Business Services & Consulting • all cities, PA 39
Site Location: Richmond, VA (Remote)
Program Overview: Constructing a new greenfield campus in Goochland County, Virginia focused on biologics and bioconjugate drug substance manufacturing.The site includes multiple manufacturing facilities, utilities, laboratories, administrative offices, and warehousing, with some drug product filling capability also included.The Richmond Automation Program supports this construction effort and is currently in the Basic Design phase.The program is organized under a central Automation Program Office, with independent Automation Project Teams assigned to each facility.
These teams are responsible for defining automation requirements, standards, and best practices, and for overseeing System Integrators who execute the detailed automation design, coding, and testing.
Purpose of the Role: Provide leadership and be responsible for the setup and direction of the CSV deliverables of the automation solution for the program.
Role Responsibilities: • Interface with Subject Matter Experts, Site and Area Management, Quality Assurance, and other client resources for key information for validation projects planning• Prepare CSV planning deliverables, such as Validation, Security, and Test Plans.• Collaborate with CSV leads on other projects• Support Validation efforts as per the Validation Plan and CSV document management plan expectations• Support the generation of individual project CSV documents, such as Project Validation Plan, Test Plan, and Electronic Testing Templates and objects in Kneat• Work collaboratively with equipment vendors and system integrator to ensure technical deliverables are compliant with CSV expectations, plans, and methods• Take part in Supplier Assessments, Risk Assessments, and Data Integrity Assessments• Recommend improvements for consistency or compliance in CSV deliverables• Ensure CSV documents comply with corporate Quality Standards and Practices, local templates, and electronic document management system properties and practices• Support good documentation of executed test cases in the electronic testing system, with both proactive education and post-execution troubleshooting, as guided by the document management plan and test plan• Create reports, views, and queries in Change management, Electronic Document Management, and Electronic Test systems to support project tracking• Develop spreadsheets/tools to analyze a large volume of validation artifacts• Support all CSV documents associated with the change control in alignment with the CSV document management plan expectations• Provide CSV mentoring and guidance for automation and other functional SMEs• Build a strong relationship with the CSQA personnel and be proactively aware of and respond to shifts in CSQ expectations and practices• Support onboarding, training, workload, attendance, and exits for validation personnel• Anticipate validation needs and trends in support of customer systems' validated state
Role Requirements: • BS in Engineering or equivalent preferred• 10+ years working experience in CSV within the Pharmaceutical industry• Previous Pharmaceutical Automation Large Project experience• Exceptional teamwork abilities• Electronic Document Management and Electronic Test Management experience preferred (Kneat)• Attention to detail in complex tasks, strong Microsoft Office software skills, experience in maintaining multiple simultaneous projects, experience interpreting and applying corporate standards and practices, excellent communication skills, strong web-based applications and reporting skills, e.g., change management and document management systems• Preferably, solid knowledge of GMPs, regulatory requirements, and computer system validation• Excellent written and verbal communication skills for both technical and non-technical audiences• Experience with DeltaV preferred
Deliverables: • CSV planning documents• Project-specific CSV documents• Review and approval of equipment vendor and system integrator documentation• Electronic Testing record implementation and maintenance• Change management planning, implementation and maintenance• Validation Artifact Analysis tool
Site Location: Richmond, VA (Remote)
Program Overview: Constructing a new greenfield campus in Goochland County, Virginia focused on biologics and bioconjugate drug substance manufacturing.The site includes multiple manufacturing facilities, utilities, laboratories, administrative offices, and warehousing, with some drug product filling capability also included.The Richmond Automation Program supports this construction effort and is currently in the Basic Design phase.The program is organized under a central Automation Program Office, with independent Automation Project Teams assigned to each facility.
These teams are responsible for defining automation requirements, standards, and best practices, and for overseeing System Integrators who execute the detailed automation design, coding, and testing.
Purpose of the Role: Provide leadership and be responsible for the setup and direction of the CSV deliverables of the automation solution for the program.
Role Responsibilities: • Interface with Subject Matter Experts, Site and Area Management, Quality Assurance, and other client resources for key information for validation projects planning• Prepare CSV planning deliverables, such as Validation, Security, and Test Plans.• Collaborate with CSV leads on other projects• Support Validation efforts as per the Validation Plan and CSV document management plan expectations• Support the generation of individual project CSV documents, such as Project Validation Plan, Test Plan, and Electronic Testing Templates and objects in Kneat• Work collaboratively with equipment vendors and system integrator to ensure technical deliverables are compliant with CSV expectations, plans, and methods• Take part in Supplier Assessments, Risk Assessments, and Data Integrity Assessments• Recommend improvements for consistency or compliance in CSV deliverables• Ensure CSV documents comply with corporate Quality Standards and Practices, local templates, and electronic document management system properties and practices• Support good documentation of executed test cases in the electronic testing system, with both proactive education and post-execution troubleshooting, as guided by the document management plan and test plan• Create reports, views, and queries in Change management, Electronic Document Management, and Electronic Test systems to support project tracking• Develop spreadsheets/tools to analyze a large volume of validation artifacts• Support all CSV documents associated with the change control in alignment with the CSV document management plan expectations• Provide CSV mentoring and guidance for automation and other functional SMEs• Build a strong relationship with the CSQA personnel and be proactively aware of and respond to shifts in CSQ expectations and practices• Support onboarding, training, workload, attendance, and exits for validation personnel• Anticipate validation needs and trends in support of customer systems' validated state
Role Requirements: • BS in Engineering or equivalent preferred• 10+ years working experience in CSV within the Pharmaceutical industry• Previous Pharmaceutical Automation Large Project experience• Exceptional teamwork abilities• Electronic Document Management and Electronic Test Management experience preferred (Kneat)• Attention to detail in complex tasks, strong Microsoft Office software skills, experience in maintaining multiple simultaneous projects, experience interpreting and applying corporate standards and practices, excellent communication skills, strong web-based applications and reporting skills, e.g., change management and document management systems• Preferably, solid knowledge of GMPs, regulatory requirements, and computer system validation• Excellent written and verbal communication skills for both technical and non-technical audiences• Experience with DeltaV preferred
Deliverables: • CSV planning documents• Project-specific CSV documents• Review and approval of equipment vendor and system integrator documentation• Electronic Testing record implementation and maintenance• Change management planning, implementation and maintenance• Validation Artifact Analysis tool
