The Validation Specialist will support qualification of Climet environmental monitoring instruments used in cGMP manufacturing suites. This role will author, execute, and close validation documentation; develop associated procedures; and coordinate activities with Quality, Manufacturing, Quality Control and other stakeholders. The individual will independently manage qualification deliverables while ensuring compliance with site procedures and applicable regulatory requirements.
job type: Permanent
salary: 70-$78.91 per hour
work hours: 9:00 AM – 5:00 PM
education: Bachelors Degree
responsibilities:
- Lead qualification activities for Climet environmental monitoring instruments and related components.
- Develop qualification plans, risk assessments, and project timelines.
- Author, review, and execute IQ, OQ and PQ protocols.
- Prepare qualification summary reports and final closeout documentation.
- Draft and revise SOPs, work instructions, forms, and other controlled documents.
- Coordinate instrument installation, vendor support, calibration, and maintenance activities as applicable.
- Document, investigate, and support closure of protocol discrepancies, and exceptions.
- Work cross-functionally with Quality Control, Quality Assurance, Manufacturing, and Information Technology.
- Ensure qualification records are complete, accurate, inspection-ready, and maintained in the site document management system.
- Track project milestones, communicate status, identify risks, and drive timely completion of deliverables.
- Bachelor’s degree in Engineering, Chemistry, Biology, Microbiology, Biotechnology, Pharmaceutical Sciences, or a related technical field preferred.
- Minimum of 3 years of relevant validation, equipment qualification, Quality Control, Engineering, Quality Assurance, or technical operations experience in a regulated manufacturing environment.
- Minimum of 2 years of direct experience writing and/or executing qualification protocols and preparing associated controlled documentation preferred.
- Equivalent combinations of education, training, and directly relevant experience may be considered.
- Experience qualifying equipment, instruments, or systems in a pharmaceutical, biotechnology, medical device, or similarly regulated environment.
- Hands-on experience authoring and executing IQ, OQ, and/or IOQ protocols.
- Strong technical writing skills, including protocols, reports, SOPs, and discrepancies.
- Working knowledge of cGMP, Good Documentation Practices, and applicable regulatory requirements, including 21 CFR.
- Familiarity with document management systems and electronic quality systems, experience with execution of IOQs through Kneat a plus.
- Ability to independently manage project deliverables, priorities, timelines, and follow-up actions.
- Ability to work effectively with cross-functional technical and quality teams.
- Strong attention to detail, organization, communication, and problem-solving skills.
- Proficiency with Microsoft Word, Excel, and Outlook.
- Experience with environmental monitoring systems, airborne particle counters, Climet instruments, cleanrooms, or QC Microbiology is preferred.
- Ability to perform desk-based documentation work and work in laboratory, manufacturing, and controlled-area environments.
- Ability to stand and walk for extended periods during protocol execution and field activities.
- Ability to occasionally bend, reach, stoop, push, pull, and move supplies or equipment.
- Ability to occasionally lift and carry up to approximately 25 pounds.
- Ability to wear required personal protective equipment and cleanroom gowning.
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.
