Title: Digital Validation BA
Duration: 10 month contract + extensions
Location: Onsite – North Wales, PA
Pay Rate: $53-59/hr
Compensation:
$53/hr to $59/hr
Exact compensation may vary based on several factors, including skills, experience, and education.
Benefit packages for this role will start on the 31st day of employment and include medical, dental, and vision insurance, as well as HSA, FSA, and DCFSA account options, and 401k retirement account access with employer matching. Employees in this role are also entitled to paid sick leave and/or other paid time off as provided by applicable law Compensation.
Required Skills and Experience *
• 3-5+ Years of experience with Validation requirements, knowledge of different types of Validation applications, and compliant validation testing techniques.
• 3-5+ years of experience as a technical business analyst / product analyst in Pharmaceutical industry, demonstrated ability to lead all aspects of Software system life cycle, ability to understand business needs and ensure implementation and adoption of business systems to meet user requirements.
• 2+ years of experience in a GxP laboratory or manufacturing environment within pharmaceutical industry
• Experience in software validation, testing and release management, understanding of GxP requirements, business process analysis and SDLC documentation, documenting and managing business use cases and user requirements
• Experience using KNEAT/eVal, Knowledge of Kneat or similar paperless validation management software (App Change Management)
• Ownership of business requirements / use cases throughout all phases of product lifecycle - drive alignment within the product team and stakeholder groups i.e. Digital Manufacturing Operations (DMO) and Digital Quality and Labs (DQ&L)
• 2-3+ years of experience Commissioning and Qualification, Risk-Based Approach to Commissioning and Qualification.
• Hands-on experience and understanding of automated systems assisting manufacturing, corporate Business systems:
• Knowledge and hands-on experience with relevant industry standards for system validation such as GAMP5, experience writing validation assessment and white paper for validation.
Nice to Have Skills and Experience
• Experience in Pharmaceutical industry and within laboratory / shop floor operations is a strong plus pharmaceutical experience preferred. Manufacturing/Quality/Regulatory and Digital Enablement experience.
• Knowledge of manufacturing sites operations enabling effective and efficient decision making.
• Experience with analytical instruments that are used on the shopfloor such as balances, pH/conductivity. spectrophotometers, or others Experience with lab technology integrations applications such as LabX, Smartline Data Cockpit, or others Experience configuring scientific methods and collaborating with lab personnel to identify requirements
• Experience working in a Product team is a plus, Practice in Agile Methodology and Continuous Improvement, a Digital and Innovative mindset.
• Experience in delivering and/or supporting regulated IT, automation, and/or laboratory systems
• Knowledge of manufacturing sites operations enabling effective and efficient decision making
Job Description *
As an integral part of Digital Manufacturing Division Manufacturing Value Team, the Technical Validation Business Analyst will work on key project initiatives out of the West Point PA Manufacturing site. Instrument Integration is charged with an ownership of business domain expertise & its representation within the overall Product Team in support of our Manufacturing Division’s global shopfloor analytical instruments. The Digital Validation Business Analyst will provide close support for the Digital Validation Product Team. In this role, the BA is responsible for ensuring that released products meet business needs and compliance requirements and help the team achieve its goals. You will define and prioritize requirements (stories) in the backlog and accept requirements (stories) as completed. Additionally, you will work with stakeholders to understand and communicate user needs and assist in Digital Product discovery activities. You will play a critical role in planning, designing, and testing activities and engaging support teams for GxP products. You will also work closely with the Production Support (AMS) team to help sustain the production system. The role requires collaboration with global stakeholders in our Manufacturing Division, Digital Manufacturing Division, Digital Quality Operations, and IT.
