Validation Project Lead / Documentation Audit Lead
FST Technical Services —Durham, NC
- Full-time
- Management
- Construction site
- Engineering
13d
Engineering Administrator
AKG of America Inc —Mebane, NC
- PRN
- Mid-level
- Product management
- Organizational skills
- Paid holidays
- Disability insurance
Quick Apply

Discover related jobs

Based on your search for document control jobs.

Systems Administrator III, Health Systems (Epic Prelude or Grand Central or Benefits)
Kaiser Permanente —Greensboro, NC
The Epic Systems Analyst III supports the Patient Access and Hospital Operations Technologies organization by serving as a senior-level subject matter expert…
$89,400 - $115,610 a year
Quick Apply
Senior Implementation Consultant
Relias US —Morrisville, NC
Commanding and driving internal resources across Relias, including but not limited to technical, clinical, change management, and account management teams.
$55,000 - $70,000 a year
Quick Apply

Show more related jobs

Explore jobs in cities nearby

Check out jobs in cities near your current location, Columbus

Document Production Associate (Mon-Fri, 1-10p)
RR Donnelley —Columbus, OH
Skilled in the use MS Office software (Word, Excel, PowerPoint); strong keyboarding and typing skills. RRD’s benefit offerings include medical, dental, and…
$16.59 - $22.50 an hour
Quick Apply
Document Control Specialist II
HNTB Corporation —Columbus, OH
Associate's degree in relevant field and 3 years of relevant experience, or. This opportunity entails being responsible for administering the document lifecycle…
$66,406.79 - $99,610.19 a year
8d

Show more jobs in cities nearby

I want to receive the latest job alert for document control in mebane, nc

By signing in to your account, you agree to SimplyHired's Terms of Service and consent to our Cookie and Privacy Policy.

Explore jobs in more locations

document control jobs near mebane, nc

Project Lead jobs in Durham, NC

Project Lead jobs in Boston, MA

Project Lead jobs in Edinburgh, IN

Project Lead jobs in Huntsville, AL

Remote Project Manager jobs in New York, NY

Project Lead jobs in Remote

Project Coordinator jobs in Washington, DC

Trust Administrator jobs in Boston, MA

Remote Administrator jobs in Tennessee

Nursing Facility Administrator In Training jobs in Louisiana

Arts Administrator jobs in Denver, CO

Arts Administrator jobs in Greensboro, NC

Construction Administrator jobs in New York, NY

Validation Project Lead / Documentation Audit Lead

FST Technical Services -
Durham, NC

Apply Now

Job Details

Full-time
13 days ago

Qualifications

Management
Document control experience within pharmaceutical industry
Pharmaceutical regulatory compliance
Compliance audits & assessments
GMP
Project management experience in manufacturing
Quality control audit
Manufacturing facility experience
Production validation processes
Construction industry experience
Compliance documentation
Auditing experience within manufacturing industry
Leading team collaboration initiatives
Biomedical regulatory compliance
Managing projects
Commissioning phase involvement
Project management experience in construction
FDA regulations
Pharmaceutical manufacturing facility experience

Full Job Description

Validation Project Lead / Documentation Audit Lead

Major Pharmaceutical Facility Construction Project
Location: Durham, NC - FST Life Science office

FST Technical Services is seeking an experienced Validation Project Lead / Documentation Audit Lead to support a large pharmaceutical manufacturing facility construction project.

This role is responsible for establishing a standardized process for the validation of hygienic welding documentation (Isometrics) to ensure compliance with project specifications, applicable codes (e.g., ASME BPE), and industry best practices to support full traceability for hygienic systems..

Responsibilities

Lead documentation audit activities to ensure full traceability of hygienic piping systems.
Manage schedule, priorities, milestones, and deliverables.
Audit weld documentation packages for GMP and Good Documentation Practices (GDP) compliance.
Ensure document traceability.
Coordinate resolution of documentation deficiencies and quality observations.
Partner with Construction Management, Fabricators and Client representatives.
Maintain validation metrics and documentation status reports.
Mentor junior validation specialists and documentation specialists.

Required Qualifications

Bachelor's degree in Engineering, Life Sciences, Biotechnology, Pharmaceutical Sciences, or related technical discipline (or equivalent experience).
8+ years of pharmaceutical validation, CQV, QA, or GMP documentation experience.
3+ years leading validation documentation or CQV teams on large pharmaceutical capital projects.
Strong knowledge of FDA cGMP regulations (21 CFR Parts 210 & 211).
Thorough understanding of Good Documentation Practices (GDP).
Experience supporting Commissioning, Qualification & Validation activities.
Experience preparing projects for client and regulatory audits.
Excellent project management, organization, and communication skills.

Preferred Qualifications

Experience with Traceability Matrices, ALCOA+, Equipment & Utilities Installation Qualification,

Experience with EIDA, Bluebeam, Microsoft Office and SharePoint.

9bvVC78cHP

Apply Now

Refine Your Search

document control jobs in mebane, nc

Validation Project Lead / Documentation Audit Lead

Engineering Administrator

Discover related jobs

Explore jobs in cities nearby

I want to receive the latest job alert for document control in mebane, nc

Explore jobs in more locations

Validation Project Lead / Documentation Audit Lead

Required Qualifications

Preferred Qualifications

Job Seeker Tools

Employer Tools

Browse

Stay Connected