Manager/Sr. Manager, Validation Job in San Diego 92121, California US
position description
BioPhase Solutions specializes in recruiting top talented professionals for San Diego's Scientific community. We are currently looking for a Manager/Sr. Manager, Validation to work for a leading San Diego biotechnology company.
Manager/Sr. Manager, Validation
Summary:
The purpose of this position is to lead all facility, equipment, process, and computer validation efforts at an existing pharmaceutical company with a new commercial product.
Essential Duties Responsibilities:
- Develop and manage timelines as well as execution of all activities required for the validation of a new manufacturing suite and subsequent process.
- Develop and manage validation plans that fully integrate the validation effort required for engineering, construction and commissioning of a new manufacturing area.
- Responsibility for the concurrent maintenance of validation compliance of two existing sites approved for commercial manufacturing.
- Develop external contractor requirements, budget and manage contract staff according to project requirements.
- Oversee and manage the development, execution and approval of validation protocols and final reports. In some cases, directly responsible for designated qualifications and validations.
- Responsible for aligning the validation approach with current regulatory requirements for successful FDA submissions and European authority approval.
- Manage the development and approval of validation SOPs and their integration into the overall validation strategy.
- Supervise validation staff and manage their career development.
Education and Experience:
- 12 years experience in the validation field of facilities, equipment and computers.
- Current in depth knowledge of FDA validation requirements in facilities, equipment and computers.
- BA in Engineering or Life Sciences
Knowledge, Skills, and Abilities:
- Ability to manage a staff will multiple levels of experience allowing reporting senior engineers to grow, have high responsibility and build their supervisory capabilities. At the same time provide leadership and nurture the junior staff using the senior engineers.
- Ability to establish validation goals, manage and track validation progress in required detail with data and project management tools.
- Ability to lead the development of the validation staff with working knowledge of most standard pharmaceutical validation disciplines.
- Ability to prepare for a new facility or major expansion of an existing facility for commercial launch of a product with all validation activities completed and ready for inspection.
- Ability to lead a successful validation department dealing with sterile pharmaceutical products.
- Ability to successfully pass a regulatory (FDA and/or EMEA) pre-approval inspection (PAI).
- Ability to directly author and execute validation protocols.
- Excellent communication and team work skills.
- Ability to maintain confidentiality.
Visit www.biophaseinc.com to view additional opportunities throughout Southern California!
May 21, 2011
• Tags: California Us, Manager, Sr. Manager, Validation Job in San Diego 92121 • Posted in: General