Verista · 18 hours ago
Senior Process Engineer - 5350
Novato, CA
Full-time
Remote
Mid, Senior Level
$88K/yr - $123K/yr
6+ years exp
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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
Qualification
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Required
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
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
Company
Verista
Verista offers transformative compliance, automation, packaging solutions for the life sciences, pharmaceutical and manufacturing.
501-1000 employees
H1B Sponsorship
Verista has a track record of offering H1B sponsorships. Please note that this does not
guarantee sponsorship for this specific role. Below presents additional info for your
reference. (Data Powered by US Department of Labor)
Distribution of Different Job Fields Receiving Sponsorship
Represents job field similar to this job
Trends of Total Sponsorships
2023 (11)
2022 (8)
2021 (2)
Funding
Current Stage
Late StageLeadership Team
Bill Murray
Chief Financial Officer
Recent News
2023-12-22
2023-12-22
Company data provided by crunchbase
