Validation Engineer

Experienced CQV/Commissioning/Validation Engineer - 12 Month Contract (Possible Extension)

Location: Swiftwater, PA (Remote Until Covid)

Schedule: 1st Shift, 9:00 am - 5 pm EST

Overview

Join our dynamic team as an experienced CQV/Commissioning/Validation Engineer. In this role, you will play a crucial part in ensuring the successful operation and validation of equipment within the pharmaceutical/biopharmaceutical or related manufacturing environment. If you have a solid background in plant utilities, clean utilities, HVAC, filling lines, CTUs, component prep equipment, and formulation, along with strong communication and project management skills, we want to hear from you.

Requirements

 

• BSc/BEng in Engineering, preferably Mechanical, Manufacturing/Industrial, or equivalent combination of education and experience.
• 3-5 years of experience in the CQV field.
• Previous experience in the pharmaceutical/biopharmaceutical or related industry/manufacturing environment.
• Excellent written and verbal communication skills.
• Proficient in commissioning, qualification, and validation processes.
• Experience troubleshooting equipment in a manufacturing setting.
• Continuous improvement mindset with knowledge of Lean & Six Sigma tools.
• Preferred, but not required, experience in the pharma or medical device industry.
  
   

Responsibilities

 

• Collaborate with cross-functional teams to execute CQV activities for various equipment and systems, focusing on plant utilities, clean utilities, HVAC, filling lines, CTUs, component prep equipment, and formulation.
• Ensure compliance with industry regulations and internal quality standards.
• Identify and troubleshoot issues to ensure smooth operations.
• Utilize project management skills to prioritize and coordinate tasks effectively.
• Drive continuous improvement initiatives to enhance processes and efficiency.
• Maintain clear and concise documentation of validation activities.
  
   

Hybrid Work Environment

This position offers a flexible work environment, with the option to primarily work remotely. However, as needed, the successful candidate will be expected to be on-site for equipment executions, issue troubleshooting, and other essential tasks. Therefore, proximity to Swiftwater, PA is preferred.

Joining our team provides an opportunity to be a part of a thriving organization within the pharmaceutical/biopharmaceutical industry, with the potential for contract extensions. If you are a self-motivated professional seeking a challenging role in CQV, apply now to join our team!