process validation engineer.carlsbad, californiaposted today job detailssummary$57 - $72 per hourcontractbachelor degreecategorylife, physical, and social science occupations reference 54666 job details job summary: The Validation Engineer is responsible for the design, schedule, execution, and evaluation of scientifically and statistically sound Qualification/Validation experiments which define and demonstrate that critical Cleaning, Controls, Equipment, Facilities, Processes and Utilities function in a consistent and repeatable manner, and are in compliance with regulatory requirements, product license restrictions, and policies affecting final product integrity.

location:

Carlsbad, California job type: Contract salary: $57 - 72 per hour work hours: 9 to 5 education: Bachelors responsibilities: Define and implement process validation framework?

Implement consistent process qualification, process validation and continuous process verification (CPV) strategiesDefine strategy for execution of process performance qualification (PPQ) and product life cycleGenerate, review, and approve process validation protocols and reportsLead development of studies around process hold time, homogeneity, mixing etcLead establishment of drug substance/API manufacturing process control strategies and assess process performance by monitoring and analyzing process/product dataLead process validation related investigationsWork closely with the client and personnel from Manufacturing, Process Development, Quality Control, Quality Assurance, Operations, and Project Management to ensure the scientific and CMC strategies are robust and maintained.

Data Management, Generation of Process Validation/CPV documents. Organizes, manages and interprets data, performs detailed data analysis. Execute complex validation impact assessments with robust rationale Process Validation SME in audits and customer meetings Manage escalation within MSAT, customer and Project Team as it relates to job function and deliverablesSelf starter with ability to manage work load with minimal supervisionAbility to drive sound decision makingAbility to drive project forward with collaborationComfortable in a fast-paced environment with the ability to adjust to changing priorities qualifications:

Minimum Qualifications:

Minimum of 7+ years' experience in cGMP environmentBachelor's or Master's degree Biochemistry, Chemistry, Chemical Engineering, Microbiology, or other Life Science related field5+ years' experience with process validation, Process Performance Qualification (PPQ) and / or Continued Process Verification (CPV)

Preferred Qualifications:

10+ years' experience / subject matter expert (SME) level of understanding with manufacturing, process validation, Process Performance Qualification (PPQ), and Continued Process Verification (CPV)5+ years of hands on experience working directly with cell culture upstream operations (flask expansion, cell stacks, bioreactors, clarification), or downstream purification (TFF (UF/DF), automated chromatography skids (AKTA, XMO), and/or sterile filtration)Ability to lead and influence teams/efforts and processes without direct authorityCritical thinking skills that translate into improved outcomes/outputs, and ability to effectively solve and derisk technical problems and form solutions/plans to mitigate issuesFamiliarity with cGMP document control systems and general proceduresExcellent attention to detail, with superior documentation and organization skillsExcellent computer, verbal, and written communication skills, including strong technical writing ability and a demonstrated ability to communicate scientific ideas to a broader cross-functional (technical/non-technical) audience skills: Chemistry, Microbiology, Good Laboratory Practices (GLP), Good Manufacturing Practices (GMP)

Equal Opportunity Employer:

Race, Color, Religion, Sex, Sexual Orientation, Gender Identity, National Origin, Age, Genetic Information, Disability, Protected Veteran Status, or any other legally protected group status.

At Randstad, we welcome people of all abilities and want to ensure that our hiring and interview process meets the needs of all applicants. If you require a reasonable accommodation to make your application or interview experience a great one, please contact HRsupport@randstadusa.com. Pay offered to a successful candidate will be based on several factors including the candidate's education, work experience, work location, specific job duties, certifications, etc. In addition, Randstad offers a comprehensive benefits package, including: medical, prescription, dental, vision, AD&D, and life insurance offerings, short-term disability, and a 401K plan (all benefits are based on eligibility). This posting is open for thirty (30) days. Qualified applicants in San Francisco with criminal histories will be considered for employment in accordance with the San Francisco Fair Chance Ordinance. Qualified applicants with arrest or conviction records will be considered for employment in accordance with the Los Angeles County Fair Chance Ordinance for Employers and the California Fair Chance Act. We will consider for employment all qualified Applicants, including those with criminal histories, in a manner consistent with the requirements of applicable state and local laws, including the City of Los Angeles' Fair Chance Initiative for Hiring Ordinance.