Job description

Job Title - Validation Engineer

Location – Bloomington IN 47403

Duration- 6 Months

ONSITE - SHIFT - MON - FRI START TIME FLUCTUATE 7AM - 9AM.

Job Description

Requires in-depth knowledge and experience
Uses best practices and knowledge of internal or external business issues to improve products or services
Solves complex problems; takes a new perspective using existing solutions
Works independently and receives minimal guidance
Acts as a resource for colleagues with less experience
Competent at risk mitigation for function

TYPICAL MINIMUM EDUCATION AND/OR EXPERIENCE:

Bachelor’s degree or higher in STEM discipline
Master’s degree or higher preferred
2-5 years of experience in Validation or related discipline
1 year GMP experience required or other regulated industry
Must be able to read and understand English-written job instructions and safety requirements.

COMMON CHARACTERISTICS:

A validation engineers primary duty is to participate in validation projects relating to biopharmaceutical and pharmaceutical manufacturing equipment, critical computer systems, manufacturing processes and laboratory documentation.
Responsibilities include coordinating multiple projects, documenting activities via protocols and summary report templates help establish new templates and policies as needed, reviewing facility changes and provide input on re-validation, assessing risks involved in processing steps and related to equipment, developing and/or reviewing validation requirements and design deliverables, partnering with contract validation teams to support and monitor efforts, monitoring validation strategies, ensure polices are followed, conducting validation studies in accordance with batch records/protocols, and identifying exceptions associated with validation protocol execution.

FUNCTIONAL CHARACTERISTICS:

The validation department consists of four teams; Equipment/Facility, Process, Cleaning and Computer System Validation (CSV). The equipment/facility team initially qualifies and maintains the qualified state of all equipment,
facilities and utilities. The process team facilitates at-scale mixing and hold studies, qualifies new products, and maintains the media fill program.

The cleaning group qualified equipment used to remove product from manufacturing parts, qualified cleaning methods and performed routine TOC testing.

The CSV group qualifies new computer systems and changes to computer systems.

All teams support the manufacture of pharmaceutical products and often require direct contact with clients and internal customers across the site.

Successful candidates will have excellent communication skills, be self-motivated and action oriented.

This department requires individuals to independently problem solve, take ownership of their projects and drive to meet deadlines.

There is significant opportunity to learn, try new things and personally impact the business, our clients and ultimately patients taking the life-saving products we manufacture.

Thanks and Regards

Sai Sree

Job Types: Full-time, Contract

Pay: $65.00 per hour

Schedule:

• 8 hour shift

Education:

• Bachelor's (Required)

Experience:

• Validation Engineer: 5 years (Required)
• CGMP: 1 year (Required)

Work Location: In person

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