Description
Are you a QA Validation Engineer? Are you interested in working for the leading names in the Bahamas in High-Tech Pharmaceutical Engineering?
Are you looking for hot weather?! Crystal clear waters?! White Sandy Beaches?!
Then stop what you are doing and read on!
Title: QA Validation Engineer
Rate: Negotiable
Location: Freeport, The Bahamas
Positions Available: 5 Engineers Needed
Type: Contract (12 Months)
A Fantastic new role has just opened up at one of the leading island based clients offering the successful candidate the opportunity to join a hard-working team working on exciting projects in the pharmaceutical sector.
The proposed start date is ASAP - We need YOU
Job Narrative
- As a member of the Quality organisation, the QA Validation Engineer is responsible for ensuring that all qualification and validation activities conducted by The client or approved third parties, comply with Company, Quality and regulatory requirements and expectations.
- To facilitate this, the QA Validation Engineer is responsible for providing hands on support as well as guidance and direction to all areas of the client organisation as well as its third party contractors. For clarity, the scope of the role includes Plant 2, Project Sunrise (P3) and any other department or function within the client that requires support related to Qualification and validation. This includes scheduled qualification and validation activities as well as those triggered by process/facility changes/improvements, deviations, customer and regulatory inspections etc
- Support of qualification and Validation activities takes many forms, including assisting with the development of validation documentation (plans, protocols, reports etc.) as well as facilitating and performing, where necessary, supporting activities such generation and review/approval of deviations, CAPAs, change requests, SOP/Work Instructions, Risk Assessments, system impact assessments, periodic key performance indicator reporting and all such supporting documentation necessary to perform the necessary qualification or validation activity to meet the relevant requirements.
- The QA Validation Engineer performs a supervisory role Plant 3, where equipment qualification activities are outsourced to a third party.
- The QA Validation Engineer role also has an element of in field activities, where the individual is expected to plan, execute (or coordinate execution) and report on qualification and validation activities. Examples include cleaning validation and Process Performance Qualification (PPQ)/Process Validation (PV) in Plant 3, system walk-downs, environmental monitoring program etc
Responsibilities include:
- Responsible for the execution and maintenance of the Site Validation Master Plan for The clients Technologies and ensures it is aligned with the current regulations and the Qualification and Validation cGMP's. Also responsible for providing hands on support, guidance and direction to the all the involved areas in the organisation with respect to validation activities. The Validation Engineer reports to the Validation Manager.
- Equipment, utilities, and facilities Qualification and Validation: reviews and lead the execution of all qualification and validation protocols and reports.
- Cleaning Validation
- Executes all activities to maintain the Validation Master Plan and related Standard Operating Procedures (SOP's)
- Executes the working plans for the Validation and re-validation of the Cleaning Methods
- Coordinates the sampling with production and QC labs teams in order to ensure that the samples required are taken expeditiously.
- During Process Validations ensure that the protocols and reports are completed by providing all the necessary guidance and direction to the protocols and reports and to the teams executing them
- Analytical Instrumentation Qualification and Validation
- Executes and maintain the Qualification Master Plan
- Provides Review and Advice with regards to the current Analytical Instrumentation Qualifications and Validation and has oversight during the execution of such validations.
- Review/execute/and has oversight of the System Validations related to Analytical Testing equipment
- Participates in all risk assessments/analysis that have impact in the Qualification and Validation processes
- Change Controls and Deviations
- Review and evaluates all changes that has resulted from validations and those can have an impact on validation or validated equipment
- Review and evaluates all deviations detected during the execution of qualifications and deviations and will participate and support all areas in the deviations that can have an impact on validated processes.
- Documentation
- Responsible for the review and approval of all documentation that regulates or impact the state of validation of any process, and qualification of any equipment, facility, and utility involved in the manufacturing of our products.
- Provides all the necessary data, facts, and information required in any process review or Management Meeting.
- Validation Key Performance Indicators (KPI's)
- Collects and periodically reports all data necessary to inform the state of validation for the site with special interest in the trends so data can drive the decision making for the site.
- The scope of this role will include all manufacturing, processing and analytical laboratories that are part of the Clients Technologies Manufacturing facilities in Freeport Grand Bahama.
Requirements:
- At least 10 years of hands on experience in Equipment Qualification and Process Validations in the Pharmaceutical Industry under cGMP regulations with API experience as well.
- B.S., M.S. or MBA in Science, Biology, Chemistry, or Engineering.
If you are interested please do not hesitate to email or call me!
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