Lead CSV Engineer/Analyst

Verista’s 600 experts team up with the world’s most recognizable brands in the life science industry to solve their business needs. The nature of our business is to empower growth and innovation within the scientific community and to help researchers, organizations, and companies solve some of the world’s most pressing healthcare challenges. Verista provides innovative solutions and services that empower informed decision-making and are the result of our significant investment in our people and our capabilities. Our ability to grow is driven by world-class people who thrive in a team environment and share our mission to enable life sciences clients to improve lives. Our talented and dedicated professionals are committed to making an impact every day. Company Culture Guidelines & Values: We empower and support our colleagues We commit to client success at every turn We have the courage to do the right thing We encourage an inclusive environment where our colleagues feel respected, engaged, and challenged. We constantly acquire new skills and learn from our experiences to enhance our collective expertise Lead CSV Engineer/Analyst Responsibilities: Authoring, editing, and executing technical commissioning, qualification and validation documentation for standard equipment/systems/ software, and processes as part of team as directed by the project leader Running test scripts and documenting results Adherence with project schedule for all assigned activities Maintaining clear, detailed records qualification and validation Documenting impact and risk assessments as part of a team Completing user interface testing, software verification, and complete alarm testing on automated systems Developing, reviewing, and executing testing documentation Making recommendations for design or process modification based on test results when executing test scripts General understanding of capital equipment implementation and process knowledge Understanding validation documents, URS, IQ, OQ, PQ Develop and execute protocols for automation systems including DeltaV, BMS, BAS, and EMS. Perform CSV for production equipment and analytical instruments. Collaborate with engineering and CQV teams to align automation validation activities with project timelines. Conduct risk assessments and implement mitigation strategies for computerized systems. Oversee documentation lifecycle for CSV activities, ensuring compliance with regulatory standards. Requirements Must be willing to work onsite in New Brunswick, NJ Bachelor’s degree in Computer Science, Engineering, or a related field. 10+ years of experience in automation and CSV within the pharmaceutical industry. Expertise in DeltaV, Building Management Systems (BMS), BAS, and Environmental Monitoring Systems (EMS). Strong knowledge of GAMP5, FDA regulations, and 21 CFR Part 11. Excellent technical documentation and project management skills. Experience in qualifying "first in kind" equipment Experience with Robotic arms and processing Proficiency using PC and Microsoft Office tools Outgoing personality with strong ability to communicate effectively with peers in clear, concise terms Ability to work as part of a team Strong problem-solving and critical thinking skills Excellent organizational and time management skills Strong attention to detail GMP and Good Documentation Practice Intermediate skills with WORD (authoring/editing large technical documents with styles, tables, TOCs, track changes) Basic skills with EXCEL and PowerPoint Strong interpersonal skills and clear communication capabilities Experience with and tolerance for high levels of challenge and change Experience in GMP regulated environment Proven attention to detail and organization in project work Capable of working on assigned tasks without mentorship Benefits Why Choose Verista? High growth potential and fast-paced organization with a people-focused culture Competitive pay plus performance-based incentive programs Company-paid Life, Short-Term, and Long-Term Disability Insurance. Medical, Dental & Vision insurances FSA, DCARE, Commuter Benefits Supplemental Life, Hospital, Critical Illness and Legal Insurance Health Savings Account 401(k) Retirement Plan (Employer Matching benefit) Paid Time Off (Rollover Option) and Holidays As Needed Sick Time Tuition Reimbursement Team Social Activities (We have fun!) Employee Recognition Employee Referral Program Paid Parental Leave and Bereavement For more information about our company, please visit us at Verista.com (https://apply.workable.com/verista/) For US geography, the salary range for this position is shown below. The actual salary is dependent upon a variety of job-related factors such as professional background, training, work experience, location, business needs, market demand, and competitive market practice. Therefore, in some circumstances, the actual salary could fall outside of this expected range. This salary range is subject to change and may be modified in the future. $87,780 - $138,481 *Verista is an equal opportunity employer.