What are the responsibilities and job description for the Process Validation Engineer position at Net2Source (N2S)?
Net2Source Inc. is an award-winning total workforce solutions company recognized by Staffing Industry Analysts for our accelerated growth of 300% in the last 3 years with over 5500 employees globally, with over 30 locations in the US and global operations in 32 countries. We believe in providing staffing solutions to address the current talent gap – Right Talent – Right Time – Right Place – Right Price and acting as a Career Coach to our consultants.
Company: One of Our Clients
Job Description:
Job Title: Validation Engineer
Location: Warsaw, IN 46580
Duration: 12 Months (Extendable)
Pay Rate: $30.00 – 35.00/hr on W2
Principal Duties and Responsibilities:
- Responsible for the development, execution, and management of installation, qualification, and validation documents and protocols for process equipment
- Support a wide variety of Equipment qualifications including CNC machines
- Guide, mentor, and cross-train team members to broaden validation capabilities, including equipment and process validation
- Create change requests in windchill to support equipment moves
- Execute to project plans and schedules for work activities.
- Communicate (written and verbal) with appropriate personnel from other departments.
- This is not an exhaustive list of duties or functions and might not necessarily comprise all of the essential functions for purposes of the Americans with Disabilities Act.
Expected Areas of Competence (i.e., knowledge, skills and abilities)
- Strong knowledge of cGMP regulations, including FDA, EMA and ISO requirements
- Experience writing and executing validation protocols and reports, including IQ/OQ/PQ documentation
- Proficiency with validation of manufacturing equipment, utilities, cleaning processes and computer systems
- Good problem-solving skills through the use of quality and statistical tools.
- Ability to effectively work within a cross-functional team to complete critical project tasks.
- Demonstrates good written and verbal communication skills.
- Strong technical writing and documentation skills
- Ability to independently develop and execute on project plans.
- Demonstrated ability to take initiative and provide recommendations on process, procedure and training.
Education/Experience Requirements
- B.S. in Engineering with a minimum of 3-year experience in validation in pharmaceutical/biotech manufacturing.
Awards and Accolades:
America's Most Honored Businesses (Top 10%)
Awarded by USPAAC for the Fastest Growing Business in the US
12th Fastest Growing Staffing Company in USA by Staffing industry Analysts in the US (2020, 2019, 2020)
Fastest 50 by NJ Biz (2020, 2019, 2020)
INC 5000 Fastest growing for 8 consecutive years in a row (only 1.26% companies make it to this list)
Top 100 by Dallas Business Journal (2020 and 2019)
Proven Supplier of the Year by Workforce Logiq (2020 and 2019)
2019 Spirit of Alliance Award by Agile1
2018 Best of the Best Platinum Award by Agile1
2018 TechServe Alliance Excellence Awards Winner
2017 Best of the Best Gold Award by Agile1(Act1 Group)
Salary : $30 - $35