Senior Engineer/ Principal Engineer/Engineer III, Validation
The Principal/Senior Engineer/Engineer III, Corporate Validation provides technical supports for commissioning, qualification and validation (CQV) activities related to manufacturing process, production equipment, and/or critical utility systems for domestic and oversea locations as well as relevant external CMOs. These will encompass new facility/equipment, new functionality, process/equipment changes and modifications, cleaning, sterilization, gamma irradiation and periodic requalification/revalidation.
The incumbent will support/prepare the development of project plans, protocols, test scripts and reports throughout all stages of validation from initiation to continuous monitoring. The incumbent will work with functional area representatives and equipment supplier to finalize validation requirements for process, equipment and systems, ensuring that company policies and procedures, applicable regulations and guidelines are followed during project execution and validation life cycle. Furthermore, the incumbent executes validation activities, manages contractor and coordinates with other departments.
Duties and Responsibilities:
- Lead/support the qualification of manufacturing equipment, facility and critical utility systems.
- Lead/support validation of cleaning (CIP and manual), shipping, and sterilization (steam and dry heat) processes.
- Supervise and provides guidance to junior full time employees and contracted personnel performing validation activities. Define scope of work and bid out project, as needed.
- Manage the development and execution of FATs, SATs, DQ, IQ, OQ, PQ and other relevant validation life cycle documents, such as commissioning plans and test scripts, commission summary reports.
- Manage/support the development of master plans, validation plans, SOPs, system impact assessments, criticality assessments, risk assessment and validation protocols for new facility/equipment, new functionality/process, process/equipment changes and modifications, and periodic requalification/revalidation.
- Support development of overall validation strategy, programs and policies, Master Plans, and SOPs pertaining to governance of validation lifecycle.
- Collaborate with multiple departments including Product development, Manufacturing, Engineering, Facilities, and QA/QC to complete validation related assignments.
- Support corrective actions including investigating and resolving deviations as relevant to validation.
- Bachelor's Degree or higher in Engineering, Life Sciences or related disciplines.
- Hands on experience in developing validation plans/protocols, field execution, and preparing validation final reports.
- Expertise or strong knowledge in one or more of the following areas are required: Facility/Utilities and Equipment Qualification, Cleaning Validation, Sterilization Validation, Media Fill or Shipping validation. Expertise in Process Validation is a plus.
- Highly knowledgeable in both domestic and international GMP regulations (FDA and EMA) and industry guidance documents (e.g. ICH, PDA, ISO, PIC/S, and ISPE), and incorporate continuous improvements and best industry practice into validation activities and policies.
- Hands on experience with regulatory inspection is a highly desirable.
- Knowledge of Automation Software Validation is a plus.
- Strong understanding of risk-and science-based validation approaches is desired.
- Experience with system and process risk assessments; including FMEA, and HAZOP.
- Knowledge of drug/device combination products is highly desirable.
- Project planning experience is a plus.
- Demonstrated knowledge of pharmaceutical manufacturing of sterile products, or aseptic processing, and/or drug/device combination product manufacturing
- Must demonstrate the ability to think critically and analytically, including ability to demonstrate trouble-shooting and problem solving skills
- Strong interpersonal, follow up, and verbal and written communication skills
- Ability to function efficiently and independently in a fast-paced, changing environment
- Read and interpret drawings such as blueprints, AutoCAD, P&ID.
- Expert Microsoft Word and Intermediate Microsoft Excel skills are required
- Strong team player aligned with Intarcia Corporate Values
- 10+ years (7+ years for Senior Engineer, 5+ years for Engineer III) of relevant validation experience
- Aseptic process experience is a must
- Experience with Fill/Finish process and isolator technology is high desirable
- 5 to 7 years of hands on qualification experience in a cGMP environment (IQ, OQ, PQ) is required