Computer Scientist, Engineer - Lead of CSV & Automation (m/f/d)

Beschreibung

Senior Manager CSV and Automation (m/f/d)


Transformational advocate and champion responsible for strategy and implementation of CSV and automation within cGMP laboratories. Responsible for overseeing CSV activities and supporting automated laboratory workflows within existing, and newly built laboratories. Work closely with site management and laboratory scientists to successfully identify systems, develop, and convert manually performed assays, to automated platforms; with the goal of increasing capacity and precision, and reducing opportunities for human error. Lead the CSV/Automation department and work closely with individuals within the operations and quality departments to develop validation deliverables, ensuring “fit for purpose” and testing requirements that are defined, and are in compliance with the Master Validation Plan and applicable cGMP regulations.Your duties and responsibilities:

• Lead a group of CSV validation and Automation Engineers to ensure timely completion of projects with the PA Biologics facilities
• Engage with scientists across multiple departments to design and implement CSV & automation solutions, with the goal to increase efficiencies, capacity, turnaround times, and reduce opportunities for human error
• Lead collaborations and innovative efforts to convert manual assays to automated platforms
• Install, test, and validate new automation systems, and adapt existing automation systems to ensure they meet scientific needs, user functionality, and regulatory requirements
• Be a hands-on guide to support end users when faced with technical issues and provide comprehensive training and documentation to enable the end user to use the automation platform autonomously
• Prepare validation deliverables for computerized systems as required, including Validation Plans, Requirements Specification, Configuration Specifications, Risk Assessments, Test Scripts, Traceability Matrices, and Validation Summary Reports
• Coordinate and schedule system vendors with respect to the execution of Installation, Operation, and Performance Qualification (IQ/OQ/PQ) protocols and subsequent Re-Qualification (RQ) protocols if applicable for new and in-use equipment to ensure compliance with site procedures, Master Validation Plan (MVP), and regulatory requirements
• Provide ongoing Qualification/Validation and other appropriate System Lifecycle training/education of staff
• Participate in the development of corrective actions as needed for deficiencies that may be uncovered/observed during validation efforts to ensure compliance with applicable regulatory requirements/guidelines, procedures, and policies
• Participate in the development of CAPA’s and assess the effectiveness of the corrective action. Schedule validation project team meeting to ensure project milestone schedules are maintained and deliverables satisfy requirements.
• Assist as needed during client and regulatory audits and help to resolve or mitigate audit findings related to system qualification/validation
• Perform all other related duties as assigned

Your qualifications:

• Education: Bachelor’s degree (B.A./B.S.) or equivalent in a scientific, Engineering, IT discipline or related field
• A minimum of 8 to 10 years laboratory automation and computerized system validation related experience in a cGMP pharmaceutical, biotechnology and/or biomedical industry
• Working knowledge of lab equipment/instrumentation, test method, process, and facility validation in a regulated environment
• Must have: excellent oral and written communication skills. Strong documentation development and technical writing skills are critical to this position
• Must have: in-depth knowledge of accepted industry practices and the regulatory requirements that govern Computer System Validation in the pharmaceutical industry: 21 CFR Parts 210, 211, 820, 11, EU Annex-11, and applicable ICH and FDA guidance’s
• Leadership ability, project management, and facilitation skills required. Must be proficient with office software (word processing, spreadsheets, PowerPoint). Must have good interpersonal, organizational, and analytical skills

We offer you:

• A newly created challenging function with shaping opportunity together with a new team goal-orientated professional development compatibility of private life & work flexible working hours, flextime