Validation & Engineering Group, Inc.
ATL01-052225 Project Manager Biotech CQV
Validation & Engineering Group, Inc. - Indianapolis, Indiana, us, 46262
Work at Validation & Engineering Group, Inc.
Overview
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Overview
ATL01-052225 Project Manager Biotech CQV
ATL01-052225 Project Manager Biotech CQV
4 weeks ago Be among the first 25 applicants Get AI-powered advice on this job and more exclusive features. Validation & Engineering Group, Inc. (V&EG)
is a leading services supplier providing solutions for the Pharmaceutical, Biotechnology, Chemical, Food, and Medical Device industries in the following areas: Laboratory, Compliance, Computer, Engineering, Project Management, Validation, and other services.
We are seeking a talented, dedicated individual committed to working under the highest ethical standards for the following position:
Project Manager
We are currently seeking an experienced
Project Manager
to lead commissioning and qualification (C&Q) activities for a large-scale GMP facility. The selected candidate must be available to work in
production, packaging, and construction areas , in compliance with safety and quality procedures.
Responsibilities
Oversee the full lifecycle of CQV deliverables including protocol planning, execution, and closure. Develop a detailed Gantt chart for protocol development and execution; provide schedule adherence metrics as part of a weekly status report. Manage the CQV resource plan and coordinate across Engineering, QA, Operations, and Digital stakeholders. Escalate technical and quality-related risks impacting scope, schedule, or budget. Lead the resolution of deviations and discrepancies during commissioning and qualification. Ensure alignment with corporate standards and best practices throughout C&Q phases. Oversee turnover documentation and ensure proper archival of validation records.
Qualifications
Bachelor’s degree in engineering, life sciences, or related field. Minimum 10 years of project management experience in GMP manufacturing environments. Experience leading commissioning and qualification of drug product manufacturing areas (fill/finish, packaging, utilities, automation). Strong working knowledge of cGMPs, FDA/EU regulations, and validation lifecycle. Proficiency in project management tools (e.g., MS Project, Excel). PMP certification preferred. Excellent leadership, communication, and problem-solving skills.
Seniority level
Seniority level Mid-Senior level Employment type
Employment type Full-time Job function
Job function Strategy/Planning and Information Technology Referrals increase your chances of interviewing at Validation & Engineering Group, Inc. by 2x Sign in to set job alerts for “Project Manager” roles.
Indianapolis, IN $120,000.00-$150,000.00 14 hours ago Indianapolis, IN $90,000.00-$115,000.00 1 week ago Project Manager – Capital Projects (Life Sciences, Greenfield Construction)-Indianapolis
Greater Indianapolis $85,000.00-$95,000.00 1 week ago Greater Indianapolis $85,000.00-$115,000.00 3 weeks ago Project Director (On-site) - Indianapolis, Indiana
Indiana, United States $60.00-$65.00 2 weeks ago Indianapolis, IN $125,000.00-$140,000.00 1 day ago Indianapolis, IN $130,000.00-$160,000.00 6 days ago Indianapolis, IN $24.00-$35.00 3 weeks ago Indiana, United States $89,500.00-$141,100.00 2 weeks ago Indianapolis, IN $115,000.00-$130,000.00 2 weeks ago We’re unlocking community knowledge in a new way. Experts add insights directly into each article, started with the help of AI.
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ATL01-052225 Project Manager Biotech CQV
4 weeks ago Be among the first 25 applicants Get AI-powered advice on this job and more exclusive features. Validation & Engineering Group, Inc. (V&EG)
is a leading services supplier providing solutions for the Pharmaceutical, Biotechnology, Chemical, Food, and Medical Device industries in the following areas: Laboratory, Compliance, Computer, Engineering, Project Management, Validation, and other services.
We are seeking a talented, dedicated individual committed to working under the highest ethical standards for the following position:
Project Manager
We are currently seeking an experienced
Project Manager
to lead commissioning and qualification (C&Q) activities for a large-scale GMP facility. The selected candidate must be available to work in
production, packaging, and construction areas , in compliance with safety and quality procedures.
Responsibilities
Oversee the full lifecycle of CQV deliverables including protocol planning, execution, and closure. Develop a detailed Gantt chart for protocol development and execution; provide schedule adherence metrics as part of a weekly status report. Manage the CQV resource plan and coordinate across Engineering, QA, Operations, and Digital stakeholders. Escalate technical and quality-related risks impacting scope, schedule, or budget. Lead the resolution of deviations and discrepancies during commissioning and qualification. Ensure alignment with corporate standards and best practices throughout C&Q phases. Oversee turnover documentation and ensure proper archival of validation records.
Qualifications
Bachelor’s degree in engineering, life sciences, or related field. Minimum 10 years of project management experience in GMP manufacturing environments. Experience leading commissioning and qualification of drug product manufacturing areas (fill/finish, packaging, utilities, automation). Strong working knowledge of cGMPs, FDA/EU regulations, and validation lifecycle. Proficiency in project management tools (e.g., MS Project, Excel). PMP certification preferred. Excellent leadership, communication, and problem-solving skills.
Seniority level
Seniority level Mid-Senior level Employment type
Employment type Full-time Job function
Job function Strategy/Planning and Information Technology Referrals increase your chances of interviewing at Validation & Engineering Group, Inc. by 2x Sign in to set job alerts for “Project Manager” roles.
Indianapolis, IN $120,000.00-$150,000.00 14 hours ago Indianapolis, IN $90,000.00-$115,000.00 1 week ago Project Manager – Capital Projects (Life Sciences, Greenfield Construction)-Indianapolis
Greater Indianapolis $85,000.00-$95,000.00 1 week ago Greater Indianapolis $85,000.00-$115,000.00 3 weeks ago Project Director (On-site) - Indianapolis, Indiana
Indiana, United States $60.00-$65.00 2 weeks ago Indianapolis, IN $125,000.00-$140,000.00 1 day ago Indianapolis, IN $130,000.00-$160,000.00 6 days ago Indianapolis, IN $24.00-$35.00 3 weeks ago Indiana, United States $89,500.00-$141,100.00 2 weeks ago Indianapolis, IN $115,000.00-$130,000.00 2 weeks ago We’re unlocking community knowledge in a new way. Experts add insights directly into each article, started with the help of AI.
#J-18808-Ljbffr