Senior Process Engineer / Senior Process Engineer 2 - 5350

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 Process Engineer 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
• Responsible for general oversight of the Process Performance Qualification efforts at the client site
• Ensure maintenance/required control of records of qualification and validation, Change Controls, Risk Assessments and CAPAs for future compliance audits
• Provide technical guidance and leadership to lesser experienced team members
• Execute process development, scale-up and validation activities in alignment with regulations and quality requirements

Requirements

• Strong understanding of biological process validation activities including drug substance manufacturing processes, drug product filling processes, process simulations (media fills), filtration, mixing, sterilization, lyophilization, and completion of validation risk assessments and evaluations
• Demonstrated experience developing and executing Process Validation Protocols
• High level understanding of Process Performance Qualification processes
• Excellent technical writing abilities

• Ability to mentor and guide lesser 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
• Strong understanding of the three stages of Process Validation: Process Design, Quality Control, and Continuous Process Verification
• Obvious business maturity and interpersonal skills to be able to effectively communicate and collaborate.
• Experience and capability of effectively communicating requirements (written and orally) with rationale to different levels of the client’s organization
• Intermediate Microsoft Project capabilities
• 6-10 years of relevant role specific experience
• 6-10 years of industry experience

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