Senior Process Cleaning Validation Specialist

Inc. (Vti); London; On-site; CAD 80,000 - 110,000; Full time

Job summary

VTI Life Sciences is seeking a Senior Process / Cleaning Validation Engineer to join their team in London, Ontario. This contract role will involve developing and executing qualification protocols across various projects in the pharmaceutical industry, requiring strong expertise in validation processes and regulatory standards. VTI offers a competitive compensation package and a collaborative work environment, making it an ideal opportunity for experienced professionals eager to progress in their careers.

Benefits

Professional development and training

Competitive compensation

Excellent benefits

401K plan

Collaborative work environment

Qualifications

• 5+ years of experience in Process and Cleaning Validation in Biotech / Pharma.
• Hands-on experience with Media Fill, Process, and Cleaning protocols.
• Thorough knowledge of cGMP / FDA regulations.

Responsibilities

• Develop media fill qualification protocols and produce summary reports.
• Develop cleaning validation protocols for multiple SVP filling lines.
• Support onsite execution of cleaning validation protocols.

Skills

Process Validation

Cleaning Validation

Media Fill Development

Technical Documentation

Risk Assessment

Interpersonal Skills

Analytical Skills

Education

Bachelor’s degree in Engineering, Chemistry, Biology, or related discipline

Job description

VTI Life Sciences (VTI) is seeking forward-thinking and ambitious engineers looking to accelerate their careers in the pharmaceutical, biotechnology, and medical device industries.

We offer an opportunity to support our team of industry Subject Matter Experts and thought leaders while consulting with some of the leading companies in the Life Sciences industries.

We are currently seeking a Senior Process / Cleaning Validation Engineer / Specialist for our Small Volume Parenteral (SVP) client in London Ontario Canada.

This is a CONTRACT position for a project that will start in May 2025 and is expected to last for approximately 3+ months.

Protocol development may be done remotely with onsite support of protocol execution required.

Responsibilities : Develop approximately four (4) media fill qualification protocols and produce protocol summary reports for aseptic filling lines.

Develop process validation protocols and produce protocol summary reports for approximately six (6) SVP filling lines and products.

Develop Blow / Fill / Seal machine PQ protocol and produce protocol summary report.

Develop mixing PQ protocols and produce protocol summary reports for two (2) Mixing Tanks.

Develop cleaning validation protocol and produce protocol summary report for Formulation Skid cleaning process.

Develop cleaning validation protocols and produce protocol summary reports for approximately four (4) SVP filling lines and products.

Onsite witnessing and support of cleaning validation protocol execution at the client facility in London Ontario Canada.

Qualifications : 5+ years of Process and Cleaning Validation experience in Biotech / Biologics / Pharma industries.

Hands-on experience developing / executing Media Fill, Process, and Cleaning process qualification protocols.

Bachelor’s degree or higher in Engineering, Chemistry, Biology, Chemical Engineering, or related discipline.

Thorough knowledge of cGMP / FDA regulations and clean room environment.

Demonstrated ability in reviewing / writing technical documents, risk assessment reports, validation documents, IOQ protocols and final reports.

Strong interpersonal skills, attention to detail, excellent review and analytical skills.

Must be able to organize and manage multiple tasks in a fast-paced environment.

VTI Life Sciences strives to maintain and inspire professional excellence by providing Commissioning, Qualification, Quality Engineering, Automation and Validation Services to the Pharmaceutical, Biotechnology, Biologics and Medical Device industries.

VTI offers professional development, training, competitive compensation, excellent benefits, 401K plus a stimulating and collaborative work environment.

We are committed to providing exciting career opportunities in a work environment that values trust, respect, openness, teamwork, creative talent, enthusiasm and diligence.

As one of the leading global Commissioning, Qualification and Validation Services organizations, VTI is always looking for innovative, talented and experienced validation professionals for our multinational and global offices.

We offer some of the best salary and benefit packages in the industry for our full-time / permanent employees.