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The Validation department performs validation activities to ensure compliance with company procedures and industry standards in support of Operations and Quality Systems for primary and secondary Drug Product Manufacturing.
The ADL Validation department performs equipment, utility, facility, cleaning, sterilization and transport validation activities to ensure compliance with company procedures and industry standards in support of Operations and Quality Systems for Drug Product Manufacturing.
An exciting opportunity has opened in the ADL Validation Team for a Senior Validation Engineer. In this role, you will be responsible for delivering on the qualification and validation program at ADL, including planning and executing the sterilization validation / requalification, isolator qualification / requalification, and providing validation oversight of aseptic processing simulations.
The activities of the Validation Sr. Engineer are to:
* Provide technical validation support to meet site objectives, comprising of the full validation lifecycle process.
* Develop validation strategies and generate technical reports to support these strategies.
* Develop, review and approve validation plans, protocols, discrepancies, summary reports in the area of aseptic filling validation.
* Provide support for the aseptic process simulation program, including aseptic intervention review, protocol generation, execution and summary report generation.
* Provide support for the execution of cycle development, performance qualifications and requalification program in line with projects and site validation masterplans.
* Collate and report on relevant validation data and metrics.
* Assist in the development and improvements of the validation lifecycle process while ensuring continued compliance to all applicable regulations and Amgen standards. In addition, provide input and guidance into multisite and local procedural requirements.
* Provide validation support for Amgen’s quality management system, including change control, deviation and CAPA processes.
* Coordinate projects and prioritize workload in line with site priorities.
* Participate, when required, as a member of multidisciplinary site and multisite teams, e.g. cross functional investigation teams and change control GDEs
* Update and maintain validation Standard Operating Procedures (SOPs) in accordance with site and corporate requirements.
* Participate in regulatory inspections, regulatory filings and RTQs
* Attend and contribute to staff meetings and attend appropriate training sessions, as required.
* Comply with the responsibilities as outlined in the Site Safety Statement and champion safe working practices and initiatives within their functional area.
* Perform all tasks with due care and attention and in accordance with Good Manufacturing Practices and Amgen’s requirements, policies and procedures.
Basic Qualifications:
* Master’s degree with 5+ years of experience in validation, engineering or
* BS degree with 7+ years of experience in Validation, Engineering, Microbiology or Quality
Preferred Qualifications:
* In-depth understanding and application of validation principles, concepts, practices, and standards.
* In-depth knowledge with cGxP as well as regulatory regulations and compliance requirements for Biologics Drug Product manufacturing
* Extensive working knowledge of sterilisation/decontamination systems and industry practices.
* Experience with Aseptic Process Simulation/Media Fill
* Demonstrate active listening and continuous feedback within team, ability to facilitate problem solving, decision making, and issue resolution
* Demonstrate ability to successfully interact with other functions on projects that involve negotiation and collaboration with cross-functional peers and more senior management levels.
* Strong program and change management skills
* Excellent interpersonal, verbal, and written communication skills are essential in this collaborative work environment
* Comfortable in a fast-paced, dynamic, and highly fluid company environment with works under consultative direction toward pre-determined long-range goals and objectives.
* Able to adjust workload based upon changing priorities
* Previous people management experience highly desired.
* Able to express ideas and present information effectively to Amgen leadership, within team functions, and with external partners
* Ability to think critically with demonstrated troubleshooting and analytical skills.
Seniority level
* Seniority level
Not Applicable
Employment type
* Employment type
Full-time
Job function
* Industries
Biotechnology Research and Pharmaceutical Manufacturing
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