Manager of Equipment and Process Validation
Los Angeles, CA
Req ID 51723BR
Business Title
Manager of Equipment and Process Validation
Business
BioScience
Sub-Business
Manufacturing
Country
US
State/Province
California
Location of Position
Los Angeles, CA
Shift_
1st
Job Description
The Process and Equipment Validation Manager's focus will be on Process and Equipment Validation Responsibilities, using knowledge and previous experience with Equipment and Processes that are used in Pharmaceutical Manufacturing facilities. Various Filtration skids/Columns, CIP skids and processes, Centrifuges, Bulk Filling, Cleaning Validation and Optimization, SIP process, Several Tanks and related Transfer accessories and Distribution panels are among the basis equipment and Processes that are being used for LAMP Project. The candidate will be responsible for planning individual system / equipment, or Process Validation tasks. She/he participates in preparations and execution of various start up plans such as FAT, Commissioning and Validation. Candidate must have good understanding of Process development and Equipment specification and Manufacturing and associated piping, Installation and Validation effort. Finally, this candidate assures that The Qualification process is performed in compliance with Corporate, Division, and LA Plant SOP's and requirements. She/he will utilize the latest trends/Techniques of the industry, such as Risk Assessment process in the entire process of Validation/Qualification in order to manage the entire Qualification process efficiently and timely. The Equipment and Process Validation Manager will be working with a team of Consultants from several different companies and fields of expertise, as well as Baxter local and Division Engineering and Quality Assurance.
The Equipment and Process Validation Manager must be familiar with working in a regulated environment and familiar with cGMP issues and requirements. Adequate knowledgeable in both technical and regulatory aspects of the activities is required to be able to provide sound technical direction to assure optimal Validation effort, while in full compliance with Regulatory requirements. Candidate is a hands-on Manager and is able to write, review, and approve various Validation / Compliance related documents, as well as assisting in execution activities and preparation of Final Reports.
Duties include:
•Ability to multi-task and pay attention to several issues/projects simultaneously.
•Excellent verbal and written communication skills.
•Manage parts or entire projects. Be familiar with Project Management techniques and tools and be able to use them effectively.
•Knowledge of latest regulatory requirements for Process and Equipment Validation and Operation.
•Manage activities of a number of Validation Engineers on different but related projects. Manage subordinates activities and provide guidance and troubleshooting during all stages of Validation.
•Must actively participate in various pre-validation efforts on behalf of LAMP Quality Management in pre-start up activities.
•Provide direction and input in pre-validation activities, and provide direction and guidance to all individuals that are responsible for preparation of these documents.
•Review and approve cGMP related documents for compliance to BAXTER, as well as external regulatory requirements.
•Lead the development and execution of Process and Equipment validation project strategies crossing Engineering, Technical Services, Manufacturing, QA/QC and Regulatory disciplines; evaluate alternatives against agreed criteria. Responsible for defining and managing scope of work for project teams.
•Plans and schedules Process and Equipment validation projects. Is responsible for defining scope of work, resources and duration for individual projects to meet LAMP validation and budgetary goals.
Job Requirements
BS in Mechanical or Chemical Engineering with emphasis on process and equipment design.
Minimun of 8-10 years hands on experience.
•Must be well versed in validation disciplines (e.g. process and equipment validation methods and procedures) and have solid practical knowledge of Process / Equipment System Operation and Validation requirements. •Must possess working knowledge of regulatory requirements and new developments for Process Validation.
•Knowledge of GMPs, FDA guidelines, AND Risk Based approach to Validation.
•Must be self-motivated, have good interpersonal skills, capable of analyzing and solving complex problems through innovative thought and experience.
•Ability to design and influence in own area of expertise.
•Be involved in at least one industry interest group.
Doing Work that Matters
Baxter provides its employees with comprehensive compensation and benefits. To view additional opportunities at Baxter and to learn more about the company, please visit our Web site at company website. EOE M/F/D/V.
