- Responsible for review of qualification and validation documentation, such as protocols, reports and SOPs for new facilities/cleanroom validations/commissioning activities.
- Responsible for review of qualification protocols (IQ/OQ/PQ) and validation assessments for equipment used in manufacturing suites.
- Review of equipment user requirements.
- Responsible for ensuring validations are executed as per the procedures and protocols.
- Review and approve final validation/qualification packages.
- Execute protocols when required.
- Work with multiple groups (external and internal) in accomplishing the tasks assigned.
- Review vendor documents before and after qualification activities.
- Responsible for ensuring the validation documentation complies with both internal requirements and external regulations.
- Completing risk assessments to ensure equipment, systems, processes and facilities remain in a validated state.
- Conducting impact assessments, root cause analysis and resolution for validation deviations
- Monitoring any changes or maintenance to equipment and make the decisions on whether a full revalidation is required.
- Support in Change plans.
- Support with the environmental monitoring program as required.
- Mapping out the manufacturing processes and finding ways to improve processes.
- Project planning, scheduling and reporting, and working with the Project Manager to ensure delivery timelines are met.
- Bachelor's Degree in science or engineering with experience in facilities and equipment validation.
- Experience of GMP manufacturing, facilities, equipment qualifications and process validations, including cleanrooms.
- Knowledge of cGMP manufacturing regulations for the MHRA, FDA and other countries as required.
- Experience in commissioning of new buildings/facilities, including cleanrooms.
- Detailed knowledge of facility and equipment qualification processes.
- Demonstrated track record of high levels of personal and independent productivity.
- Possess excellent verbal and written communication skills.
- Good technical writing skills for drafting and revising validation SOPs that comply with both internal requirements and external regulations.
- Demonstrated collaborative and teamwork skills, with a high level of decision making and problem solving.
- Thorough grasp of H&S, quality, and SOP requirements.
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Quality Assurance Validation Engineer - Bristol, United Kingdom - LiCa Scientific Ltd
Description
Quality Assurance Validation Engineer
Permanent
Bristol
We are pleased to be partnering with our long standing client in Bristol at an exciting time in their business where they will be commissioning a new Good Manufacturing Practice (GMP) facility. This will be in a new building and be a blank canvas for the new Quality Assurance and Validation Engineer to work on
You will be working with colleagues both internal and external on commissioning and qualification of this new GMP facility. This will include equipment IQ/OQ/PQ activities, as well as validation and qualification of the ISO 7 and ISO 8 cleanrooms. You will be responsible broadly for all systems and make sure they are running to required specifications.
The duties of the role will include:
We are seeking a candidate with excellent problem solving, organisational skills, strong attention to detail and who will be self motivated with a can-do approach.
Your background:
On this occasion, LiCa Scientific is acting as an employment agency.
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