness to work in a regulated environment
Job Responsibility
Job Responsibility
  • Support the execution of CQV protocols (IQ/OQ/PQ) for equipment, utilities, and processes
  • Assist in process validation (PPQ, CPV) and technical transfer activities
  • Collaborate with engineering and quality teams to ensure compliance with GMP and regulatory standards
  • Contribute to documentation (protocols, reports, change controls)
  • Provide technical support to manufacturing units to ensure operational efficiency
  • Investigate deviations, support CAPA implementation, and participate in internal audits
  • Ensure adherence to GMP, safety, and quality standards across production lines
  • Assist in continuous improvement projects (Lean, Six Sigma)
  • Implement and monitor EHS programs in line with local and international regulations
  • Conduct risk assessments, safety audits, and incident investigations
What we offer
What we offer
  • International experience under the VIE program
  • Monthly allowance
  • Health insurance
  • Travel coverage
  • Return ticket at the end of the mission
  • Mentorship and professional development within a global organization
  • Opportunity to work on high-impact projects in a cutting-edge pharmaceutical environment
  • Potential for future career opportunities within the group
Read More
Arrow Right

Engineering Manager – F&E Readiness

Amgen Dun Laoghaire (ADL) is developing a next-generation, technologically advan...
Location
Location
Ireland , Dun Laoghaire
Salary
Salary:
Not provided
amgen.com Logo
Amgen
Expiration Date
Until further notice
Flip Icon
Requirements
Requirements
  • Bachelor’s degree in Engineering (Mechanical, Electrical, Chemical, or related discipline)
  • Experience (typically 5+ years) in engineering roles within a cGMP biopharmaceutical manufacturing environment
  • Experience in developing strategies for new product introduction and new technology deployment
  • Strong knowledge of, Equipment lifecycle management, Maintenance and reliability systems, GMP compliance, validation, and regulatory expectations
  • Proven ability to lead, build and develop teams, including working cross-functionally and managing complex stakeholder environments
  • Project management, problem-solving and decision-making capability
  • Excellent communication and technical writing skills
Job Responsibility
Job Responsibility
  • Act as the F&E representative within the capital project team, ensuring site requirements are embedded in facility and equipment design
  • Provide technical input and review of design deliverables (layouts, P&IDs, URS, specifications, automation strategies, maintenance concepts)
  • Ensure alignment with Amgen global standards, corporate blueprints and site operational requirements
  • Partner with Global Engineering, CQV, Automation, Quality and Operations to ensure a fully integrated and operable facility design
  • Identify and mitigate operability, maintainability and reliability risks early
  • Define and develop the F&E readiness strategy, including: Maintenance strategy and asset lifecycle plans
  • Spare parts and criticality assessments
  • Reliability and performance frameworks (OEE, predictive maintenance)
  • Establish systems to ensure equipment reliability and lifecycle ownership aligned with site expectations
  • Drive implementation of predictive and preventative maintenance philosophies from design through operation
What we offer
What we offer
  • competitive salary
  • comprehensive Total Rewards Plan including health, financial and career development benefits
Read More
Arrow Right
New

Receptionist

We are looking for a personable and dependable Receptionist to support a governm...
Location
Location
United States , Philadelphia
Salary
Salary:
Not provided
https://www.roberthalf.com Logo
Robert Half
Expiration Date
Until further notice
Flip Icon
Requirements
Requirements
  • At least 1+ years of receptionist or front desk experience in an office setting
  • Strong customer service skills with the ability to make visitors and callers feel welcome
  • Proven ability to communicate effectively with diverse groups of people
  • Comfortable handling clerical tasks, including data entry, file organization, and email communication
  • Proficiency with Microsoft Office Suite, including Word, Excel, and Outlook
  • Ability to remain patient, attentive, and solution-oriented in challenging situations
  • Friendly interpersonal style with dependable judgment and a positive attitude
Job Responsibility
Job Responsibility
  • Welcome visitors, members, and staff in a courteous manner and guide them to the appropriate person or department
  • Manage front desk activity by answering a multi-line phone system, responding to routine inquiries, and directing calls accurately
  • Provide administrative assistance such as data entry, document preparation, email correspondence, and general clerical support
  • Coordinate communication between internal departments to ensure questions and requests are handled efficiently
  • Maintain organized files, records, and front office materials to support daily operations
  • Use Microsoft Word, Excel, and Outlook to complete routine office tasks and prepare basic correspondence
  • Help schedule appointments and support calendar-related needs as requested
  • Foster a positive and respectful environment when assisting individuals from a wide range of backgrounds
What we offer
What we offer
  • medical
  • vision
  • dental
  • life and disability insurance
  • 401(k) plan
  • Parttime
Read More
Arrow Right
New

Pc Technician

We are looking for a PC Technician to support end users during a Long-term Contr...
Location
Location
United States , Feasterville-Trevose
Salary
Salary:
Not provided
https://www.roberthalf.com Logo
Robert Half
Expiration Date
Until further notice
Flip Icon
Requirements
Requirements
  • Hands-on experience supporting desktop or laptop deployments in an enterprise environment
  • Familiarity with PC hardware, associated peripherals, and general computer troubleshooting
  • Ability to perform operating system installations, device wiping, and workstation reimaging
  • Experience assisting end users with account access, authentication tools, and cloud-based file synchronization
  • Working knowledge of hardware platforms such as Dell technologies and Apple devices
  • Comfortable following structured processes and completing repetitive technical tasks with accuracy
  • Strong communication skills with the ability to assist users in person during onsite support activities
Job Responsibility
Job Responsibility
  • Guide users through OneDrive synchronization and help configure secure access using Microsoft Authenticator
  • Support the transition of browser-based user information by moving necessary data and settings into Microsoft Edge
  • Reimage workstations and perform clean operating system installations on assigned computers after initial site activities are completed
  • Assist employees with signing in to newly prepared devices and confirm successful access to their accounts
  • Move user files from cloud storage into the required organizational environment and verify availability of work-related resources
  • Test core applications and services after setup to ensure each user can perform daily job functions without issue
  • Document problems encountered during deployment activities and escalate unresolved user or device issues to the appropriate support team
  • Handle hardware-related tasks such as workstation setup, peripheral connections, and basic cabling as needed at each location
What we offer
What we offer
  • Medical, vision, dental, and life and disability insurance
  • 401(k) plan
Read More
Arrow Right
New

PC Technician

We are looking for a PC Technician to support a large-scale endpoint deployment ...
Location
Location
United States , Feasterville Trevose
Salary
Salary:
Not provided
https://www.roberthalf.com Logo
Robert Half
Expiration Date
Until further notice
Flip Icon
Requirements
Requirements
  • Experience supporting desktop or laptop deployments in a hands-on technical environment
  • Working knowledge of computer hardware, peripheral setup, and general associated hardware troubleshooting
  • Familiarity with operating system installation, device reimaging, and end-user workstation configuration
  • Ability to support cable connections and basic workstation setup as part of device deployment activities
  • Experience working with Dell Technologies systems and Apple devices in a support capacity
  • Comfortable assisting users with authentication tools, cloud-based file access, and browser or profile-related data migration
  • Strong communication skills and the ability to follow documented processes with accuracy and consistency
Job Responsibility
Job Responsibility
  • Prepare users for device deployment by confirming cloud file synchronization, setting up secure authentication access, and transferring browser-based work data to the required platform
  • Reimage workstation hardware and install a clean operating system to align devices with current technical standards
  • Guide employees through first-time sign-in on newly deployed computers and help them regain access to their work environment
  • Move required files from cloud storage into the appropriate organizational environment and verify successful access to business applications and services
  • Follow established deployment procedures at each site to complete device setup accurately and efficiently
  • Troubleshoot hardware, operating system, and access issues during the rollout and escalate complex cases to the designated support team when needed
  • Provide in-person technical assistance to end users throughout the deployment process to minimize downtime and confusion
What we offer
What we offer
  • medical
  • vision
  • dental
  • life and disability insurance
  • 401(k) plan
  • Fulltime
Read More
Arrow Right
New

Help Desk Analyst

Our team is hiring a Help Desk Analyst for a client based in the Philadelphia, P...
Location
Location
United States , Philadelphia
Salary
Salary:
Not provided
https://www.roberthalf.com Logo
Robert Half
Expiration Date
Until further notice
Flip Icon
Requirements
Requirements
  • Respond to incoming service desk requests and document issues clearly to ensure timely follow-up and resolution
  • Troubleshoot hardware, software, and operating system problems for users working in Microsoft Windows 10 environments
  • Assist with account access, password support, and user administration tasks within Active Directory
  • Diagnose basic technical issues, identify root causes, and escalate more complex problems when needed
  • Provide clear guidance to end users on system use, common fixes, and best practices to minimize recurring issues
  • Track, update, and close support tickets accurately while maintaining strong customer service throughout the support process
  • Experience providing help desk or service desk support in a detail-focused environment
  • Working knowledge of Active Directory for user account and access support
  • Hands-on experience supporting Microsoft Windows and Windows 10 systems
  • Ability to perform basic troubleshooting for common desktop, software, and access-related issues
Job Responsibility
Job Responsibility
  • Respond to incoming service desk requests and document issues clearly to ensure timely follow-up and resolution
  • Troubleshoot hardware, software, and operating system problems for users working in Microsoft Windows 10 environments
  • Assist with account access, password support, and user administration tasks within Active Directory
  • Diagnose basic technical issues, identify root causes, and escalate more complex problems when needed
  • Provide clear guidance to end users on system use, common fixes, and best practices to minimize recurring issues
  • Track, update, and close support tickets accurately while maintaining strong customer service throughout the support process
What we offer
What we offer
  • Medical, vision, dental, and life and disability insurance
  • 401(k) plan
  • Fulltime
Read More
Arrow Right