Senior Computer Systems Validation Engineer - Astellas Pharma
Westborough, MA
About the Job
Do you want to be part of an inclusive team that works to develop innovative therapies for patients? Every day, we are driven to develop and deliver innovative and effective new medicines to patients and physicians. If you want to be part of this exciting work, you belong at Astellas!
Astellas Pharma Inc. is a pharmaceutical company conducting business in more than 70 countries around the world. We are committed to turning innovative science into medical solutions that bring value and hope to patients and their families. Keeping our focus on addressing unmet medical needs and conducting our business with ethics and integrity enables us to improve the health of people throughout the world. For more information on Astellas, please visit our website at www.astellas.com .
This position is based in Westborough, MA and is onsite.
Purpose and Scope:
The primary purpose of the Computer Systems Validation Senior Engineer role is to develop and execute validation strategies and deliverables for automated systems/equipment and site computerized systems in compliance with regulatory, and GMP guidelines in support of a cGMP Cell Therapy Manufacturing plant. The Computer Systems Validation (CSV) Senior Engineer will validate existing manufacturing equipment and processes, plan and implement continuous improvement initiatives, ensure design for manufacturability, and introduce and validate next-generation manufacturing operations. The CSV Senior Engineer is responsible for handling the CSV program including computer systems, equipment with computers, and data integrity generated by the computers programs.
Essential Job Responsibilities:
+ Provides scientifically sound, documented evidence that our systems and processes will perform as required to standards set forth by Quality Assurance, internal clients and global regulatory bodies. The evidence provided through the CQV program will ensure a quality, complaint manufacturing and testing environment. CSV Engineer will support CQV mission that all critical GMP equipment and systems are validated and maintained in compliance with user requirements, process parameters and global regulatory guidelines.
+ Generates, review, approves computerized system lifecycle documentation including risk assessment, functional specifications, traceability matrices, qualification protocols, validation plans, and summary reports.
+ Evaluates equipment and automation systems to design and implement protocols for validation in compliance with cGMP and regulatory requirements.
+ Performs Risk-Based Analysis and define 21 CFR Part 11 compliant approaches to validation.
+ Performs gap assessments of current computer systems to industry standards and develop plans to close gaps. Ensure CSV program meets all compliance requirements.
+ Works with operations, users, SMEs, IS, automation, and facilities during protocol execution and interact with other functions to facilitate protocol execution as necessary.
+ Performs periodic review of systems.
+ Develops testing strategies and rationale for systems.
+ Designs validation approaches, perform and coordinate all validation activities, analyze and assemble results, and draft validation reports.
+ Provides input in the global data integrity program for computer systems and lead various projects for implementation and maintenance of the program.
+ Coordinates validation activities across various departments and provide updates to management to ensure projects stay on track.
+ Develops processes and procedures for computer system validation and change control, including equipment with computers or PLC controllers.
+ Applies expertise in current computer validation requirements by industry standards and FDA to develop and implement compliant computer validation strategies.
+ Demonstrates excellent interpersonal skills, including the ability to resolve conflicts using poise, diplomacy and tact and the ability to interact with people of a wide variety of backgrounds, levels of responsibility and education levels.
+ Assures compliance with all in-house or external specifications to standards, such as ISO and GMP regulations.
+ Able to interface and build collaborative partnerships with multiple site functions including Manufacturing, Technical Operations, IT, and Quality to deliver site goals and objectives
+ Assess the impact to computer system modifications, including upgrades, and maintain change control through closure.
+ Provide technical or investigational support in troubleshooting and resolving validated equipment or system issues. Investigate and troubleshoot problems that occur and determine solutions and recommendations for changes and/or improvements.
+ Supplies management with relevant compliance insights; highlights and engages continuous improvement opportunities.
Organizational Context:
+ This position reports to the Senior Manager, Quality Systems
+ This position is an individual contributor role but serves as part of the larger GMP Quality Assurance department at AIRM.
+ This position requires onsite work.
Qualifications:
Required
+ Bachelor's Degree in Science, Engineering or Computer Science.
+ A minimum of 7 years' experience in related field of work within the biotech or pharmaceutical industry.
+ Good understanding of computer system validation and computer system management in cGMP operations
+ Understanding of Good Automatic Manufacturing Practices issue 5 (GAMP 5), 21 CFR Part 11, Annex 11, and other industry best practices is required. Must have specific knowledge of computer validation methodologies and principles.
+ Demonstrated knowledge and capabilities authoring validation documents for pharmaceutical manufacturing equipment, control systems and computerized systems
+ Proficient computer skills with experience using MS Office software
+ Excellent organizational, verbal and written communication skills with the ability to effectively communicate within cross-functional teams and to management
+ Excellent interpersonal skills and ability to work effectively and efficiently in a team-based environment with employees at all levels
+ Self-starter and detail oriented
+ Ability to discuss normally encountered technical issues, both verbally and written, in a manner that is understood by non-automation personnel
+ Ability and willingness to work within a high-performing team and collaborate effectively and respectfully with staff at all levels and of diverse backgrounds.
+ Oversee validation activities from contractors and/or vendors as necessary.
Preferred
+ Experience with an electronic document management system
+ Working knowledge of cell culture manufacturing platforms
+ Comfort presenting data, facilitating meetings with senior stakeholders, and maintaining minutes of key decisions and outcomes
+ Solid technical writing skills and ability to document work a meticulous, accurate and timely manner.
+ Solid written and oral communication skills and ability to work interdepartmentally with some basic supervision in an effective manner to carry out daily duties.
+ Experience in an environment subject to regulatory audits
+ Previous experience interacting with regulatory agencies, representing technical deliverables as a subject matter expert.
Working Conditions:
This position is an office/lab-centric position that requires onsite work.
Benefits:
+ Medical, Dental and Vision Insurance
+ Generous Paid Time Off options, including Vacation, Sick time, plus national holidays including Heritage Days, and Summer and Winter Breaks
+ 401(k) match and annual company contribution
+ Company paid life insurance
+ Annual Corporate Bonus and Quarterly Sales Incentive for eligible positions
+ Long Term Incentive Plan for eligible positions
+ Referral bonus program
#LI-SS
Category Institute for Regenerative Medicine
Astellas is committed to equality of opportunity in all aspects of employment.
EOE including Disability/Protected Veterans
Astellas Pharma Inc. is a pharmaceutical company conducting business in more than 70 countries around the world. We are committed to turning innovative science into medical solutions that bring value and hope to patients and their families. Keeping our focus on addressing unmet medical needs and conducting our business with ethics and integrity enables us to improve the health of people throughout the world. For more information on Astellas, please visit our website at www.astellas.com .
This position is based in Westborough, MA and is onsite.
Purpose and Scope:
The primary purpose of the Computer Systems Validation Senior Engineer role is to develop and execute validation strategies and deliverables for automated systems/equipment and site computerized systems in compliance with regulatory, and GMP guidelines in support of a cGMP Cell Therapy Manufacturing plant. The Computer Systems Validation (CSV) Senior Engineer will validate existing manufacturing equipment and processes, plan and implement continuous improvement initiatives, ensure design for manufacturability, and introduce and validate next-generation manufacturing operations. The CSV Senior Engineer is responsible for handling the CSV program including computer systems, equipment with computers, and data integrity generated by the computers programs.
Essential Job Responsibilities:
+ Provides scientifically sound, documented evidence that our systems and processes will perform as required to standards set forth by Quality Assurance, internal clients and global regulatory bodies. The evidence provided through the CQV program will ensure a quality, complaint manufacturing and testing environment. CSV Engineer will support CQV mission that all critical GMP equipment and systems are validated and maintained in compliance with user requirements, process parameters and global regulatory guidelines.
+ Generates, review, approves computerized system lifecycle documentation including risk assessment, functional specifications, traceability matrices, qualification protocols, validation plans, and summary reports.
+ Evaluates equipment and automation systems to design and implement protocols for validation in compliance with cGMP and regulatory requirements.
+ Performs Risk-Based Analysis and define 21 CFR Part 11 compliant approaches to validation.
+ Performs gap assessments of current computer systems to industry standards and develop plans to close gaps. Ensure CSV program meets all compliance requirements.
+ Works with operations, users, SMEs, IS, automation, and facilities during protocol execution and interact with other functions to facilitate protocol execution as necessary.
+ Performs periodic review of systems.
+ Develops testing strategies and rationale for systems.
+ Designs validation approaches, perform and coordinate all validation activities, analyze and assemble results, and draft validation reports.
+ Provides input in the global data integrity program for computer systems and lead various projects for implementation and maintenance of the program.
+ Coordinates validation activities across various departments and provide updates to management to ensure projects stay on track.
+ Develops processes and procedures for computer system validation and change control, including equipment with computers or PLC controllers.
+ Applies expertise in current computer validation requirements by industry standards and FDA to develop and implement compliant computer validation strategies.
+ Demonstrates excellent interpersonal skills, including the ability to resolve conflicts using poise, diplomacy and tact and the ability to interact with people of a wide variety of backgrounds, levels of responsibility and education levels.
+ Assures compliance with all in-house or external specifications to standards, such as ISO and GMP regulations.
+ Able to interface and build collaborative partnerships with multiple site functions including Manufacturing, Technical Operations, IT, and Quality to deliver site goals and objectives
+ Assess the impact to computer system modifications, including upgrades, and maintain change control through closure.
+ Provide technical or investigational support in troubleshooting and resolving validated equipment or system issues. Investigate and troubleshoot problems that occur and determine solutions and recommendations for changes and/or improvements.
+ Supplies management with relevant compliance insights; highlights and engages continuous improvement opportunities.
Organizational Context:
+ This position reports to the Senior Manager, Quality Systems
+ This position is an individual contributor role but serves as part of the larger GMP Quality Assurance department at AIRM.
+ This position requires onsite work.
Qualifications:
Required
+ Bachelor's Degree in Science, Engineering or Computer Science.
+ A minimum of 7 years' experience in related field of work within the biotech or pharmaceutical industry.
+ Good understanding of computer system validation and computer system management in cGMP operations
+ Understanding of Good Automatic Manufacturing Practices issue 5 (GAMP 5), 21 CFR Part 11, Annex 11, and other industry best practices is required. Must have specific knowledge of computer validation methodologies and principles.
+ Demonstrated knowledge and capabilities authoring validation documents for pharmaceutical manufacturing equipment, control systems and computerized systems
+ Proficient computer skills with experience using MS Office software
+ Excellent organizational, verbal and written communication skills with the ability to effectively communicate within cross-functional teams and to management
+ Excellent interpersonal skills and ability to work effectively and efficiently in a team-based environment with employees at all levels
+ Self-starter and detail oriented
+ Ability to discuss normally encountered technical issues, both verbally and written, in a manner that is understood by non-automation personnel
+ Ability and willingness to work within a high-performing team and collaborate effectively and respectfully with staff at all levels and of diverse backgrounds.
+ Oversee validation activities from contractors and/or vendors as necessary.
Preferred
+ Experience with an electronic document management system
+ Working knowledge of cell culture manufacturing platforms
+ Comfort presenting data, facilitating meetings with senior stakeholders, and maintaining minutes of key decisions and outcomes
+ Solid technical writing skills and ability to document work a meticulous, accurate and timely manner.
+ Solid written and oral communication skills and ability to work interdepartmentally with some basic supervision in an effective manner to carry out daily duties.
+ Experience in an environment subject to regulatory audits
+ Previous experience interacting with regulatory agencies, representing technical deliverables as a subject matter expert.
Working Conditions:
This position is an office/lab-centric position that requires onsite work.
Benefits:
+ Medical, Dental and Vision Insurance
+ Generous Paid Time Off options, including Vacation, Sick time, plus national holidays including Heritage Days, and Summer and Winter Breaks
+ 401(k) match and annual company contribution
+ Company paid life insurance
+ Annual Corporate Bonus and Quarterly Sales Incentive for eligible positions
+ Long Term Incentive Plan for eligible positions
+ Referral bonus program
#LI-SS
Category Institute for Regenerative Medicine
Astellas is committed to equality of opportunity in all aspects of employment.
EOE including Disability/Protected Veterans
Source : Astellas Pharma