Senior CSV Engineer/Analyst - 4971

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

Senior CSV Engineer/Analyst Responsibilities:

• Direct experience and understanding of complex automated lab systems such as HPLC, GC, TOC, UV/Vis, Plate Readers and automated titrators
• Experience with lab system configuration and operation
• Understanding of system integrations, including but not limited to understanding of how integrations are designed / constructed, data flow from source systems to target systems, typical testing approach for system integrations
• Independently understanding client’s quality standards, cGMP’s, and regulatory standards to support team in compliance of validation effort
• Independent verification of testing against specifications
• Managing and working collaboratively with clients’ quality representative to complete deviation investigation and resolution for problems and issues encountered during execution activities. Includes ability to complete root cause analysis
• Familiarity with bench top analytical equipment and have worked with chromatography and LIMS system sample workflows
• Product Owner/Admin for Micro EM MODA
• Oversee delivery of a validated GMP solution to a global user community
• Collaborate with site laboratory operations subject matter experts (SMEs) to deliver a solution built upon a harmonized business process aligned with quality standards and site-specific monitoring procedures.
• Oversee root cause analysis and vendor collaboration on technical issues to promote solution performance.
• Ability to create a Standard Operating Procedure (SOP) for site master data configuration, migration, and verification.
• Support the creation and delivery of global training materials for EM MODA.
• Create business requirements and user stories, performing product backlog creation and refinement.
• Work with cross-functional teams represented by site, vendor, and global teams to provide on-going support of a user community of practice.
• Technical lead responsible for managing enhancement and bugfix testing, validation, and release of EM MODA

Requirements

• Must be willing to work onsite in Baltimore, MD
• Bachelor’s Degree or equivalent required
• Demonstrated experience in leading CQV activities specific to Process Equipment
• 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
• Demonstrated capability to deliver on the Senior Project Engineer responsibilities
• Ability to mentor and guide less experienced team members
• Ability to communicate effectively with clients
• Proven ability to identify areas of business expansion and report to management team for follow-up
• Ability to lead risk assessment activities to determine project goals for Verista products
• Experience in vision inspection and automation manufacturing environments with demonstrated ability to generate project engineering deliverables independently
• Ability to work independently and as part of a team, with the ability to transition between the two
• Demonstrated capability to deliver on the Project Engineer Responsibilities
• Experience in vision inspection and automation manufacturing environments with the ability to generate project engineering deliverables with support of mentor

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

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.

$80,495 - $116,843

*Verista is an equal opportunity employer.