Description
Verista’s 500 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
Job Overview:
The
Senior CQV Engineer will play a critical role in the successful startup and qualification of a new early-phase clinical biomanufacturing facility, encompassing cleanrooms, utilities, and a wide range of systems and equipment. This position is responsible for planning, executing, and documenting commissioning, qualification, and validation (CQV) activities to ensure all systems meet stringent regulatory and client-specific requirements
Senior CQV Engineer Responsibilities:
- Authoring, editing, and executing technical commissioning, qualification and validation documentation for facilities, utilities, and standard equipment/systems/software
- Actively consulting clients on regulatory validation processes and standard industry acceptable practices
- Collaborating with cross-functional teams including Manufacturing, Facilities, Quality Control and Quality Assurance to ensure validation activities are properly scoped and executed
- Taking independent leadership role on project(s)
- Managing and working collaboratively with clients’ quality representative to complete deviation investigation and resolution for problems and issues encountered during execution activities- including ability to complete root cause analysis.
Job Qualifications:
- Bachelor’s degree in engineering, Life Sciences, or a related field
- 5+ years of relevant experience in validation within a regulated industry (e.g., pharma, biotech)
- Experience with facility, utility, equipment, and computer system validation. Preferably in start-up of early-phase clinical biomanufacturing facilities
- Strong knowledge of validation principles, cGMP, FDA regulations (21 CFR Part 11, Part 210/211), and industry guidelines (e.g., ISPE, GAMP)
- Experience working with start-up clients, without well established company procedures and standards
- Excellent documentation, analytical, and problem-solving skills
- Ability to work independently and as part of a team
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.
*Verista is an equal opportunity employer.National (US) Range$70,491 - $118,062USD
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
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