Cqv lead Job at Darwin Recruitment GmbH

Lead Engineer CQV

Discover your exciting role. Exyte is a global leader in design, engineering and...

Location

Germany , Nürnberg

Salary:

Not provided

Exyte Central Europe GmbH

Expiration Date

Until further notice

Requirements

Degree in Biotechnology, Pharmaceutical, Building Services Engineering or Process Engineering or related field
Several years of experience in CQV within life sciences industry, including leadership responsibilities
Strong knowledge of GMP, ISO, 21 CFR, Annex 15, data integrity
Proven ability to lead teams and manage complex projects
Fluent German and good English skills required
High level of quality awareness, efficiency, and accuracy

Job Responsibility

Lead and mentor CQV engineers, ensuring efficient resource allocation and professional development
Define CQV strategies and ensure alignment with project objectives, timelines, and compliance requirements
Supervise commissioning, qualification, and validation activities for HVAC, cleanroom, and clean media systems according to GMP regulations
Approve CQV documentation (specifications, risk analyses, protocols, reports) and ensure regulatory compliance
Act as primary interface between CQV team, clients, technical engineering, automation, QA, and suppliers
Oversee FAT/SAT activities and review supplier documentation
Implement best practices and drive process optimization across projects

What we offer

Your Start at Exyte: Join a two-day onboarding event with new colleagues
Attractive Location: Spacious workspaces with height-adjustable desks
Buddy System: Several weeks of onboarding with your teammates
Work-Life Balance: Option to switch to mobile working at any time
Catering: Free specialty coffees and water dispensers on every floor
Stay Fit: Exyte subsidizes your fitness membership via Qualitrain at over 5,000 locations across Germany

Fulltime

Senior Engineer CQV

Shape innovative projects in the pharmaceutical industry and take on responsibil...

Location

Switzerland , Basel

Salary:

Not provided

Exyte Central Europe GmbH

Expiration Date

Until further notice

Requirements

Degree in engineering, natural sciences, or a pharmaceutical-related field
Willingness to travel within Switzerland
Strong knowledge of GMP regulations and common industry standards
High level of quality awareness and attention to detail in documentation
Several years of professional experience in the pharmaceutical industry
Very good German and good English skills (corporate language)

Job Responsibility

Preparation of qualification and validation plans
Preparation and review of specifications, risk analyses, design documents, and project processes
Planning and execution of DQ, IQ, OQ, and PQ for production equipment
Preparation of qualification reports
Review of supplier documentation and coordination of supplier activities
GMP-compliant documentation of executed work
Handling of changes and deviations (Change Control & Deviations)
Preparation of Standard Operating Procedures (SOPs)
Maintenance and archiving of documentation
Ensuring training standards of project team members

Fulltime

Associate Director Engineering – Global Capital Project Delivery

Amgen is seeking an Associate Director with experience in complex engineering, c...

Location

Portugal , Lisbon

Salary:

Not provided

Amgen

Expiration Date

Until further notice

Requirements

Bachelor's or Master's degree in Engineering, Project Management, Procurement or related discipline
10+ Years experience leading complex capital projects and / or project controls in a global organization
Strong understanding of supplier management, procurement interfaces, and project execution
Leadership and transformation experience. Ability to build new capabilities, operating models, or scalable business processes
Strong stakeholder management and influencing skills across global teams
A data-driven mindset with experience improving visibility, reporting, and decision-making
Experience in pharmaceutical, biotechnology, life sciences, advanced manufacturing, or other regulated industries preferred

Job Responsibility

Build and lead the Strategic Equipment Delivery workstream within Project Controls, including governance, stakeholder alignment, and scalable ways of working
Lead workstream to improve the predictability and visibility of end-to-end capital equipment delivery across Amgen's global project portfolio
Partner with engineering, procurement, sourcing, CQV, and project teams to drive integrated equipment planning and execution
Strengthen supplier engagement through improved milestone tracking, risk management, escalation processes, and delivery performance
Support early identification and mitigation of long-lead and business-critical equipment risks
Drive standardization, reporting, and data-driven decision-making to improve delivery performance and cost optimization
Collaborate with digital and analytics teams to enhance dashboards, reporting, and equipment delivery insights
Support supplier documentation readiness across the equipment lifecycle in partnership with cross-functional teams

What we offer

Vast opportunities to learn, develop, and move up and across our global organization
Diverse and inclusive community of belonging, where colleagues are empowered to bring ideas to the table, take risks, and act
Generous AMGEN Total Rewards Plan comprising healthcare, finance, wealth, and career benefits
Flexible work arrangements

Fulltime

Senior Manufacturing Associate I

Beam Therapeutics is a biotechnology company committed to establishing the leadi...

Location

United States , Durham

Salary:

80000.00 - 115000.00 USD / Year

Beam Therapeutics

Expiration Date

Until further notice

Requirements

BS/MS in Life Sciences or Engineering a plus with minimum of 4-6 years of relevant experience
Experience in SAP, Veeva, and Cell Therapy operations strongly preferred
Outstanding written and verbal written communication skills
Results oriented with the ability to demonstrate resiliency, ownership, and drive
Team oriented with excellent collaboration skills
Must be able to work onsite daily and willing to have a flexible schedule during peak times, which may include supporting critical operations outside of normal work hours, as needed

Job Responsibility

Support multiple areas of GMP production, and lead most operations as needed
Establish and maintain strong relationships at the site and cross-functionally
Manages and maintains training qualifications for assigned operations, operates as lead trainer on most operations
Identifies and revises manufacturing documents (Equipment SOPs) as required
Drafts change controls as required and manages small projects for area
Performs limited CQV required tasks when needed for any new plant expansions or upgrades
Operate in up to an ISO 5/Grade B environment

Fulltime

Director - Site Validation

At Amgen, our mission is to serve patients. At our Dun Laoghaire (ADL) site, we ...

Location

Ireland , Dun Laoghaire

Salary:

Not provided

Amgen

Expiration Date

Until further notice

Requirements

Doctorate degree and 4 years of directly relevant experience
Master’s degree and 8 years of directly related experience
Bachelor’s degree in Engineering, Life Sciences, or associated discipline and 10 years of directly related experience
Within experience must have 4 years of managerial experience directly managing people and/or leadership experience leading teams, projects, and programs or directing the allocation of resources
Extensive experience in validation within a sterile/aseptic manufacturing environment (fill-finish highly preferred)
Strong expertise in: Aseptic process simulation (media fills)
Cleaning validation
Equipment qualification and lifecycle management
Commissioning and qualification (CQV) for capital projects
Proven experience supporting large-scale capital project delivery and facility start-ups

Job Responsibility

Strategic leadership for all site validation activities, ensuring alignment with Amgen global standards, regulatory requirements, and site objectives
Leading and developing a high-performing Validation organisation, setting clear expectations and fostering a culture of quality, compliance, accountability, and continuous improvement
Development of the organisation includes robust succession planning as well as a focus on how the function will support 24/7 operations e.g. via a new validation shift team
Owning all validation lifecycle activities including: Aseptic Process Simulations (media fills) strategy and execution
Airflow Visualisation Studies (AVS) and HVAC requalification programs
Sterilisation validation (VHP, autoclaves, SIP/CIP, lyophilisation)
Cleaning validation programs
Equipment validation
Facilities and Utilities
Effective continued process verification and lifecycle validation, including periodic review, requalification and data-driven performance monitoring programs

What we offer

Vast opportunities to learn and move up and across our global organisation
Diverse and inclusive community of belonging, where teammates are empowered to bring ideas to the table and act
Generous Total Rewards Plan — including health, finance, and wealth benefits
Flexible work models, including remote and hybrid work arrangements, where possible

Fulltime

Engineering Manager – F&E Readiness

Amgen Dun Laoghaire (ADL) is developing a next-generation, technologically advan...

Location

Ireland , Dun Laoghaire

Salary:

Not provided

Amgen

Expiration Date

Until further notice

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

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

competitive salary
comprehensive Total Rewards Plan including health, financial and career development benefits

CQV Coordinator Pharmaceuticals

We are looking for a CQV manager to provide documented evidence that all equipme...

Location

Belgium , Beerse

Salary:

Not provided

Amaris Consulting

Expiration Date

Until further notice

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

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

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

Fulltime

Thermal Validation & CQV Engineer

We are seeking an experienced Thermal Validation & CQV Engineer to lead and exec...

Location

Canada , Toronto

Salary:

Not provided

Amaris Consulting

Expiration Date

Until further notice

Requirements

Bachelor’s degree in Engineering, Pharmaceutical Sciences, Microbiology, or a related discipline
3–6 years of CQV/CSV/thermal validation experience in a GMP pharmaceutical or biotech environment (Consultant/Intermediate level)
Strong hands-on experience with thermal cycle development, heat penetration studies, and BI logistics
Strong hands-on experience with temperature mapping and smoke studies
Strong hands-on experience with IOQ/PQ execution and requalification activities
Solid understanding of FAT/SAT, risk-based validation, FCCA, RTM, and CSV principles
Proficiency in Kaye AVS systems and familiar with Kneat and/or Veeva Vault
Strong knowledge of GMP/GLP/GDP/EHS and ALCOA+ data integrity standards
Excellent skills in technical writing, data/statistical analysis, and problem-solving

Job Responsibility

Lead and execute CQV activities for facilities, utilities, and process equipment across routine operations and capital projects
Author and review risk-based C&Q documentation: FCCA, RTM, DQ, CTP, IOQ/PQ, EM PQ, smoke studies, and thermal validation protocols
Plan and perform FAT/SAT, critical test plans, and CSV activities where applicable
Perform thermal validation using Kaye AVS v1.4+ (or equivalent)
Validate sterilization and decontamination systems
Support annual validation programs
Investigate and document deviations and non-conformances
Own documentation and scheduling
Collaborate closely with Operations, MSAT, Automation, Engineering & Maintenance, and Quality teams
Promote continuous improvement and provide mentorship and guidance to junior validation staff

What we offer

An international community bringing together more than 110 different nationalities
An environment where trust is central: 70% of our leaders started their careers at the entry level
A strong training system with our internal Academy and more than 250 modules available
A dynamic work environment that frequently comes together for internal events (afterworks, team buildings, etc.)

Select Country

Cqv lead

Job Description

Requirements

Nice to have

Looking for more opportunities?

Cqv lead

Lead Engineer CQV

Senior Engineer CQV

Associate Director Engineering – Global Capital Project Delivery

Senior Manufacturing Associate I

Director - Site Validation

Engineering Manager – F&E Readiness

CQV Coordinator Pharmaceuticals

Thermal Validation & CQV Engineer

Our AI answers in your language