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Verista · 1 day ago

6096 - CQV Process Engineer / Senior Process Engineer

Bloomington, IN

Full-time

Onsite

Senior Level

$70K/yr - $119K/yr

5+ years exp

Verista is a leading company in the life science industry that focuses on empowering growth and innovation. The Senior Process Engineer will support the design, installation, startup, and qualification of a biologics formulation, fill, and finish facility, ensuring compliance and operational efficiency in collaboration with various teams.

ComplianceHealth CareLife ScienceManufacturingPharmaceutical

H1B Sponsor Likely

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

Qualification

Biologics formulationFilling operationsGMP requirementsCQV activitiesAseptic processingTechnical problem-solvingCross-functional teamworkAttention to detailProject management

Required

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

Benefits

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

Company

Verista

Verista offers transformative compliance, automation, packaging solutions for the life sciences, pharmaceutical and manufacturing.

Founded in 1983

Fishers, Indiana, USA

501-1000 employees

https://www.verista.com/

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

2025 (7)

2024 (4)

2023 (13)

2022 (6)

2021 (1)