Job Description :
Under general supervision, reviews specifications and determines the critical aspects of facilities, utilities, computer systems and manufacturing equipment with regard to product and process quality, writes qualification protocols for operating systems and records related test results. prepares final reports that identify the results of protocol testing and the conditions of release.
Essential Job Functions:
• Carries out responsibilities in accordance with the organization's policies, procedures, and state, federal and local laws.
• Writes protocols that challenge the critical parameters related to installation, operation, and performance of the related facility, utilities, computer systems, or equipment.
• Assures that protocols are approved through proper channels; writes and revises validation protocols.
• Executes validation and qualification protocols per related SOPs and assures that acceptance criterion related to validation and qualification protocols are met.
• Analyzes new and existing equipment, recommends equipment modifications as needed for validation optimization.
• Assures that all test data is gathered and recorded in accordance with cGMP requirements.
• Analyzes data to ascertain if it meets related protocol acceptance criteria; writes deviation reports as required upon failures to meet protocol acceptance criteria.
• Writes final reports and assures that they are approved through proper channels.
• Performs necessary equipment and system IQ, OQ, and PQ's to assure compliance in all manufacturing and support areas.
• Develops and communicates project timelines and status.
• Complies with all GMP and safety requirements, SOP's and Company policies and procedures.
• Performs related duties as assigned.
• Work in self-directed manner and must be able to work on problems of a complex scope where analysis of data requires and in-depth evaluation of various factors
• Ability to exercise judgment within broadly defined practices and policies in selecting methods, techniques and evaluation criteria for obtaining results
• Demonstrated understanding and use of statistical methods in experiment design, data analysis, validation, and process monitoring
Job skills & knowledge:
• Current Good Manufacturing Practices (cGMP), Food and Drug Administration (FDA), and other regulatory requirements.
• Pharmaceutical principles, practices and applications.
• Principles of mathematical and statistical computations.
• Interpreting software and ladder logic diagrams and flowcharts.
• Interpreting electrical and mechanical blue prints and specifications including HVAC systems and. construction plans.
• Solving practical problems and considering a variety of concrete variables in situations where only limited standardization exists.
• Min 5 years experience working in a regulated environment
• Working knowledge of Standard Operating Procedures and Protocols/Reports
• Understanding of validation/qualification strategies
• Knowledge of applicable quality regulations and standards
• Quality or quality support experience in a regulated environment (GLP, cGMP, ISO)
• 3 years quality assurance or quality control experience in cGMP pharmaceutical or drug development organization
• Working knowledge of facility equipment commissioning and qualification
• Working knowledge of process and cleaning validation
• Working knowledge of Computer System Validation
• Quality assurance or quality control experience in a cGMP pharmaceutical setting
• Education: B.S. in an Engineering discipline, or Life Science degree
• Required: 3-5 years quality or quality support experience in a cGMP pharmaceutical setting
• Desired: 4-7 years facility, equipment, and/or cleaning validation experience in a cGMP manufacturing setting
• Sound working knowledge of processing equipment used to manufacture APIs
• Knowledge of clean room standards
Professional Skills, Qualifications and Experience:
• Strong ability to manage multiple priorities, self-starter attitude, good oral and writing skills and the ability to work independently and as a team in an efficient manner.
• Ability to utilize GDP during document creation and review.
• Working knowledge of current regulatory guidelines and standards.
• Ability to apply and incorporate pharmaceutical standards, rules and guidances. (e.g. FDA, EU, ISO, ICH, ISPE, etc.)
• Comfortable in a fast-paced environment with the ability to adjust to changing priorities.
• Flexible and accountable.
• Detailed oriented work standards.
• Office Hours 5 Days
Interested candidates please send a copy of your resume to [HIDDEN TEXT]
Email Subject: Validation Engineer – Leon
Leon Leong De Cong
Recruit Express Pte Ltd (Healthcare & Lifesciences Division)
EA License: 99C4599
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