Senior Cleaning Validation Specialist - LS Solutions
Milford, MA 01757
About the Job
Title: Senior Cleaning Validation Specialist
Duration: 6 months + (Temp to Hire)
Location: Milford, MA 01757
Position Description:
Demonstrate a solid understanding, knowledge, skills set and experience in Cleaning Fundamentals (i.e., Regulatory Issues / Cleaning Validation Requirements; Cleaning Principles, Cleaning Strategies; Risk Assessments, Analytical/Sampling Methods, etc.).
As SME, provide cross functional leadership and quality / compliance expertise in cGMP US, EU and other regulatory best practices.
Apply best industry practices for various Cleaning Methods (i.e., Automated [Clean IN Place, CIP]; Semi-Automated [Clean Out Place, COP]; Manual Cleaning).
Design, plan and execute experiments (i.e., cleaning process design / development) to demonstrate robustness, optimize processes, efficiency of cleaning processes with the goal of product quality and safety.
Generate and modify cleaning procedures / work instructions for new products / new process and/or existing manufacturing equipment.
Lead and participate in the initial cleaning validation activities deliverables (i.e., scheduling, assessment; training; documentation; execution; issue resolution; reporting, etc.).
When required, investigate and conduct troubleshooting/root cause analysis of cleaning related incidents, deviations and cleaning out of specification results for non-validated or under development cleaning procedures.
Audit current cleaning processes and ensure compliance with cGMP, Site/Global quality policies and current industry standards.
Perform routine verification studies (continued process verification, CPV).
Maintain the validated status of cleaning processes.
Lead the cleaning validation program and activities requiring for the existing and /or new manufacturing processes.
Cleaning Process Design / Development
Provide technical support and expertise related to the cleaning process, critical quality attributes related to the output of the cleaning as well as critical cleaning agent parameters, process equipment assessment and analytical methods / recovery study).
Conduct Cleaning Verification deliverables and activities (as applicable) to demonstrate effectiveness of the cleaning process using a single cleaning and cleanliness testing exercise as part of cleaning process assessment.
Participate and support NPI / Technical Transfer when it comes to the introduction of new product, equipment and/or process to evaluate and establish cleaning validation requirements for existing manufacturing operations.
Cleaning Process Qualification
Responsible to provide documented evidence that the cleaning process design and cleaning procedures have been evaluated and demonstrate the cleaning process is capable of reproducible cleaning.
Generate validation protocols, risk assessments and supportive developmental studies for cleaning processes.
Conduct a risk - based approach throughout the cleaning process validation lifecycle from process design, throughout cleaning process qualification, and into continued cleaning process verification (i.e., grouping/worst case representatives; physical/chemical properties of soil / product residue; equipment design/equipment train; cleaning agents; analytical methods, etc.).
Establish equipment hold times (i.e., Dirty Hold Time [DHT] and Clean Hold Time [CHT]) throughout the set of cleaning process qualification activities.
Where applicable, generate Position Paper to provide equivalency in cleaning process/procedure for similar and/or identical process equipment cleaning.
Generate reports for cleaning process validation, and technical reports for specific projects.
Participate in project teams, working groups and task forces (local and or global).
Responsible for scientific and technical aspects of assigned projects and activities.
Interact with cross functional teams in Manufacturing Science; Operations/Production; Engineering; Facility; Quality (QC; QA) to support process development, process improvement and validation.
Required Skills:
Minimum education - Bachelors or Master degree in Life Sciences, Pharmacy, Chemistry; Biology or related Engineering discipline (Chemical Engineering).
Minimum of 5-7 years of professional hands-on and direct cleaning validation experience (CIP; COP; Manual Cleaning) in pharmaceutical / biotech industries.
Extensive knowledge of various cleaning techniques and technology.
Broad knowledge of regulatory compliance and its relation to cleaning of product contact equipment in the biopharmaceutical manufacturing environment.
Proficient knowledge of cleaning validation, continuous process improvement and troubleshooting processes.
Excellence in writing, reviewing and executing cleaning verification / validation protocols;
design of experiments (DOE); risk assessment and technical reports.
Strong project leadership skills.
Proven assessment, analytical and problem-solving skills.
Working experience in adopting ASTM E2500 standards.
Current member of ISPE in Cleaning Validation.
Expertise and experience with the contract development manufacturing and sterile / aseptic operations.
General knowledge of process flows and personnel flows in the biopharma manufacturing environment.
Employment Type: Contractor
Duration: 6 months + (Temp to Hire)
Location: Milford, MA 01757
Position Description:
Demonstrate a solid understanding, knowledge, skills set and experience in Cleaning Fundamentals (i.e., Regulatory Issues / Cleaning Validation Requirements; Cleaning Principles, Cleaning Strategies; Risk Assessments, Analytical/Sampling Methods, etc.).
As SME, provide cross functional leadership and quality / compliance expertise in cGMP US, EU and other regulatory best practices.
Apply best industry practices for various Cleaning Methods (i.e., Automated [Clean IN Place, CIP]; Semi-Automated [Clean Out Place, COP]; Manual Cleaning).
Design, plan and execute experiments (i.e., cleaning process design / development) to demonstrate robustness, optimize processes, efficiency of cleaning processes with the goal of product quality and safety.
Generate and modify cleaning procedures / work instructions for new products / new process and/or existing manufacturing equipment.
Lead and participate in the initial cleaning validation activities deliverables (i.e., scheduling, assessment; training; documentation; execution; issue resolution; reporting, etc.).
When required, investigate and conduct troubleshooting/root cause analysis of cleaning related incidents, deviations and cleaning out of specification results for non-validated or under development cleaning procedures.
Audit current cleaning processes and ensure compliance with cGMP, Site/Global quality policies and current industry standards.
Perform routine verification studies (continued process verification, CPV).
Maintain the validated status of cleaning processes.
Lead the cleaning validation program and activities requiring for the existing and /or new manufacturing processes.
Cleaning Process Design / Development
Provide technical support and expertise related to the cleaning process, critical quality attributes related to the output of the cleaning as well as critical cleaning agent parameters, process equipment assessment and analytical methods / recovery study).
Conduct Cleaning Verification deliverables and activities (as applicable) to demonstrate effectiveness of the cleaning process using a single cleaning and cleanliness testing exercise as part of cleaning process assessment.
Participate and support NPI / Technical Transfer when it comes to the introduction of new product, equipment and/or process to evaluate and establish cleaning validation requirements for existing manufacturing operations.
Cleaning Process Qualification
Responsible to provide documented evidence that the cleaning process design and cleaning procedures have been evaluated and demonstrate the cleaning process is capable of reproducible cleaning.
Generate validation protocols, risk assessments and supportive developmental studies for cleaning processes.
Conduct a risk - based approach throughout the cleaning process validation lifecycle from process design, throughout cleaning process qualification, and into continued cleaning process verification (i.e., grouping/worst case representatives; physical/chemical properties of soil / product residue; equipment design/equipment train; cleaning agents; analytical methods, etc.).
Establish equipment hold times (i.e., Dirty Hold Time [DHT] and Clean Hold Time [CHT]) throughout the set of cleaning process qualification activities.
Where applicable, generate Position Paper to provide equivalency in cleaning process/procedure for similar and/or identical process equipment cleaning.
Generate reports for cleaning process validation, and technical reports for specific projects.
Participate in project teams, working groups and task forces (local and or global).
Responsible for scientific and technical aspects of assigned projects and activities.
Interact with cross functional teams in Manufacturing Science; Operations/Production; Engineering; Facility; Quality (QC; QA) to support process development, process improvement and validation.
Required Skills:
Minimum education - Bachelors or Master degree in Life Sciences, Pharmacy, Chemistry; Biology or related Engineering discipline (Chemical Engineering).
Minimum of 5-7 years of professional hands-on and direct cleaning validation experience (CIP; COP; Manual Cleaning) in pharmaceutical / biotech industries.
Extensive knowledge of various cleaning techniques and technology.
Broad knowledge of regulatory compliance and its relation to cleaning of product contact equipment in the biopharmaceutical manufacturing environment.
Proficient knowledge of cleaning validation, continuous process improvement and troubleshooting processes.
Excellence in writing, reviewing and executing cleaning verification / validation protocols;
design of experiments (DOE); risk assessment and technical reports.
Strong project leadership skills.
Proven assessment, analytical and problem-solving skills.
Working experience in adopting ASTM E2500 standards.
Current member of ISPE in Cleaning Validation.
Expertise and experience with the contract development manufacturing and sterile / aseptic operations.
General knowledge of process flows and personnel flows in the biopharma manufacturing environment.
Employment Type: Contractor
Source : LS Solutions