Senior Process Cleaning Validation Specialist

Inc. (Vti); London; On-site; CAD 70,000 - 110,000; Full time

Job summary

An established industry player is on the lookout for a Senior Cleaning Validation Engineer/Specialist to join their dynamic team in London, Ontario. This role offers a unique opportunity to work within the pharmaceutical and biotechnology sectors, collaborating with top-tier companies. You will be responsible for ensuring compliance with cGMP standards through rigorous cleaning validation processes and documentation. The position promises professional growth in a collaborative environment that values innovation and excellence. If you are passionate about making a significant impact in the life sciences field, this is the perfect opportunity for you.

Benefits

Competitive compensation

Excellent benefits

401K

Professional development

Training opportunities

Collaborative work environment

Qualifications

• 5+ years of Cleaning Validation experience in Biotech/Biologics/Pharma.
• Hands-on experience with IQ, OQ equipment qualification.
• Thorough knowledge of cGMP/FDA regulations.

Responsibilities

• Conduct post cleaning validation monitoring and cycle development.
• Maintain documentation for cleaning cycle development and validation.
• Participate in cleaning cycle development activities and protocol authoring.

Skills

Cleaning Validation

Interpersonal Skills

Analytical Skills

Risk Assessment

Education

Bachelor's degree in Engineering

Bachelor's degree in Chemistry

Bachelor's degree in Biology

Bachelor's degree in Chemical Engineering

Tools

cGMP regulations

FDA regulations

Job description

VTI Life Sciences (VTI) is seeking forward-thinking and ambitious engineers looking to accelerate their career in the pharmaceutical, biotechnology, and medical device industries. We offer an opportunity to help support our teams of industry subject matter experts and thought leaders while consulting with some of the biggest companies in the Life Sciences industries.

We are currently seeking a Senior Cleaning Validation Engineer/Specialist for our client in London, Ontario, Canada. This project will start in January 2025 and is expected to last for approximately 3+ months.

Responsibilities:

1. Post cleaning validation monitoring, cleaning cycle development, and cleaning validation in a cGMP facility.
2. Maintain all documentation pertaining to cleaning cycle development and validation.
3. Participate in cleaning cycle development activities including parameter selection, determining order of operations, authoring development and validation protocols, and reports.

Qualifications:

1. 5+ years of Cleaning Validation experience in Biotech/Biologics/Pharma industries.
2. Bachelor’s degree or higher in Engineering, Chemistry, Biology, Chemical Engineering, or related discipline.
3. Hands-on experience supporting/executing IQ, OQ (IOQ) equipment qualification related to various cleaning processes and activities in a solid dose facility.
4. Thorough knowledge of cGMP/FDA regulations and clean room environment.
5. Demonstrated ability in reviewing/writing technical documents, risk assessment reports, validation documents, IOQ protocols, and final reports.
6. Strong interpersonal skills, attention to detail, excellent review and analytical skills.
7. 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.