About Epista
Epista Life Science is growing, and we are looking to add Computer System Validation Leads to our team in Stockholm and Skåne areas!
Epista Life Science (Epista) is a trusted consulting company specializing in business process and IT services for the Life Sciences industry. Since our establishment in 2009 Epista has grown remarkably, expanding our services across Denmark, Sweden, Switzerland, Germany and US. Throughout our journey, we have consistently maintained outstanding employee and customer satisfaction. In 2022, we partnered with FSN Capital Partners, reinforcing our commitment to developing a global services platform dedicated to Life Science companies. With FSN onboard, we are looking forward to exciting market expansions as well as merge & acquisition activities.
About the Job
We are looking to add Validation Leads to our team to help guide our customers through times of change and support them in implementation and operations of Business Applications.
Are you passionate about quality assurance for Business Applications? Would you find it interesting to develop and define best practices for validation of Business Applications and IT infrastructure, bringing your innovative spirit to our organization? Then you could be our new colleague - read more and apply!
Depending on your expertise, you may work with:
- Perform IT/QA readiness assessments and create Validation Strategies
- System Implementation and support – take the role as Validation Lead in implementation and support projects. Planning, executing, supporting validation activities
- Validation Advisory – act as SME for advisory within CSV and CSA
- Cloud Validation – Set Cloud Control Strategies and Cloud Vendor Management
Your Qualifications
- At least 5 years of experience of in IT compliance, computer system validation or similar in the Life Science industry
- Experience in IT QA/QC in the pharmaceutical industry
- Knowledge of GAMP5, FDA CFR 21 Part 11, EU GMP Guide Annex 11
- High level of expertise in at least one of the following:
- CSV
- CSA
- Strong consultancy mindset including excellent communication and presentation skills
- Consulting skills, ability to identify and solve problems, provide guidance and support. This requires both analytical and creative thinking, as well as the ability to communicate effectively with clients
- Ability to work on multiple smaller projects at the same time and properly prioritize actions
- Outgoing personality that can facilitate working sessions with various business stakeholders
- A desire to continuously improve your clients, your colleagues, your company, and yourself
- You’re trustworthy, have a high degree of situational awareness, and a flair for communicating with a variety of personalities. This is important because it ensures your image as a credible partner for Epista’s clients
- Experience with Business Applications Validation would be considered as advantage
On a typical day you might ...
As a Computer System Validation Lead at Epista, you’ll be a part of our highly skilled team working at the intersection of business, compliance, and IT.
- You’ll be involved in a wide variety of projects, primarily focusing on acting as Validation Lead in Business Application implementation and operations projects and assignments, where you will contribute with your knowledge and expertise. Your daily activities might include:
- Taking Validation Lead role in large Business Application implementation projects, providing customers with strategic advice on compliance with regulatory requirements, audits and process improvements of IT systems, ongoing maintenance, and operation
- Meeting with client’s Business owners, Quality process experts, and key Quality stakeholders to identify requirements, gaps, issues and provide guidance
- Work collaboratively across functions with stakeholders and vendors to plan, coordinate and execute Business Application validation activities
- Preparation and moderation of workshops with cross-functional participants
- Being a communication bridge between departments (IT, Business, Quality)
- Development of validation strategies, prioritizing tasks, projects, and efforts
- Support for client in relation to system validation documents
- Screening of IT application vendors, performing functionality evaluations, and giving final system recommendations
- Evaluating vendor assessment and vendor documentation
- Supporting customers throughout a system implementation, so they can make the right configuration/system design decisions
- Drafting system operational Governance documents to secure efficient and compliant management of validated system
- Share your experiences and lessons learned with the Epista team to make sure we are all continuously improving
- Create overall compliance and validation strategies on both project and company level
- Independently orchestrating and managing validation/qualification projects
- Participating in projects as a Validation & Compliance Advisor to ensure compliance and documentation requirements are met.
We will only be considering candidates residing in Sweden, as well as being eligible to work in Sweden.
Why work at Epista
At Epista, we consistently work together to unlock each consultant’s potential to continuously improve.
Our unique team spirit makes a positive impact – on our team, our clients, and the Life Science industry. Here, you’re never alone. We all work together for everyone’s success. And each individual is strengthened by the knowledge of the group. It´s not just something we say – it´s how we are a team!
Epista offers exciting challenges, great career opportunities and an attractive working environment with talented and dedicated colleagues. At the same time, you get into a company that emphasizes trust, knowledge sharing and teamwork.
Please submit your resume and a max. 8-line cover letter outlining your relevant experience and why you are interested in this role. We look forward to hearing from you.
NOTE: In line with the Swedish Law of discrimination, Epista Life Science Sweden AB will store relevant information for 2 years to be able to document a fair recruitment process for anyone applying for a role in Epista Life Science Sweden AB.
