QA Validation Engineer

Alexza Pharmaceuticals is a specialty pharmaceutical company located in Mountain View, California. We are developing breakthrough therapies for the treatment of acute and intermittent medical conditions.

Alexza was founded by Dr. Alejandro Zaffaroni who is one of the most successful entrepreneurs in the biomedical industry with a long list of successful start-ups to his credit, including ALZA, Affymax and Affymetrix Corporations.

We have an exciting opportunity for a QA Validation Engineer. This person will work closely with our multi-disciplinary team of scientists and engineers who are dedicated to the development of novel drug delivery technologies with the potential to revolutionize the treatment of several common diseases.

Responsibilities:
• Review and Approve IQ, OQ, PQ, protocols for equipment, utility systems, automation systems, computerized systems, and manufacturing processes as required. 
• Review, and approve qualification final packages.
• Assist in the preparation of validation master plans for equipment, utility systems, automation systems, computerized systems, and manufacturing processes as required.
• Assures compliance to in-house and /or external specifications and standards, such as GMPs and ISO regulations.
• Assist in the implementation and maintenance of the company wide calibration program.
• Write and revise standard operating procedures related to validation program.
• May participate in internal and external audits
• Develop and maintain productive working relationships with Operations, Product and Process Development and Quality Control departments.

Skills Required: 
• Strong written and verbal communication, organizational and prioritization skills.
• Ability to handle multiple priorities in a project driven environment.
• Ability to work in a team environment and able to collaborate with others throughout the organization.
• The ability to maintain a flexible and a customer-oriented approach to problem-solving.
• Ability to maintain detailed and accurate records
 

Education and experience:

• BS in life sciences or related discipline.
• At least 7 years of validation in the medical device or pharmaceutical industry.
• Working knowledge of medical device and pharmaceutical cGMPs relating to validation requirements.
• Working knowledge of analytical chemistry, microbiology, and product development preferred.
• Proficient in the use of a wide variety of computer applications including the MS office, Excel, data base management systems, and project management software
• Must have a thorough knowledge of validation principles, manufacturing processes, quality systems, engineering design fundamentals, regulatory agency expectations and industry trends.


Grade level and title will be commensurate with education and experience of the selected candidate.

We offer competitive compensation and benefits including stock options, an exciting and collaborative work environment and excellent opportunity for career growth. 

Alexza Pharmaceuticals is an Equal Opportunity Employer. Direct Applicants only - NO AGENCIES, PLEASE.