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- Aufgaben: Coordinate CQ activities for Fill Finish and Process Support Equipment, ensuring compliance and safety.
- Arbeitgeber: Join a leading company focused on innovative engineering solutions in the pharmaceutical industry.
- Mitarbeitervorteile: Enjoy competitive pay, hands-on experience, and opportunities for professional growth.
- Warum dieser Job: Be part of a dynamic team that values safety, quality, and collaboration in impactful projects.
- Gewünschte Qualifikationen: Ideal for candidates with knowledge in Process Commissioning and Qualification; relevant experience is a plus.
- Andere Informationen: This role offers a chance to work closely with various teams and vendors, enhancing your networking skills.
Das voraussichtliche Gehalt liegt zwischen 48000 - 84000 € pro Jahr.
Job Summary:
The scope of CQ activities relates to Fill Finish and Process Support Equipment, where schedule allows.
The CQ FF SME is responsible for coordinating CQ related activities including supporting Documentation Preparation, FAT, Installation, Hook Up, MC Oversight, active CQ Execution involving Safe / LOTO Team, Various Vendors, Calibration Group, Automation, CQV Team and Client USER – Ops and QA Team.
In line with PDP and Client C+Q requirements, the CQ SME will ensure adherence to the Baseline Schedule, Functional, Technical and GDP Compliance and adherence to Start Up safety procedures in line with best practices and Project expectations.
Main Responsibilities:
- General Management and Coordination in conjunction with Client and PDP Team:
- Meeting and delivering key project milestones
- Implementation of CORP-35 and supporting guidelines
- Adherence to EU Annex 15
- Actively Support CQ Documentation (FRAs, DQs, Gap Assessment, Client Commissioning, IQs and OQs)
- CQ Execution Readiness (Permits, Availability of Materials and Consumables, Tooling, Calibrations, Utilities, Ops support, Automation support and CQV support)
- Hands On CQ Execution (Vendor Oversight, Execution of Commissioning Protocols, IQ and OQ Test Plans)
- Participate in MC, P+ID Walk down and Punch item Categorisation
- Deviation/Incident Management & Change Control (Process)
- Punch List Management
- Vendor Management & Management of Third Party Support
- Reviewing CQ test plans and specifications prior to their approvals and post execution
- Management and Filing of CQV related documentation
- System and Area Handover
Main responsibilities and tasks relating to CQV documentation include but are not limited to:
- Coordinating development and approvals with the Client, Construction QA lead, and with other disciplines including Vendors, Automation, E+I, and USER etc.
- Developing positive working relationship with team members and USER groups
- Ensuring adherence to schedule, manhours and quality
- Review and approval of VTOD and CTOD
- Generation (Kneat digital platform) & execution of commissioning & qualification protocols
- Actively support Doc Prep team within the Kneat Systems
Execution Readiness:
- FAT support where requested
- Documented training on PSPs
- CQ Team development and resource allocation
- Monitoring and coordinating MC readiness
- CQV documentation readiness
- Monitoring and coordinating Automation readiness
- Monitor and coordinate SUT installation
- Appointment of Sub Contracts
- Calibration readiness including test equipment and resourcing
- HSE Plans, System PSSRs and LOTOTO device readiness
- Vendor notification of SAT dates per CQ Schedule
- Materials, consumables, spares, first fill available in stores
- Ensuring the fulfilment of the general pre-requisites, needed to start with CQV execution
CQV Execution:
- Ensure daily multidisciplinary CQV, Eng, CM and USER coordination meetings are established
- HSE management in conjunction with HSE Lead
- MC acceptance
- Coordinate CQV execution activities in conjunction with Vendors and Client Automation Group
- Execution of commissioning test protocols, IQ and OQ
- Vendor Management during SAT (Scheduling, Arrival On site, HSE Induction, SAT, IQ and OQ Oversight, Training, Handover)
- Ensuring compliance of the commissioning activities with qualification requirements where test results are subject to leveraging (FAT, VTOD, CTOD and SAT)
- Tracking of changes, punch items and deficiencies
- Reviewing first of type CQ test reports prior to their approvals
- Assisting system leads/engineers with system handover to production
- PQ and PPQ support where necessary
Project Controls:
- Planning & Scheduling
- Support with overall System based baseline CQV Schedule in conjunction with Engineering, CM and USER Group involving:
- System Definition & System Classification
- MC alignment with Construction
- Handover alignment with USER
- Progress Reporting & Progress measurement
- Scope changes
- Risks, Challenges and Mitigations
Key Performance Indicators:
- Strong knowledge and experience of Process Commissioning and Qualification Fill Finish and Process Support Equipment
- Management: Compliance with a schedule at a system and area level with the planned resource levels.
- Positive Feedback from Customer (i.e. Quality, HSE, operations)
- Safety: No lost time accidents and Focus on Start Up Safety
- Equipment Functionality: Robust and Repeatable Commissioning with no spurious alarms in line with URS, Technical and Functional specs. Well-executed Kneat Test protocols with minimum rework, deviations and re-execution
- Quality: Compliance with GDP, all deviations resolved to Client satisfaction and handover completed for all systems.
- Project Controls: Support with scheduling, punch item management, reporting and progress measurement
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CQ Fill Finish Engineer Arbeitgeber: Project Delivery Partners
Kontaktperson:
Project Delivery Partners HR Team
StudySmarter Bewerbungstipps 🤫
So bekommst du den Job: CQ Fill Finish Engineer
✨Tip Number 1
Familiarize yourself with the specific CQV documentation processes mentioned in the job description, such as FAT, IQ, and OQ protocols. Understanding these concepts will help you demonstrate your expertise during discussions.
✨Tip Number 2
Network with professionals in the Fill Finish and Process Support Equipment field. Engaging with industry peers can provide insights into best practices and may lead to referrals or recommendations for the position.
✨Tip Number 3
Stay updated on the latest regulations and guidelines related to EU Annex 15 and GDP compliance. Showing that you are knowledgeable about current standards will set you apart from other candidates.
✨Tip Number 4
Prepare to discuss your experience with vendor management and multidisciplinary coordination. Highlighting your ability to work effectively with various teams will be crucial in demonstrating your fit for this role.
Diese Fähigkeiten machen dich zur top Bewerber*in für die Stelle: CQ Fill Finish Engineer
Tipps für deine Bewerbung 🫡
Understand the Role: Make sure to thoroughly read the job description for the CQ Fill Finish Engineer position. Understand the key responsibilities and required skills, as this will help you tailor your application to highlight relevant experiences.
Highlight Relevant Experience: In your CV and cover letter, emphasize your experience with Process Commissioning and Qualification, especially in Fill Finish and Process Support Equipment. Use specific examples that demonstrate your ability to manage schedules, coordinate teams, and ensure compliance with safety and quality standards.
Showcase Your Teamwork Skills: Since the role involves coordination with various teams and vendors, make sure to illustrate your teamwork and communication skills. Provide examples of how you've successfully collaborated with different stakeholders in past projects.
Tailor Your Documents: Customize your CV and cover letter to reflect the language and requirements mentioned in the job description. Use keywords from the listing, such as 'CQV documentation', 'FAT', 'IQ', and 'OQ', to ensure your application resonates with the hiring team.
Wie du dich auf ein Vorstellungsgespräch bei Project Delivery Partners vorbereitest
✨Understand the CQV Process
Make sure you have a solid grasp of the Commissioning and Qualification (CQV) process, especially in relation to Fill Finish and Process Support Equipment. Be prepared to discuss your experience with FAT, IQ, and OQ protocols, as well as how you ensure compliance with GDP and safety procedures.
✨Showcase Your Coordination Skills
Highlight your ability to coordinate multidisciplinary teams and manage vendor relationships. Provide examples of how you've successfully led meetings and ensured adherence to schedules and project milestones in previous roles.
✨Demonstrate Problem-Solving Abilities
Be ready to discuss specific instances where you've managed deviations or incidents during CQV execution. Explain your approach to change control and how you ensure that all issues are resolved to client satisfaction.
✨Familiarize Yourself with Relevant Regulations
Brush up on EU Annex 15 and other relevant regulations that govern the CQV process. Showing that you understand these guidelines will demonstrate your commitment to compliance and quality assurance.
