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 looking for 2 Cleaning Validation Engineer Subject Matter Experts (SME) with 7+ years of experience to be involved in a 6+ month cleaning validation compliance project with our client in South Korea. The expected experience level typically includes a combination of technical knowledge, hands-on experience, and regulatory expertise.
o Length of Contract: 6 months (could be longer)
o Location – South Korea (full time onsite), two weeks back home remote
o All expenses paid
o Interviews begin October 2024
o Start mid-November 2024
o Three (3) months onsite, two (2) weeks back home working remotely, and return to South Korea for another three (3) months
o Strong writing and communication skills
o No VISA required for 90-day stay (3 months) for USA citizens and green card holders
Experience Level Years of Experience: 7+ years of direct experience in cleaning validation and cleaning process development within the pharmaceutical, biotechnology, or related regulated industries.
Industry Exposure: The SME should have worked in a GMP environment, particularly in manufacturing settings dealing with sterile, non-sterile, or multi-product facilities. Experience with small molecule, biologics, or cell and gene therapy is advantageous.
Leadership Experience: Experience in leading and managing cross-functional teams for cleaning validation projects, including collaborating with quality, production, engineering, and regulatory groups.
Technical Skills Cleaning Validation Protocols: Extensive experience in developing and executing cleaning validation protocols, including both worst-case cleaning scenarios and general cleaning SOPs.
Analytical Techniques: Proficiency with analytical techniques like HPLC, TOC, conductivity, and swab recovery methods, used for evaluating the effectiveness of cleaning procedures.
Cleaning Agents: In-depth knowledge of different cleaning agents (acidic, alkaline, solvents) and the selection criteria based on product residues, material compatibility, and cleaning cycle optimization.
Sampling and Recovery Studies: Expertise in designing and performing swabbing and rinse sampling, recovery studies, and calculating limits for acceptance criteria.
Regulatory Knowledge Regulatory Guidelines: Familiarity with FDA, EMA, ICH, PIC/S, and other regulatory guidelines relating to cleaning validation. Awareness of updates to Annex 1 (especially in terms of contamination control strategy) and the role of cleaning in preventing cross-contamination.
Health-Based Exposure Limits (HBEL): Understanding and application of HBEL principles, such as Acceptable Daily Exposure (ADE) and Permitted Daily Exposure (PDE), to establish Maximum Allowable Carryover (MACO) limits.
Audit Experience: Experience in preparing for and participating in regulatory inspections and audits, particularly concerning cleaning validation and control strategies. Ability to address observations and write comprehensive responses.
Validation Lifecycle Approach, Process Design, Qualification, and Verification: Experience with the full cleaning validation lifecycle approach, including process design, performance qualification (IQ/OQ/PQ), and continuous process verification.
Risk-Based Approach: Application of risk assessments, such as FMEA or HACCP, to identify critical cleaning parameters and ensure compliance through proper risk management practices.
Problem-Solving and GAP Analysis Root Cause Analysis: Skills in root cause analysis to address cleaning validation failures and identify corrective actions for contamination or inadequate cleaning issues.
GAP Analysis: Ability to perform cleaning validation GAP analysis for existing processes and develop plans to bring processes into compliance, particularly following regulatory changes or observations.
Documentation and Training Technical Writing: Competence in authoring validation protocols, reports, cleaning SOPs, cleaning matrices, risk assessments, and validation master plans. Clear documentation to satisfy both internal quality requirements and regulatory audits.
Training: Experience in training staff on cleaning procedures, swabbing methods, and best practices in contamination control.
Soft Skills Communication: Strong written and verbal communication skills to interact effectively with regulatory authorities, stakeholders, and cross-functional teams.
Project Management: Ability to manage timelines and resources effectively for cleaning validation projects, including coordination between departments for smooth project execution.
This experience and skill sets are crucial for a Cleaning Validation SME to successfully navigate the complexities of cleaning validation compliance, ensuring robust, compliant cleaning practices that meet industry standards and regulatory expectations.
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. www.validation.org
