Computer Systems Validation Engineer (Delta V)

Arcadis is the world's leading company delivering sustainable design, engineering, and consultancy solutions for natural and built assets. We are more than 36,000 people, in over 70 countries, dedicated to improving quality of life. Everyone has an important role to play. With the power of many curious minds, together we can solve the world’s most complex challenges and deliver more impact together. Arcadis is seeking a CSV engineer to support validation activities for process manufacturing in the Biotech and pharmaceuticals. The candidate must have experience with Delta V and be an SME level of this platform. This role is to identify or create industry best practices and implement these within the framework of existing GAMP regulations. Responsibilities for the CSV engineer will include risk assessing systems, reviewing change requests and test scripts, drafting protocols and initiation, and reviewing GMP documentation revisions as well as ownership of department procedures. Responsibilities Provide technical support for ensuring that current versions of the Computer System are qualified through verification and maintained in a qualified state Accurately record data and performing statistical analysis where applicable during execution Adhere to company procedures and government regulations such as Good Documentation Practices (GDP), GAMP and 21 CFR part 11 when executing protocols Document deviations and non-conformances that occur as a result of the qualification Collaborate with Management, Developers, Implementation, business development and client representatives to meet deliverable(s) Route, Approve, Develop and Revise Requirement Specifications, Test Scripts, Validation Master Plans, supporting documentation for validation, admin manuals and software documentation where applicable Coordinate with reviewers and approve to finalize documentation Perform a review of quality systems and manufacturing data, summarize and draw conclusions to be included in individual product assessments Execute Qualification Protocols Track and communicate progress of deliverable(s) Communicate complications or issues in the validation process Other duties as assigned Qualifications & Experience Bachelor's Degree in engineering or related field Minimum 3 year of validation related experience Knowledge of writing and reviewing validation documentation Good understanding of IQ, OQ, PQ, RTM, Test Scripts, Summary Reports, etc Strong Attention to Detail Self-motivated and reliable Knowledge of PC computer operating systems and the Microsoft Office suite Strong written and oral communication skills Ability to provide legal US work authorization documents required. Will consider US domestic travelers and relocation. Arcadis offers benefits for full time and part time positions. These benefits include medical, dental, and vision, EAP, 401K, STD, LTD, AD&D, life insurance, paid parental leave, reward & recognition program and optional benefits including wellbeing benefits, adoption assistance and tuition reimbursement. We offer nine paid holidays and 15 days PTO that accrue per year. Salaries will vary and are based on several factors, such as experience, education, budget, internal equity, project and location. Our Commitment to Equality, Diversity, Inclusion & Belonging We want you to be able to bring your best self to work every day which is why we take equality and inclusion seriously and hold ourselves to account for our actions. Our ambition is to be an employer of choice and provide a great place to work for all our people. We are an equal opportunity and affirmative action employer. Women, minorities, people with disabilities and veterans are strongly encouraged to apply. We are dedicated to a policy of non-discrimination in employment on any basis including race, creed, color, religion, national origin, sex, age, disability, marital status, sexual orientation, gender identity, citizenship status, disability, veteran status, or any other basis prohibited by law. #J-18808-Ljbffr