Experience supporting GMP-regulated pharmaceutical, biotech, medical device, or manufacturing environments. * Strong understanding of validation lifecycle principles and documentation requirements.
Experience supporting GMP-regulated pharmaceutical, biotech, medical device, or manufacturing environments. * Strong understanding of validation lifecycle principles and documentation requirements.
... biotech companies to bring their sterile injectable products to market. With facilities in ... The Validation Lead/Associate III, Commissioning Qualification, Validation is a strong individual ...
... biotech companies to bring their sterile injectable products to market. With facilities in ... The Validation Lead/Associate III, Commissioning Qualification, Validation is a strong individual ...
... biotech companies to bring their sterile injectable products to market. With facilities in ... The Validation Lead/Associate III, Commissioning Qualification, Validation is a strong individual ...
... biotech companies to bring their sterile injectable products to market. With facilities in ... The Validation Lead/Associate III, Commissioning Qualification, Validation is a strong individual ...
Experience : 3+ years in validation engineering within pharmaceuticals or biotech. * Skills : Expertise in equipment qualification, Delta V, Upstream/Downstream process validation, GMP compliance ...
Experience : 3+ years in validation engineering within pharmaceuticals or biotech. * Skills : Expertise in equipment qualification, Delta V, Upstream/Downstream process validation, GMP compliance ...
Experience supporting GMP-regulated pharmaceutical, biotech, medical device, or manufacturing environments. * Strong understanding of validation lifecycle principles and documentation requirements.
Experience supporting GMP-regulated pharmaceutical, biotech, medical device, or manufacturing environments. * Strong understanding of validation lifecycle principles and documentation requirements.
Experience supporting GMP-regulated pharmaceutical, biotech, medical device, or manufacturing environments. * Strong understanding of validation lifecycle principles and documentation requirements.
Quick apply
Experience supporting GMP-regulated pharmaceutical, biotech, medical device, or manufacturing environments. * Strong understanding of validation lifecycle principles and documentation requirements.
... biotech companies to bring their sterile injectable products to market. With facilities in ... The Senior Process Validation Engineer is a key member of the Technical Services organization ...
... biotech companies to bring their sterile injectable products to market. With facilities in ... The Senior Process Validation Engineer is a key member of the Technical Services organization ...
... biotech companies to bring their sterile injectable products to market. With facilities in ... The Senior Process Validation Engineer is a key member of the Technical Services organization ...
... biotech companies to bring their sterile injectable products to market. With facilities in ... The Senior Process Validation Engineer is a key member of the Technical Services organization ...
Provide leadership and mentoring to validation engineers and CQV team members. Required Qualifications * Bachelor's degree in Engineering, Life Sciences, Biotechnology, Pharmaceutical Sciences, or ...
Provide leadership and mentoring to validation engineers and CQV team members. Required Qualifications * Bachelor's degree in Engineering, Life Sciences, Biotechnology, Pharmaceutical Sciences, or ...
Senior Engineer, Process Validation
Indianapolis, IN · On-site +1
$100K - $130K/yr
... biotechnology? At Aldevron, one of Danaher's 15+ operating companies, our work saves lives-and we ... The Senior Engineer, Process Validation is responsible for leading & supporting internal and ...
New
Senior Engineer, Process Validation
Indianapolis, IN · On-site +1
$100K - $130K/yr
... biotechnology? At Aldevron, one of Danaher's 15+ operating companies, our work saves lives-and we ... The Senior Engineer, Process Validation is responsible for leading & supporting internal and ...
New
Strategic Account Director
$140K - $190K/yr
... biotech, medical devices. That reputation wasn't built by accident. It was built by people who take ... You'll be working across our CQV, CSV, temperature mapping, and digital validation service lines ...
Strategic Account Director
$140K - $190K/yr
... biotech, medical devices. That reputation wasn't built by accident. It was built by people who take ... You'll be working across our CQV, CSV, temperature mapping, and digital validation service lines ...
Computer Systems Validation Engineer
$75K - $106K/yr
... biotech or pharmaceutical environments preferred over medical device In-depth understanding of GAMP guidelines and FDA regulations (21 CFR 11, 210, 211) Familiarity with S88/S95 batch control ...
Computer Systems Validation Engineer
$75K - $106K/yr
... biotech or pharmaceutical environments preferred over medical device In-depth understanding of GAMP guidelines and FDA regulations (21 CFR 11, 210, 211) Familiarity with S88/S95 batch control ...
... biotech or pharmaceutical environments preferred over medical device In-depth understanding of GAMP guidelines and FDA regulations (21 CFR 11, 210, 211) Familiarity with S88/S95 batch control ...
Quick apply
... biotech or pharmaceutical environments preferred over medical device In-depth understanding of GAMP guidelines and FDA regulations (21 CFR 11, 210, 211) Familiarity with S88/S95 batch control ...
Computer Systems Validation Engineer
$75K - $106K/yr
... biotech or pharmaceutical environments preferred over medical device In-depth understanding of GAMP guidelines and FDA regulations (21 CFR 11, 210, 211) Familiarity with S88/S95 batch control ...
Computer Systems Validation Engineer
$75K - $106K/yr
... biotech or pharmaceutical environments preferred over medical device In-depth understanding of GAMP guidelines and FDA regulations (21 CFR 11, 210, 211) Familiarity with S88/S95 batch control ...
Computer Systems Validation Engineer
Indianapolis, IN · On-site
$75K - $106K/yr
... biotech or pharmaceutical environments preferred over medical device In-depth understanding of GAMP guidelines and FDA regulations (21 CFR 11, 210, 211) Familiarity with S88/S95 batch control ...
Computer Systems Validation Engineer
Indianapolis, IN · On-site
$75K - $106K/yr
... biotech or pharmaceutical environments preferred over medical device In-depth understanding of GAMP guidelines and FDA regulations (21 CFR 11, 210, 211) Familiarity with S88/S95 batch control ...
... biotech companies to bring their sterile injectable products to market. With facilities in ... The Validation Associate I ensures compliance that meets worldwide regulatory agency requirements ...
... biotech companies to bring their sterile injectable products to market. With facilities in ... The Validation Associate I ensures compliance that meets worldwide regulatory agency requirements ...
... biotech companies to bring their sterile injectable products to market. With facilities in ... The Validation Associate I ensures compliance that meets worldwide regulatory agency requirements ...
... biotech companies to bring their sterile injectable products to market. With facilities in ... The Validation Associate I ensures compliance that meets worldwide regulatory agency requirements ...
CQV Lead
Indianapolis, IN · On-site
... CQV, validation, engineering, or startup experience within pharmaceutical, biotech, or GMP-regulated manufacturing environments • Strong experience supporting large-scale capital projects and ...
New
CQV Lead
Indianapolis, IN · On-site
... CQV, validation, engineering, or startup experience within pharmaceutical, biotech, or GMP-regulated manufacturing environments • Strong experience supporting large-scale capital projects and ...
New
Quality Assurance - Computer System Validation (CSV)
Clinton, IN · On-site
$18.25 - $24/hr
Minimum 10 years of experience in a GxP regulated environment (Pharmaceutical, Biotech, or Medical Device), including at least 3-5 years of experience in Computer System Validation (CSV) or Computer ...
Quality Assurance - Computer System Validation (CSV)
Clinton, IN · On-site
$18.25 - $24/hr
Minimum 10 years of experience in a GxP regulated environment (Pharmaceutical, Biotech, or Medical Device), including at least 3-5 years of experience in Computer System Validation (CSV) or Computer ...
Quality Assurance - Computer System Validation (CSV)
Clinton, IN · On-site
$18.25 - $24/hr
Minimum 10 years of experience in a GxP regulated environment (Pharmaceutical, Biotech, or Medical Device), including at least 3-5 years of experience in Computer System Validation (CSV) or Computer ...
Quality Assurance - Computer System Validation (CSV)
Clinton, IN · On-site
$18.25 - $24/hr
Minimum 10 years of experience in a GxP regulated environment (Pharmaceutical, Biotech, or Medical Device), including at least 3-5 years of experience in Computer System Validation (CSV) or Computer ...
Biotech Validation information
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Job description
CQV / Validation Engineer Responsibilities:Commissioning, Qualification & Validation (CQV)
- Execute commissioning, qualification, and validation activities for manufacturing equipment, utilities, facilities, and process systems.
- Author, review, and execute validation lifecycle documentation including:
- Commissioning Protocols
- IQ (Installation Qualification)
- OQ (Operational Qualification)
- PQ (Performance Qualification)
- Validation Summary Reports
- Traceability Matrices
- Risk Assessments
- Support startup and operational readiness activities for new production equipment and manufacturing systems.
- Perform field verification activities, walkdowns, and documentation reviews to ensure systems are installed and functioning according to design requirements.
- Coordinate testing activities with Engineering, Manufacturing, Quality, and Vendor teams.
- Support qualification of production equipment used in pharmaceutical manufacturing operations.
- Troubleshoot qualification and validation issues encountered during equipment startup and testing.
- Review engineering documentation including P&IDs, equipment specifications, drawings, and vendor documentation.
- Ensure equipment and systems meet GMP, regulatory, and internal quality requirements.
- Assist in identifying and resolving deviations, discrepancies, and validation-related issues.
- Ensure all validation activities are executed in accordance with current GMP regulations and company procedures.
- Maintain clear, accurate, and compliant validation documentation.
- Support change controls, deviations, CAPAs, and validation impact assessments as required.
- Participate in audits and inspections by providing validation subject matter expertise.
- Provide technical leadership and mentorship to validation team members.
- Coordinate validation deliverables and execution schedules across multiple systems and workstreams.
- Interface with project leadership to communicate risks, resource needs, and project status.
- Review and approve validation documentation prepared by junior team members.
- Drive resolution of complex qualification and startup challenges.
- Bachelor's degree in Engineering, Life Sciences, or a related technical discipline.
- 3+ years of CQV, Validation, Commissioning, or Qualification experience (Validation Engineer).
- 7+ years of CQV, Validation, or Pharmaceutical Manufacturing experience (Lead Validation Engineer).
- Experience supporting GMP-regulated pharmaceutical, biotech, medical device, or manufacturing environments.
- Strong understanding of validation lifecycle principles and documentation requirements.
- Experience authoring and executing IQ/OQ/PQ protocols.
- Ability to work onsite in Bloomington, Indiana.
- Experience supporting startup of new manufacturing lines, facilities, or capital projects.
- Experience within pharmaceutical manufacturing, sterile manufacturing, biologics, or contract manufacturing environments.
- Familiarity with ISPE, FDA, EU GMP, and GAMP guidance.
- Experience managing deviations, change controls, and risk assessments.
- Strong technical writing and documentation skills.
- Commissioning & Qualification (CQV)
- Equipment Validation
- Manufacturing Systems
- IQ / OQ / PQ Execution
- GMP Compliance
- Technical Writing
- Risk Assessments
- Deviation Management
- Change Control
- Cross-Functional Collaboration
- Startup & Operational Readiness
- Problem Solving & Troubleshooting
About Verista
Sourced by ZipRecruiter
Industry
Pharmaceutical and medicine manufacturing
Company size
201 - 500 Employees
Headquarters location
Fishers, IN, US
Year founded
2020