6096 - CQV Process Engineer / Senior 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

The Senior Process Engineer will support the design, installation, startup, and qualification of a biologics formulation, fill, and finish facility. This role is focused on new construction/startup projects, working cross-functionally with Engineering, Manufacturing, Quality, Automation, and external vendors to deliver compliant, operational fill-finish systems. The ideal candidate has hands-on experience with vial and/or prefilled syringe (PFS) filling lines in a GMP environment.

Senior Process Engineer Responsibilities:

• Provide process engineering support for formulation, filling, stoppering, capping, inspection, and packaging operations for biologics
• Support startup and commissioning of new fill-finish facilities, including greenfield or major expansion projects
• Act as process SME for vial and/or prefilled syringe filling lines, including isolators, RABS, and associated support equipment
• Lead or support equipment specification, URS development, vendor selection, FAT/SAT, commissioning, and CQV activities
• Collaborate with Project Management to ensure milestones, schedules, and deliverables are met during construction and startup
• Support process validation activities, including media fills (APS), PPQ, and continued process verification
• Partner with Quality to ensure all activities meet cGMP, FDA, EMA, and ICH requirements
• Support development of process flow diagrams, risk assessments (FMEA), and change control documentation

Requirements:

• Bachelor's degree in Chemical Engineering, Mechanical Engineering, Biomedical Engineering, or related discipline
• 5+ years of experience in biologics formulation, fill, and finish operations
• Direct experience supporting vial and/or prefilled syringe (PFS) filling lines
• Experience working on new facility startup, commissioning, or major capital projects
• Strong understanding of aseptic processing principles and GMP requirements
• Experience supporting CQV activities in a regulated environment
• Ability to work effectively in cross-functional, fast-paced project teams
• Strong technical problem-solving skills
• Hands-on mindset with strong attention to detail

This role requires the ability to be on-site, full-time in Bloomington, IN.

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