Bachelor's degree in Engineering (Chemical, Biomedical, Biochemical, or similar), Life Sciences, or a related technical field
2-5 years of experience in MSAT, process engineering, or manufacturing processes within a GMP-regulated environment
Working knowledge of process validation concepts, including PV protocols and PPQ
Experience with CDMO or vendor oversight, coordinating sampling and testing
Project management experience or ability to track deliverables and timelines
Strong technical writing skills for drafting protocols and reports
Excellent organization, communication, and collaboration skills
Responsibilities
Meet with stakeholders to gather input and develop PV protocols for Process Performance Qualification (PPQ)
Coordinate execution of PV protocols, including sampling plans and data collection
Partner with internal and external teams to ensure timely sampling and testing
Oversee vendor and CDMO PV activities, tracking milestones and escalating risks
Compile and review PV data for completeness and accuracy, flagging trends
Support documentation and resolution of deviations during protocol execution
Summarize PV protocol execution in final reports for SME review
Maintain protocol and data trackers, ensuring compliance with GMP and regulations
Benefits
High growth potential in a fast-paced, people-focused culture
Competitive pay with performance-based incentives
Company-paid Life, Short-Term, and Long-Term Disability Insurance
Comprehensive Medical, Dental & Vision insurances
Flexible Spending Accounts and Commuter Benefits
Supplemental insurance options available
Health Savings Account
401(k) Retirement Plan with Employer Matching
Generous Paid Time Off and Holidays
Tuition Reimbursement
Team social activities and employee recognition programs
Paid Parental Leave and Bereavement support
Full Job Description
Process Engineer Responsibilities:
Meet with stakeholders and SMEs to gather input and develop PV protocols in preparation for and throughout Process Performance Qualification (PPQ)
Coordinate execution of PV protocols, including sampling plans, testing, data tracking, and data collection
Partner with internal functional groups (such as Manufacturing, Quality, Quality Control, and MSAT) and external CDMOs and contract laboratories to keep sampling, testing, and reporting on schedule
Provide day-to-day oversight of vendor and CDMO PV activities, tracking milestones, deliverables, and open items and escalating risks to SMEs and project leadership
Track and compile PV data, reviewing it for completeness and accuracy and flagging trends or unexpected results to SMEs
Support the documentation and resolution of deviations and discrepancies that arise during protocol execution
Summarize PV protocol execution and results in final reports, and prepare final packages for SME review and approval
Maintain protocol, sampling, and data trackers, communicate status and timelines to project stakeholders, and ensure all activities comply with GMP, internal procedures, and applicable regulatory requirements
Requirements:
Bachelor's degree in Engineering (Chemical, Biomedical, Biochemical, or similar), Life Sciences, or a related technical field
2-5 years of experience in MSAT, process engineering, or manufacturing processes within a GMP-regulated pharmaceutical, biotechnology, or medical device environment
Working knowledge of process validation concepts, including PV protocols, PPQ, and sampling and testing strategies
Experience with CDMO or vendor oversight is valuable, including coordinating sampling, testing, and data collection across internal teams and external partners
Project management experience or demonstrated ability to track deliverables, timelines, and cross-functional action items is valuable
Strong technical writing skills, with experience drafting or contributing to protocols and summary reports
Strong organization, communication, and collaboration skills, with the ability to work with SMEs and cross-functional stakeholders and manage multiple activities and deadlines
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.
National (US) Range
$84,885-$127,144 USD
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
About Verista
Verista is a software company that provides a platform for managing and automating business processes. The company's platform uses artificial intelligence and machine learning to analyze data and optimize workflows. Verista's customers include companies in the healthcare, financial services, and manufacturing industries. The company was founded in 2017 and is headquartered in Palo Alto, California.
