Validation Engineers are recognized as a strong quality presence and technical resource. This position is responsible for developing, reviewing, and managing the execution of validation activities for the facility utilities, equipment and processes used in the manufacture and testing of cGMP products.
In the role of Validation Engineer, you will also be interacting cross-functionally with Manufacturing, Project Management, Process & Analytical Development, Quality Control, Quality Assurance, Packaging, Materials Management, Engineering, and Maintenance.
Responsibilities:
- Establish a Master Validation Plan, review and implement all necessary standard operating procedures for plant processes, equipment installation and operational qualification (IQ/OQ), performance qualification (PQ), requalification and revalidation of critical systems and utilities.
- Review, plan, schedule and implement new and existing validation projects including facility systems, manufacturing equipment and processes, analytical instrumentation, and cleaning processes.
- Recommend validation and qualification approaches, strategies, priorities and required resources during project planning and development phases.
- Develop and prepare protocols for process and cleaning validation, equipment commissioning and qualification (including but not limited to FAT/SAT/IOQ and PQ).
- Coordinate and oversee scheduled validation and qualification activities with facility and production engineers and operators, process and analytical development personnel, quality control staff, customers and external contractors and service providers.
- Review and analyze analytical and physical data generated from executed validation/qualification activities. Write validation/qualification final reports that present, summarize and offer conclusions on the validity of the processes based on objective evidence, obtain necessary approvals.
- Work with Development, Manufacturing and Quality personnel to generate risk management deliverables for new projects (Preliminary Hazard Analysis Assessments, Criticality Assessments, System Impact Assessments, Risk Management Reports, Failure Mode and Effects Analysis).
- Be a leader of the Management of Change system to determine the impact of proposed changes to the validation/qualification status of equipment, processes, software, and/or facilities.
- Report status and progress of validation/qualification activities or projects to the Leadership team.
- Specific Responsibilities to include:
- Facility Validation and Equipment Qualification:
- Develop/Establish an overall plan for qualifying new equipment or new/upgraded facility and establish proper controls for the introduction of equipment/facility and/or changes under proper quality standards (e.g. FDA, EU, ISO, ICH, ISPE, etc.)
- Identify and establish revalidation and requalification requirements
- Write and execute validation and qualification protocols including identification, investigation and resolution of non-conformances and deviations
- Author validation/qualification final reports
- Process Validation:
- Develop risk based process validation protocols in consultation with Process Development and Manufacturing
- Author process validation summary reports
- Cleaning Validation:
- Develop cleaning validation protocols for equipment and facilities
- Develop clean/dirty hold times
Basic Qualifications
· 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 [email protected]
Email Subject: Validation Engineer
Leon Leong De Cong
R1551708
Recruit Express Pte Ltd (Healthcare & Lifesciences Division)
EA License: 99C4599
