Manager – Validation Engineer – Cell Therapy

Manager – Validation Engineer – Cell Therapy

Requirements

• Knowledge of Engineering and Quality Assurance generally attained through studies resulting in a B.S., in engineering, a related discipline, or its equivalent and applicable industry experience.
• Minimum 5 years of experience in FDA-regulated industry.
• Strong understanding of cGXP requirements and good documentation practices relating to systems, equipment and instrumentation within the pharmaceutical industry.
• Strong knowledge of ISPE C&Q guidance and 21 CFR Part 11 compliance.
• Technical writing capability and experience with writing, approving and training staff on SOPs and validation documents.
• Strong working knowledge of MS Windows client and server technologies including user groups, folder permissions and windows policies is preferred.
• Ability to learn new technologies while applying a strong technical skillset to configure computerized systems to meet Business and Regulatory requirements.
• Familiarity with SDLC, CSV deliverables, distributed control systems and automation (GAMP) validation concepts allows this individual to participate in cross-functional validation efforts.
• Ability to work with the end user to identify and document User and Functional Requirements.
• Knowledge of pharmaceutical laboratory and manufacturing systems.
• Experience authoring and executing standard C&Q deliverables.
• Ability to interact effectively with manufacturing, automation/IT, laboratory, QA, and Facilities groups.
• Strong ability to organize assigned tasks in a high paced environment and concurrently monitor tasks / assignments with others that may impact timely completion.
• Strong written and verbal communication skills along solid presentation skills.
• Proficient at writing well-formulated emails and reports.
• Ability to follow oral and written instructions, read and interpret engineering manuals/drawings relevant to the assigned task.
• Ability to effectively communicate with employees, contractors and vendors.
• Experience with technical writing and document development / generation.
• Strong computer skills in Microsoft Office Suite – Word, Excel, Visio and Outlook, and the ability to learn new software as required for equipment qualifications.
• Demonstrated understanding of engineering documentation such as P and IDs, Process Flow diagrams and Standard Operating Procedures.

Responsibilities

• Supports equipment qualification and validation activities by providing technical impact assessments and developing sound validation strategies.
• Develops validation/qualification deliverables such as Validation Plans, Requirements Specifications, Validation Protocols, Traceability Matrices, Summary Reports, Change Controls.
• Maintains all qualified and validated equipment and systems in compliance with policies, guidelines and procedures.
• Applies strong technical skillset to investigate and resolve complex challenges.
• Investigate and resolve Validation Deviations, CAPA investigations and other potential issues.
• Works with Automation/IT partners to ensure configuration and documentation of computerized systems to meet the requirements of CFR21 Part 11.
• Supervises vendors for qualification functions.
• Completes all qualification and validation documentation with accuracy, completeness and compliance to BMS standards.
• Responsible for the delivery of all lifecycle deliverables in the Qualification of facilities, utilities and equipment.
• Initiates, manages and leads projects of moderate scope and complexity within their functional area.
• Provide direction and leadership to other team members to ensure completion of objectives.
• Manages projects of varying scope and complexity.
• Maintains a positive relationship with all team members and site customers while promoting a positive learning, team environment.
• Author quality procedures and training documents.
• Deliver training on procedures and best practice to an audience that may include departmental personnel and business partners.
• Innovate, research and develop tools and solutions to provide more efficient and compliant solutions for department use and deployment.
• Supports laboratory and manufacturing equipment implementation projects including scheduling, procurement, site prep, installation, qualification, and turn over to business area.
• Support growing standardization efforts in the review and approval of Validation Deliverables.
• Regularly reviews, prioritizes and promptly responds to customer qualification, validation and support requests.
• Provides technical support and guidance on Validation, Quality Process and equipment qualification issues. Interfaces with customers to ensure all expectations are being met.
• Act as departmental delegate and SME in both internal and regulatory audits.

Preferred Qualifications

• Strong working knowledge of MS Windows client and server technologies including user groups, folder permissions and windows policies is preferred.