Search Jobs
Validation Engineer
852 Winter Street Waltham, MA 02451 US
Job Description
The holder of this position is charged with supporting computer system/computerised equipment validation activities and ensuring compliance with policies and procedures. Position scope includes local and global enterprise systems as well as SaaS (Software as a Service) solutions. This role will report into the Manager of Validation.
• Perform validation activities supporting requirements gathering, validation planning, design qualification, authoring test plans and test scripts, execution of test scripts, discrepancy management, and authoring system description and validation summary reports.
• Perform system-based risk assessments in determining GxP applicability of the system, associated risk and resulting validation activities per risk.
• Support Validation Team on all aspects of the computer system/computerised equipment lifecycle during projects and operational phase, including but not limited to development, review and execution of validation documentation.
• Provide validation support during the operational phase by performing change impact assessments, determine the required level of testing, authoring and executing test scripts related to the change and change qualification report.
• Support periodic review of computer systems.
• Support periodic user access review of computer systems/computerised equipments.
• Support business administration of the electronic system (ValGenesis) used for validation lifecycle management.
• Support training of end users on the electronic system (ValGenesis) used for validation lifecycle management.
• Support management of Validation Templates in ValGenesis in terms of authoring/updating templates.
ACADEMIC/TECHNICAL QUALIFICATIONS:
? Bachelor’s degree in a Science or Engineering discipline with 5 years relevant experience in computer system validation.
SPECIALIST/TECHNICAL QUALIFICATIONS/KNOWLEDGE:
• Experience computer systems supporting R&D functions like Clinical, Pharmacovigilance/Drug Safety, Medical Affairs, Supply Chain, Regulatory Affairs and Quality Assurance is a plus
• Experience with ValGenesis is a plus
• Practical experience with quality risk management and risk-based validation approaches.
• Knowledge of cGMP regulations and guidelines including but not limited to U.S. Code of Federal Regulations 21 CFR Part 11 and Part 211, EudraLex Volume 4 and Annex 11, and ICH Q7, Q8, Q9 and Q10. Understanding of industry standards and best practices for computer system validation such as GAMP 5 and ASTM E2500
ABILITIES AND JUDGEMENT:
? Ability to objectively review.
? Ability to make judgements in the wider context of quality/compliance
? Ability to perform effective trouble shooting
? Ability to collaborate and work with cross-functional teams
? Ability to manage high volume of simultaneous projects/validation activities
Pay ranges between $55-65/hr based on experience
Equal Opportunity Employer: We are proud to be an equal opportunity employer. We welcome and encourage applications from all qualified candidates regardless of race, sex, gender identity or expression, disability, age, religion or belief, sexual orientation, or any other characteristic protected by applicable laws and regulations. It is our policy not to discriminate against any applicant or employee, and we are committed to fostering a diverse, inclusive, and respectful work environment across all locations in which we operate. We believe that diversity, equity, and inclusion are fundamental to our mission and enhance our ability to serve clients globally. If you have a disability or require any reasonable accommodations during the application or interview process, please inform your recruiter or contact us directly so that we can explore the appropriate arrangements.
Fraud Alert: Candidate safety is a top priority at Planet Pharma. The industry has seen an increase in people falsely representing themselves as recruiters to gather personal information from job seekers. For your safety, do not provide sensitive data to anyone you have not spoken with thoroughly, never provide banking information during the application process and always double check the email address of the Recruiter to ensure it’s from an official Planet Pharma domain (@planet-pharma.com, @planet-pharma.co.uk, and @ppgadvisorypartners.com) and not a domain with an alternative extension like .net, .org or .jobs.
Share This Job:
Related Jobs:
About Waltham, MA
Are you sure you want to apply for this job?
Please take a moment to verify your personal information and resume are up-to-date before you apply.