6623 - Process Engineer

United States·Novatomid

EngineeringProcess Engineer

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Quick Summary

Key Responsibilities

Meet with stakeholders and SMEs to gather input and develop PV protocols in preparation for and throughout Process Performance

Technical Tools

EngineeringProcess Engineer

Description

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

Responsibilities

~1 min read

→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

~2 min read

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.

*Verista is an equal opportunity employer.

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

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

Location & Eligibility

Where is the job

Novato, United States

On-site at the office

Who can apply

About this job

Pay per year: $84,885–$127,144 a year; 3% below the $109,500 median for Process Engineer jobs on Jobera (329 salaries).
Who can apply: United States
Posted: Today
Employer: has 44 open jobs on Jobera.