- 193663 - Validation Engineer, Quality
- CA-Southern California - San Diego
- Up to $50.00 DOE
- 5 MOS
- Chipton-Ross is seeking a Validation Engineer for an opening in Carlsbad, CA.
The Validation Engineer will be responsible for validation deliverables for projects, as well as participation as an interactive member on Program and/or Project Teams. Write and execute validation documents for equipment, instruments, facilities, utilities, processes (cleaning and sterilization), and test methods in accordance with the Site Validation Master Plan, project specific Validation Plans, and departmental SOPs. The position is also responsible for the analysis of data, completion of validation protocols, and protocol and validation plan summary reports. Participation on various project teams will be required. The Validation Engineer provide validation guidance and training to operations.
Coordinate validation activities for the Carlsbad, CA site. Advise functional departments on the creation of user and system specifications requirements, as well as reviewing/approving these documents. Train personnel in all facets of validation activities. Author and/or revise validation and risk assessment SOP’s. Lead risk assessment efforts for evaluating existing equipment, processes and test methods. Perform, evaluate and analyze validation protocols and associated data for compliance with site requirements. Manage validation contractors as needed. Assist with execution and development of Validation Master Plan. Identify, schedule and perform validation studies to meet production and revalidation requirements. Evaluate and analyze validation data collected during projects, verify adequacy of the data and compliance with regulatory requirements. Summarize and evaluate protocol data, including resolution of discrepancies and exceptions as required for completion of validation summary reports. Perform periodic reviews or re-qualifications to maintain validation status of equipment, instruments, facilities, utilities and computer systems as defined by approved validation SOPs. Ensure qualification plans are in place for all required projects. Schedule validation runs to meet production and revalidation requirements. Review and approve protocols and studies. Support operations regarding validation during inspections or audits.. Prepare reports and validation summaries for work performed by those other than validation specialists. Performs other duties as assigned.
4-6 years validation experience in the pharmaceutical or medical device industry performing the tasks listed above. Influence and coordinate activities of personnel over which he/she has no direct authority. Work independently with minimal supervision. Hand’s on validation experience in process, equipment, test method and cleaning validations. Experience with change management assessments for validated equipment, systems, and processes. Demonstrated ability to work on multiple projects effectively. Excellent organizational skills and problem-solving abilities. High level of proficiency in Excel. Knowledge in standards and regulations such as ISO 9001, ISO 13485, GMP. Strong written and oral communication skills. Possess strong organizational skills with the ability to manage and prioritize multiple tasks and meet deadlines. Detail-oriented and accurate while maintaining a vision of the end result
Accredited B.S. Degree in Engineering or scientific discipline (STEM).
Employment will be contingent on clearing a drug screen and background check. Both must clear prior to start date.
420 Culver Boulevard
Playa Del Rey, CA 90293
Phone: (310) 414-7800 x286 or (800) 927-9318 x286
To ensure compliance with President Biden’s September 9, 2021 executive order, the client is implementing a new requirement for U.S.-based employees to either show proof of being fully vaccinated from COVID-19, or have an approved reasonable accommodation (based on a disability/medical condition or sincerely held religious belief) exempting them from the requirement, by December 8, 2021 (timing may vary in some states). Individuals who are unable to meet COVID-19 requirements due to a disability/medical condition or sincerely held religious belief may apply for a reasonable accommodation during the post-offer process. Individuals with approved accommodations will be subject to frequent COVID-19 testing.
Candidates responding to this posting must currently possess the eligibility to work in the United States. No third parties please.
Employment will be contingent on candidate clearing pre-employment drug screen and background check.
Chipton-Ross provides equal employment opportunities to all employees and applicants for employment without regard to race, color, creed, religion, national origin, sex (including pregnancy), age, disability, sexual orientation, gender identity and/or expression, protected veteran status, genetic information, or any other characteristic protected by Federal, State or local law. This policy governs all areas of employment at Chipton-Ross, including recruiting, hiring, training, assignment, promotions, compensation, benefits, discipline, and terminations.