Validation Specialist

Synectics Inc

Thousand Oaks, CA, USA

Published: 6/14/2022

Technology

Full Time

Job Description

Job Summary

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.
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.

Qualifications

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.
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.
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.
Work is performed in office, laboratory, and cGMP manufacturing environments.
Entry into controlled areas and cleanrooms may be required; special gowning and protective equipment may be required.
May work around common laboratory or manufacturing materials, including cleaning agents, alcohols, and buffers.
Project timelines and manufacturing schedules may require schedule flexibility, including occasional off-shift or weekend support.

Benefits:

Healthcare Insurance: Synectics offers eligible employees and their dependents healthcare coverage through BlueCross BlueShield of Illinois. Eligibility begins on the 1st day of the calendar month following 60 days of continuous full time employment with Synectics. Premiums are subsidized by Synectics.

Dental Insurance: Synectics offers eligible employees and their dependents a dental plan through MetLife. Eligibility begins on the 1st day of the calendar month following 60 days of continuous full time employment with Synectics.

Vision Insurance: Synectics offers eligible employees vision insurance through VSP. Eligibility begins on the 1st day of the calendar month following 60 days of continuous full time employment with Synectics.

401(k) Plan: The Synectics Inc. Investment Savings Retirement Plan. Synectics offers all employees who are 21 years of age or older the opportunity to invest in the 401(k) Plan on the first of the month following at least 1 calendar year after employment begins.

Synectics is an equal opportunity employer.

\nCompany Description

Synectics is a leading staffing and workforce solutions company dedicated to connecting exceptional talent with top organizations. We specialize in IT, engineering, finance, healthcare, and professional services recruitment, offering both contract and permanent staffing solutions. With a people-first approach, we focus on understanding the unique needs of our clients and candidates to create long-term, successful matches. Our mission is to empower businesses with the right talent while helping professionals achieve rewarding career opportunities