Validation Engineer

Job Title: Validation Engineer

Job Location: Summit West, NJ (need local candidates only)

Job Duration: 6 months

Employment Type: W2 hourly

Highly preferred cell therapy equipment commissioning qualification.

Must Have: Develops validation/qualification deliverables such as Validation Plans, Requirements

Bachelor's degree required

100% Onsite position

Duration: 6 months(High Possibility of extension for right candidate)

Highly preferred cell therapy equipment commissioning qualification.

Must Have: Develops validation/qualification deliverables such as Validation Plans, Requirements

Specifications, Traceability Matrices, Summary Reports, Change Controls.

REQUIRED COMPETENCIES: Knowledge, Skills, and Abilities:

• Knowledge of cGMP, GXP, GAMP, SDLC regulations, including 21CFR part 11, computer
  
  

systems validation requirements and good documentation practices.

• Experience in the qualification of cell therapy equipment a plus
• Advanced knowledge of pharmaceutical, manufacturing and laboratory systems.
• Understanding of investigations, deviations and CAPA management in a regulated
  
  

pharmaceutical industry.

• Strong written and verbal communication skills.
• Excellent interpersonal skills with experience dealing with a diverse workforce.
• Strong multitasking ability in conjunction with proven organizational skills. Ability to organize
  
  

assigned tasks in a high paced environment and concurrently monitor tasks / assignments

with others that may impact timely completion. Ability to effectively manage multiple tasks

and activities simultaneously.

• Highly proficient computer skills in Microsoft Office Suite - Word, Excel, PowerPoint and
  
  

Outlook with extensive background in database systems. Innate ability to learn new software,

such as corporate intranet and enterprise business.

Education And Experience

• BS in Engineering or Science related discipline required
• Minimum of 5 years' experience performing/supporting activities in
  
  

a GMP environment.

• Minimum of 3 years' experience in equipment, facility or utility
  
  

qualification

Duties And Responsibilities

• Maintains qualified equipment systems in compliance with policies, guidelines and procedures:
• Develops qualification protocols, and associated reports while adhering to a change
  
  

management process.

• Supports the execution of equipment qualifications and validation protocols.
• Supervises vendors for qualification functions.
• Develops written procedures for calibration and preventive maintenance of equipment.
• Supports equipment qualification and validation activities.
• Develops validation/qualification deliverables such as Validation Plans, Requirements
  
  

Specifications, Traceability Matrices, Summary Reports, Change Controls.

• Manages projects of limited scope and complexity within their functional area:
• Supports equipment implementation projects including scheduling, procurement, site prep,
  
  

installation, qualification, and turn over to business area.

• Supports internal customer groups in the procurement, operation, calibration, and
  
  

preventive maintenance of equipment to meet business needs in accordance with required

schedules or dates.

• Completes all qualification and validation documentation with accuracy, completeness and
  
  

compliance to Client standards.

• Provides excellent customer service and support:
• Regularly reviews, prioritizes and promptly responds to customer equipment qualification
  
  

and support requests.

• Provides technical support and guidance on equipment qualification issues. Interfaces with
  
  

customers to ensure all expectations are being met.

• Provides technical support and guidance on equipment and computer systems qualification
  
  

and validations issues.

• Maintains a positive relationship with all team members and site customers while promoting
  
  

a positive team environment.

• Regulatory Responsibilities
• Ensure equipment, facilities and programs are maintained in compliance.
• May be called upon as SME in both internal and regulatory audits.
  
  

WORKING CONDITIONS (US Only)

Physical / Mental Demands:

• Occasional stooping, bending, stretching, pushing, pulling, reaching, and/or lifting to 25lbs
• Ability to sit, stand, walk and move within workspace for extended periods
• Ability to perform repetitive tasks including hand to finger manipulations, grasping, pushing and
  
  

pulling.

Environmental Conditions

• Primarily office environment, but will be required to enter laboratory or GMP process areas
  
  

donning proper gowning / lab coats or PPE such as safety glasses and shoes.

• Ability to work safely and effectively when working alone or working with others.
  
  

Thanks & Regards ,

Shivam Kamboj

Email- Shivam@applabsystems.com

Phone - +1 732-554-3865 (USA)

AppLab Systems, Inc: An E-Verified Company

URL: https://applabsystems.com/

4365 Route 1 South, Suite 105-Princeton, NJ -08540