Senior CQV Engineer / Senior Validation Engineer - 5103

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 CQV Engineer Responsibilities:

• You will be responsible for performing quality oversight & approval of validations, change controls, records, & projects to ensure consistent deliver of high quality documents, processes, products, and processes.
• This position is responsible for providing quality support and oversight on product, process, and equipment related changes and implementations (validation & change control). Specifically,
• Provide quality support and oversight (approval) of process and equipment validation and change control records and activities,
• Ensure that facilities, utilities, and equipment (FUE) used in the support of the Quality System are validated and maintained in compliance with regulatory requirements,
• Review documentation (e.g. validation records/reports, change control records, periodic reviews, etc.) for accuracy, clarity, consistency, completeness, and compliance,
• Plan and complete assignments with a wide degree of difficulty while maintaining milestones established in the project schedule,
• Analyze data, procedures, and requirements to ensure quality and compliance,
• Collaborate with alternate functional teams (including but not limited to engineering, operations, regulatory, program management, and other quality teams) to ensure consideration is given to financial and business outcomes when making quality decisions
• Coordinate activities across multiple project groups,
• Accept ownership and responsibility for decisions,
• Provide leadership, guidance, coaching, and training to various functions and colleagues.
• Participate in the development or modification of validation packages and deliverables, including assessments, plans, requirements, and protocols.
• Report unexpected events or issues which occur during validation to project team and management.
• Apply sound, systematic problem-solving methodologies in identifying, investigating, assessing impact, and resolving unexpected events or issues which occur during validation.
• Perform quality oversight & approval of equipment, process, and validation documentation and change control records (e.g. pFMEAs, URSs protocols, reports, SOPs, work instructions, process flow diagrams, ECs, etc.)
• Review documentation for accuracy, clarity, consistency, completeness, and compliance to internal and external requirements for multiple projects
• Drive strategy process validation for new or changing products, processes, facilities, equipment, etc.
• Ensure that appropriate procedures, controls, and recovery plans are incorporated into equipment, system, process, and/or product implementations/changes.
• Work with cross functional teams to ensure quality and compliance requirements are considered during activities (e.g., work with microbiology to ensure appropriate environmental monitoring and that microbiology requirements are considered in product and process development activities)
• Drive to meet validation schedule as aligned with project(s) goals.
• Works independently with objectives given by the Quality Manager.
• Plan and coordinate own work according to higher level project schedules.
• Support (as needed) the investigation, resolution and prevention of product and process nonconformances, CAPA investigations, or other quality system records.
• Identify areas for process improvement and provides supporting information for change, including reasons and justifications.
• Assist team members and cross functional colleagues in meeting their goals by providing coaching and mentoring as needed.
• Participate in or lead teams in supporting quality disciplines, decisions, and practices (e.g., represent the Quality function as a Core Team Member).
• Support projects and Divisional initiatives as identified by management.
• Performs other related duties and responsibilities, on occasion, as assigned.

Requirements

• Must be willing to work onsite in Bloomington, IN
• Bachelor's Degree Engineering or Technical Field or an equivalent combination of education and work experience
• 3-6 Years of relevant role specific experience
• Process Validation experience and demonstrated use of Quality tools/methodologies.
• Detailed knowledge of FDA, GMP, ISO 13485, and ISO 14971.
• Solid communication (written and oral) and interpersonal skills.
• Strong project management and leadership skills, including the demonstrated ability to lead multi-departmental project teams and resolve quality-related issues in a timely and effective manner
• Prior medical device validation experience preferred.
• Experience implementing various product and process improvement methodologies (e.g., Six Sigma and Lean Manufacturing).
• Ability to work within a team and as an individual contributor in a fast-paced, changing environment.
• Ability to leverage and/or engage others to accomplish projects.
• Strong verbal and written communications with ability to effectively communicate at multiple levels in the organization.
• Multitasks, prioritizes and meets deadlines in timely manner.
• Strong organizational and follow-up skills, as well as attention to detail.
• Ability to maintain regular and predictable attendance.

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.

$70,491 - $110,784

*Verista is an equal opportunity employer.