5896 - Senior Process Engineer 2 / Senior CQV Engineer
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
Senior Process Engineer 2 Responsibilities:
- Meet with client stakeholders and SMEs to develop Process Validation (PV) protocols in preparation for and throughout Process Performance Qualification (PPQ)
- Coordinate execution of PV protocols, including sampling, testing, data tracking, and data collection with various internal functional groups and external contract labs
- Summarize execution of PV protocols in final reports and prepare final packages for SME review and approval
- Manage the responsibilities on multiple simultaneous projects and/or clients
- Drive the activities as client facing leader and responsible party.
- Act as the defined point of escalation and issue management on client projects
Requirements:
- Ability to take independent leadership role on project(s)
- Coordination and direction of process validation activities involving cross functional teams including Manufacturing, Process Sciences, Process Development, Quality Control, Quality Assurance, Regulatory Affairs, and others
- Some trips to Novato, CA site 1 or 2 x a year may be necessary to oversee execution
- Proven ability to identify areas of business expansion and initiate technical discussion on Verista solutions for business expansion
- Demonstrated project leadership capabilities
- Demonstrated experience with various stages of clinical and commercial manufacturing in a Quality and/or Process Sciences Role
- Strong Understanding of process fundamentals and qualification/ validation requirements for the following:
- Small molecule chemical synthesis
- Monoclonal antibody or protein biomanufacturing
- Cell therapy and regenerative medicine
- Sterile drug product fill/finish
- Analytical QC laboratories
- Computer System
- Packaging
- Ability to architect Process implementations and execute against complex project tasks.
- Advanced Microsoft Project capabilities.
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
Verista collects and processes personal data in accordance with applicable data protection laws. If you are a California Job Applicant, see the privacy notice for further details. For more information about our company, please visit us at Verista.com Apply tot his job Apply To this Job