Validation Engineer - North Carolina

Job Title: Process Validation

Location: North Carolina

Contract: 12M + extension

Schedule: 40 hours - standard business hours - flexibility to work shifts during execution phase.

Pay: $50 - $75 per hour

Please note you must be able to work in the US without restriction or sponsorship to be eligible for this role. If you are interested in finding out more about this role or others, please contact Manpreet Bhullar at mbhullar@i-pharmconsulting.com or call UK: +44 (0)20 7551 0802 / EU: +31 20 809 0665.

Job Title: Process Validation

Location: North Carolina

Contract: 12M + extension

Schedule: 40 hours - standard business hours - flexibility to work shifts during execution phase.

Package: Competitive + expenses

Please note you must be able to work in the US without restriction or sponsorship to be eligible for this role. If you are interested in finding out more about this role or others, please contact Manpreet Bhullar at mbhullar@i-pharmconsulting.com or call UK: +44 (0)20 7551 0802 / EU: +31 20 809 0665.

i-Pharm Consulting is teaming up with a global pharmaceutical powerhouse dedicated to daily innovation in the pursuit of making the world a healthier place. Currently, we are actively seeking a Process Validation Specialist to contribute to their groundbreaking projects on-site in North Carolina. In this dynamic role, you'll play an instrumental part in providing process validation support for their cutting-edge falling lines within state-of-the-art facilities.

Process Validation Engineer for Aseptic Fill/Finish Filling Line

We are on the lookout for a seasoned Process Validation Engineer to join our elite team, spearheading the validation efforts for a groundbreaking aseptic fill/finish filling line. As the key player in this role, you will be entrusted with ensuring the filling line not only meets but exceeds regulatory requirements and industry standards for aseptic manufacturing. Working in close collaboration with cross-functional teams, you'll proactively identify and address quality-related issues, ensuring unwavering compliance with regulatory requirements and industry standards.

Responsibilities:

• Develop and execute process validation protocols for the aseptic fill/finish filling line.
• Ensure stringent adherence to regulatory requirements and industry standards in aseptic manufacturing.
• Collaborate seamlessly with cross-functional teams to pinpoint and resolve quality-related issues.
• Craft and implement robust quality control procedures and protocols.
• Oversee the proper calibration and maintenance of filling line equipment.
• Review and give the green light to validation reports and protocols.
• Dive into investigative work, swiftly resolving quality issues linked to the filling line.
• Formulate and implement effective corrective and preventive actions (CAPAs) to stave off the recurrence of quality issues.

Qualifications:

• Bachelor's or master's degree in chemical engineering, Bioengineering, or a related field.
• A minimum of 5 years of hands-on experience in process validation or a closely related field.
• In-depth knowledge of regulatory requirements and industry standards in the realm of aseptic fill/finish manufacturing.
• Proven experience in aseptic filling & processing qualification and validation practices or sterile fill finish operations.
• Exceptional communication and interpersonal skills.
• Adept at problem-solving and decision-making in high-pressure situations.