Validation Specialist II - Aequor Technologies LLC
Swiftwater, PA 18370
About the Job
Should be flexible and able to learn fast.
Previous experience in process validation and writing GMP documents is highly desirable (1-2 years). Good writing skills.
Proficient in word and excel. Should be able to work with transversal team. Also willing to go on shop floor and execute the studies following GMP and good documentation practice.
This role will need to work with a transversal team, so interpersonal skills are important. Also time management since this role will have to work under strict timelines to meet project schedule.
Should be willing to work flexible hours including evening/weekend (when needed, not routinely).
Onsite.
his position of Validation Specialist II, in the Manufacturing Technology (MTech) function of M&S-V, is to support manufacturing toward industrial excellence to guarantee the accuracy, conformity and competitiveness of the processes and techniques utilized for the production of the vaccines and biologics manufactured at the *** industrial sites. The mission of MTech is to deliver robust and efficient process & testing with associated know-how transfer to Manufacturing & Quality Control (QC). MTech's function also provides daily support, for manufacturing and QC, toward industrial performance excellence.
" Key contributor for strategy development and execution of development and process validation related to adjuvant manufacture. Provides input to industrialization strategies and rationale for critical process parameters. Subject Matter Expert (SME) for development and validation, health authority inspections, and investigations. The individual in this position will work with a cross-functional team from various functions in M&S-V to deliver following:
Accountabilities:
"Write protocols, reports, procedures, and memos as needed to support adjuvant manufacturing activities as they relate to engineering, investigational, definition, development and process validation runs
" Support execution of development and validation related studies.
" Document and interpret study results with recommendations
" Provide technical leadership as an subject matter expert in multiple areas of responsibility
" Develop and execution of training programs for appropriate audiences
" Comply with cGMP and other internal and external quality and regulatory guidance and health and safety guidelines.
" Provide leadership, including project team leadership, within area of expertise
" Assist with assessing existing processes and workflows.
" Translate processes to commercial operations.
" Ownership of equipment unit operations and technology capabilities. " Communicates findings and proposals to upper management.
" Improve Manufacturing Technology strategic programs by supporting non-conformance issues related to change controls, deviations, corrective and preventative actions (CAPAs).
" Participate in Gemba/ shop floor walk through to learn about production processes and / or interview stakeholders to collect data for continuous improvement of strategic programs and development of validation strategies/documents.
" Develop and update standard operating procedures and related technical documents to align to program strategies under a cGMP environment.
" Work closely with other members of the department to share knowledge and competencies encouraging individual growth and technical contributor.
The Job Responsibilities Include:
" Write protocols, reports, procedures and memos as needed to support Adjuvant manufacturing activities related to engineering, investigational, definition, development and process validation runs
" Support execution and documentation of engineering, development and/or validation studies and lead or supervise groups and/task force in the planning of engineering, investigational, definition, development and process validation runs.
" Input to design space / DOE studies through establishment of scale-up / scale-down parameters utilizing engineering fundamentals (mixing, mass / heat transfer, modeling, dimensionless parameters, etc.) and process control strategies.
" Provide technical assistance to manufacturing and quality operations for process troubleshooting, improvement, technical transfer and health authority inspections to achieving site metrics (+QDCI).
" Behaves according to company values and competencies.
" Forward thinking with an attitude of collaboration, optimization, efficiency, continuous improvement.
" Effectively communicates successes, constraints, conflicts, solutions and actions for resolution.
" Proactively resolves conflicts, removes roadblocks to execution within sphere of influence; escalates to functional management when appropriate.
" Fosters relationships with partners and customers in order to achieve technical objectives.
Education and experience
Basic Qualifications:
BS or MS in basic sciences, math, engineering or pharmacy with 2+ years' experience or PhD with experience in biological processes or analytics in a cGMP environment.
Preferred Skills:
" Proficient with structured methodologies such as Good Engineering Practices, Quality by Design, Design Space, & Process Control Strategies to be employed in the course of industrial process design, validation and control.
Excellent written and oral communication skills.
" Ability to work in cross functional teams, provide strong analytical skills for troubleshooting and root cause analysis, and communicate with internal and external team members.
" Experience in equipment start-up, qualification and validation is preferred.
" Prior experience preparing and executing process performance qualification documents (PPQ) preferred.
Previous experience in process validation and writing GMP documents is highly desirable (1-2 years). Good writing skills.
Proficient in word and excel. Should be able to work with transversal team. Also willing to go on shop floor and execute the studies following GMP and good documentation practice.
This role will need to work with a transversal team, so interpersonal skills are important. Also time management since this role will have to work under strict timelines to meet project schedule.
Should be willing to work flexible hours including evening/weekend (when needed, not routinely).
Onsite.
his position of Validation Specialist II, in the Manufacturing Technology (MTech) function of M&S-V, is to support manufacturing toward industrial excellence to guarantee the accuracy, conformity and competitiveness of the processes and techniques utilized for the production of the vaccines and biologics manufactured at the *** industrial sites. The mission of MTech is to deliver robust and efficient process & testing with associated know-how transfer to Manufacturing & Quality Control (QC). MTech's function also provides daily support, for manufacturing and QC, toward industrial performance excellence.
" Key contributor for strategy development and execution of development and process validation related to adjuvant manufacture. Provides input to industrialization strategies and rationale for critical process parameters. Subject Matter Expert (SME) for development and validation, health authority inspections, and investigations. The individual in this position will work with a cross-functional team from various functions in M&S-V to deliver following:
Accountabilities:
"Write protocols, reports, procedures, and memos as needed to support adjuvant manufacturing activities as they relate to engineering, investigational, definition, development and process validation runs
" Support execution of development and validation related studies.
" Document and interpret study results with recommendations
" Provide technical leadership as an subject matter expert in multiple areas of responsibility
" Develop and execution of training programs for appropriate audiences
" Comply with cGMP and other internal and external quality and regulatory guidance and health and safety guidelines.
" Provide leadership, including project team leadership, within area of expertise
" Assist with assessing existing processes and workflows.
" Translate processes to commercial operations.
" Ownership of equipment unit operations and technology capabilities. " Communicates findings and proposals to upper management.
" Improve Manufacturing Technology strategic programs by supporting non-conformance issues related to change controls, deviations, corrective and preventative actions (CAPAs).
" Participate in Gemba/ shop floor walk through to learn about production processes and / or interview stakeholders to collect data for continuous improvement of strategic programs and development of validation strategies/documents.
" Develop and update standard operating procedures and related technical documents to align to program strategies under a cGMP environment.
" Work closely with other members of the department to share knowledge and competencies encouraging individual growth and technical contributor.
The Job Responsibilities Include:
" Write protocols, reports, procedures and memos as needed to support Adjuvant manufacturing activities related to engineering, investigational, definition, development and process validation runs
" Support execution and documentation of engineering, development and/or validation studies and lead or supervise groups and/task force in the planning of engineering, investigational, definition, development and process validation runs.
" Input to design space / DOE studies through establishment of scale-up / scale-down parameters utilizing engineering fundamentals (mixing, mass / heat transfer, modeling, dimensionless parameters, etc.) and process control strategies.
" Provide technical assistance to manufacturing and quality operations for process troubleshooting, improvement, technical transfer and health authority inspections to achieving site metrics (+QDCI).
" Behaves according to company values and competencies.
" Forward thinking with an attitude of collaboration, optimization, efficiency, continuous improvement.
" Effectively communicates successes, constraints, conflicts, solutions and actions for resolution.
" Proactively resolves conflicts, removes roadblocks to execution within sphere of influence; escalates to functional management when appropriate.
" Fosters relationships with partners and customers in order to achieve technical objectives.
Education and experience
Basic Qualifications:
BS or MS in basic sciences, math, engineering or pharmacy with 2+ years' experience or PhD with experience in biological processes or analytics in a cGMP environment.
Preferred Skills:
" Proficient with structured methodologies such as Good Engineering Practices, Quality by Design, Design Space, & Process Control Strategies to be employed in the course of industrial process design, validation and control.
Excellent written and oral communication skills.
" Ability to work in cross functional teams, provide strong analytical skills for troubleshooting and root cause analysis, and communicate with internal and external team members.
" Experience in equipment start-up, qualification and validation is preferred.
" Prior experience preparing and executing process performance qualification documents (PPQ) preferred.
Source : Aequor Technologies LLC