Validation Technician

Lancesoft

Indianapolis, IN

Apply

JOB DETAILS

SALARY

$30

LOCATION

Indianapolis, IN

POSTED

18 days ago

Job Title: Validation Technician
Shift: Friday - Monday 7 am - 5pm (only during training period) & Thursday Sunday 7 am 5 PM
Location: Indianapolis (Onsite role)
Pay range: *** - *** based on skills and qualifications

Description:
The holder of this position is charged with supporting the critical aspects of operations, whether these relate to process, cleaning, equipment, utilities, computers or other elements.

Writing and executing media protocols, procedures and guiding documents for isolator fill line readiness.
Provide guidance to manufacturing, working with the operator, focusing on manufacturing process and ensuring the quality and validation are in compliance with the requirements.
Provide expertise on conducting assessments on documentation related to supply products manufacturing to adhere to Client QM, QD and global regulations.
Interact/collaborate with Tech/Ops functions to facilitate transfer of knowledge and deliverables for the isolator fill line readiness.
Monitor, and report on Key Performance Indicators (KPI) and performance measures of the validation team members to enable strategic objectives to be met for isolator fill line readiness.
Understand, develop validation PQ approaches and perform PQ executions for the isolator fill line readiness.
Contribute to validation policies, guidance documents (SOPs, VMPs, CPPs) detailing best practice approach with isolator fill line project focus.

Academic/Technical Qualifications:
Bachelor s Degree in a Science, Engineering or relevant discipline
5+ years relevant pharmaceutical and/or validation/qualification experience

Specialist/Technical Qualifications:
Must be (or quickly become) familiar with Regulatory requirements and guidance applicable in area(s) of deployment
Must be (or quickly become) familiar with the relevant areas of science applicable in area(s) of deployment
Must be (or quickly become) familiar with the general areas of technical knowledge / understanding

Experience:
Pharmaceutical: 5 years (Required)
Validation/Qualification: 5 years (Preferred)
Education:
Bachelor's (Required)

About the Company

Lancesoft

We are a $125 Million, NMSDC-certified Minority & Woman owned Workforce Solutions Company headquartered in the DC metro area with presence across US with global presence - Canada, Mexico, India, UK, Malaysia, Indonasia, Hongkong, Singapore, UAE. We are specialized in providing Workforce Solutions, SOW project delivery, Engineering Solutions, Creative Services. We currently support 100+ Fortune companies globally and across multiple industry segments. We are currently supporting several massive programs across industry segment nationally/globally (Intel, Ally, AMD, QUALCOMM, Morgan Stanley, Kraft/ Mondelez, MNP, Amdocs, Dell, SanDisk, Medtronic, Becton Dickinson, GE, Lockheed Martin, UTC, L-3 Communications, Caterpillar, BMW, Mercedes Benz, National Grid, Dominion, Energy Future Holdings, PSEG, 3M, Fidelity, Aetna, Humana, Johnson & Johnson, Pfizer, Merck etc).

All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender, identity, national origin, disability, or protected veteran status.

COMPANY SIZE

2,000 to 2,499 employees

INDUSTRY

Staffing/Employment Agencies

FOUNDED

2000

WEBSITE

http://www.lancesoft.com/

Resume Resources

Free Resume Templates Free Resume Builder