Verista, Inc.
6096 - CQV Process Engineer / Senior Process Engineer
Verista, Inc., Bloomington, Indiana, United States, 47401
6096 - CQV Process Engineer / Senior Process Engineer
Bloomington, IN
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
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.
National (US) Range
$70,491 - $118,941 USD
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.
Supplemental Life, Hospital, Critical Illness and Legal Insurance
Health Savings Account
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.
*Verista is an equal opportunity employer.
#J-18808-Ljbffr
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
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.
National (US) Range
$70,491 - $118,941 USD
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.
Supplemental Life, Hospital, Critical Illness and Legal Insurance
Health Savings Account
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.
*Verista is an equal opportunity employer.
#J-18808-Ljbffr