Validation Engineer/Sr. Validation Engineer/Principal Validation Engineer
Location:
Philadelphia , Pennsylvania
Posted:
October 21, 2017
Reference:
R-014359
If you're inspired by the possibilities of science to change lives and you thrive when making brave decisions - join us.
MedImmune is the worldwide biologics research and development arm of AstraZeneca. Here, you'll have the opportunity to make a difference in people's lives every day. As one of the world's premier biotechnology companies, our mission is centered on delivering life-changing products that advance world health, and help fight and cure disease.  As a Validation Engineer/Sr. Validation Engineer/Principal Validation Engineer in Philadelphia PA, you'll play a pivotal role in channeling our scientific capabilities to make a positive impact on changing patients' lives.
We're constantly pushing the boundaries of science to deliver life-changing medicines to patients, with a passion for discovery and a pipeline to show for it. We're pioneering innovative research and exploring novel pathways across key therapeutic areas including oncology, respiratory, inflammation and autoimmunity, cardiovascular and metabolic disease, and infection and vaccines. And we're industry-leading in immunology, protein engineering and translational science. We offer a unique and strong collaborative network as part of the AstraZeneca family, as together we explore synergies between small and large molecules.
MedImmune has a dynamic environment that fosters collaboration and innovation. We attract top minds, and we nurture and build top talent.
Position Summary
Validation Engineer will be responsible for developing and implementing equipment (facilities, formulation/fill, packaging, and Quality Control), cleaning, sterilization, computer/automation, shipping, and method validation strategies by incorporating good engineering practices, risk-based validation principles and the regulatory requirements.  The Validation Engineer will collaborate with internal and external customers by providing oversight and technical guidance throughout the system lifecycle. The Validation Engineer will continually ensure systems and facilities comply with regulatory and Quality process requirements. 
Major Responsibilities
Participates in system design and commissioning project phases.
Provides oversight and technical guidance for Facilities, Formulation/Fill, and Packaging engineers during Installation and Operational Qualification.
Generates Validation Project Plan for complex projects and systems
Supports Risk Assessments documentation including but not limited to, System Impact Assessments, Components Criticality Assessments, Data Integrity Assessments and Automation Risk Assessments
Authors Validation Protocols and Reports for cleaning, sterilization, computer/automation, shipping and method processes.
Authors Validation Protocols and Reports for Controlled Temperature Units.
Supports Periodic Assessments on required frequency intervals
Performs Revalidations on required frequency interval
Resolves technical issues encountered during study execution
Schedules resources to approve and execute validation documents
Participating in SOP development as needed
Supports equipment start-up, shakedown, and cycle development
Interacts with regulatory agencies during inspections to speak to validation program and questions related to process validation life cycle
Implements/maintains governing cGMP procedures
Ensures training of employees and contractors to assure up-to-date knowledge of practices and procedures
Author and review change control documents 
Minimum Requirements
Validation Engineer
BS in Engineering, pharmacy or related science
Training or experience in in a cGMP biopharmaceutical production setting
Proficiency in at least one of the following disciplines: equipment qualification, process, cleaning, sterilization, methods, shipping, computerized/automation and materials validation
Solid organization, problem solving and decision-making
Solid team work and communication skills (oral and written)
Working knowledge of Microsoft Office Suite (Word, Excel, Project)
Senior Validation Engineer
Minimum 5 years' experience in GMP or regulated production environment working or equivalent post-graduate academic experience with 2 years' work experience
Expertise in two or more of the following discipline: equipment qualification, process, cleaning, sterilization, methods, shipping, computerized/automation and materials validation
Demonstrated ability to simultaneously support multiple projects
Ability to work independently or in collaboration with others;  Ability to effectively influence others in a matrix environment
Excellent verbal and written communication skills, able to present information to all organizational levels
Working knowledge and application of industry standards, safety, quality, and regulatory concepts
Working knowledge of Microsoft Office Suite (Word, Excel, Project)
Principal Validation Engineer
Minimum 10 years' experience in GMP or regulated production environment or equivalent post-graduate academic experience with 7 years' work experience
Expertise in five or more of the following disciplines: equipment qualification, process, cleaning, sterilization, methods, shipping, computerized/automation and materials validation
5+ years of strong leadership and project management skills
Advanced knowledge of cGMPs and FDA policies/procedures including experience interacting with regulatory authorities
Ability to work effectively as a leader and /or member of cross-functional team
Demonstrated ability to simultaneously manage/support multiple projects of high complexity
Application of Microsoft Office Suite (Word, Excel, Project) for project delivery
Experience in Six Sigma/ analytical trouble shooting skills
Experience working in a LEAN environment
Preferred Background
Validation Engineer
Previous Validation Experience including authoring documentation and execution
Strong verbal and written communication skills; influences others to act with full understanding
Proven ability to work effectively in a team environment; driving team and personal accountability
Ability to generate and interpret technical documents
Experienced in managing external technical relationships
Strong mechanical/technical aptitude
Experience in Six Sigma/ analytical trouble shooting skills
Experienced in working in a LEAN manufacturing environment
Validation Senior Engineer
Experience with any of the following Computerized/Automation, Method, and Shipping validations
Familiarity with ISPE Baseline Guide 5: Commissioning and Qualification and validation Risk Based approaches
Uses their insight to challenge and adapt current approaches/ways of doing things
Green Belt Six Sigma certification and experience working in a lean environment
Validation Principal Engineer
Expertize with Computerized/Automation, Method, and Shipping validations
Familiarity with ISPE Baseline Guide 5: Commissioning and Qualification and validation Risk Based approaches
Proven ability to develop team dynamics as well as personnel
Proven ability to work with all levels within the organization - locally and globally
Master's degree in an engineering or related scientific discipline
Black Belt Six Sigma certification and experience working in a lean environment
*LI-MEDI
~BSP
Next Steps - Apply today!
To be considered for this exciting opportunity, please complete the full application on our website at your earliest convenience - it is the only way that our Recruiter and Hiring Manager can know that you feel well qualified for this opportunity.  If you know someone who would be a great fit, please share this posting with them.
AstraZeneca is an equal opportunity employer. AstraZeneca will consider all qualified applicants for employment without discrimination on grounds of disability, sex or sexual orientation, pregnancy or maternity leave status, race or national or ethnic origin, age, religion or belief, gender identity or re-assignment, marital or civil partnership status, protected veteran status (if applicable) or any other characteristic protected by law.

A little about us:
MedImmune is the global biologics research and development arm of AstraZeneca

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