6623 - Process 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

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.

*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

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For more information about our company, please visit us at Verista.com