GMP Manufacturing Documentation Consultant

Piper Companies; Ridgefield (NJ); On-site; USD 157,597,440 - 186,251,520; Full time

Job summary

Piper Companies is seeking two GMP Manufacturing Documentation Consultants to join a 12-month, on-site engagement in Ridgefield, NJ. The role centers on authoring and maintaining Master Batch Records (MBRs) and other GMP documentation for a sterile injectable program.

Ideal candidates have hands-on MBR experience in aseptic/pharmaceutical environments, solid knowledge of cGMP/GDP/ALCOA+ data integrity, and advanced MS Word skills. Onsite work Monday through Friday with DOE pay rates.

Qualifications

• Bachelor's degree in Engineering, Life Sciences, or related technical discipline.
• Minimum 5 years of experience supporting GMP pharmaceutical manufacturing.
• Minimum 3 years authoring or revising Master Batch Records (MBRs) or Manufacturing Instructions.
• Direct experience supporting sterile injectable, aseptic, biologics, or fill-finish manufacturing.

Responsibilities

• Author, revise, and maintain GMP manufacturing documentation, including Master Batch Records (MBRs), SOPs, forms, specifications, and logbooks.
• Collaborate with cross-functional Subject Matter Experts (Manufacturing, MSAT, Engineering, Quality, Validation, and Operations) to gather technical information and accurately document manufacturing processes.
• Coordinate document reviews, reconcile reviewer comments, facilitate review meetings, and drive documentation through approval workflows.
• Support documentation throughout engineering, media fill, clinical, PPQ, and commercial manufacturing activities.
• Ensure all documentation complies with cGMP, GDP, ALCOA+ Data Integrity principles, and internal documentation standards.
• Identify documentation gaps, inconsistencies, and process discrepancies before manufacturing execution.
• Perform advanced document formatting, editing, proofreading, and template management using Microsoft Word.
• Track documentation status, review cycles, approvals, and project milestones while communicating progress and risks to project leadership.

Skills

GMP documentation

Technical writing

Attention to detail

Cross-functional collaboration

Microsoft Word (advanced)

Education

Bachelor's degree in Engineering, Life Sciences, or related

Tools

Microsoft Word

Job description

GMP Manufacturing Documentation Consultant

Location: Ridgefield, NJ (100% Onsite)

Duration: 12-Month Contract

Openings: 2

Pay Rate: $55/hr-65/hour (DOE)

Our client, a leading global pharmaceutical services organization, is seeking two experienced GMP Manufacturing Documentation Specialists to support a high-profile sterile injectable manufacturing program. This is a long-term onsite consulting opportunity supporting technical transfer activities for commercial pharmaceutical manufacturing.

This position is ideal for professionals with hands‑on experience authoring Master Batch Records (MBRs) and GMP manufacturing documentation within a sterile injectable or aseptic pharmaceutical environment.

Responsibilities

• Author, revise, and maintain GMP manufacturing documentation, including Master Batch Records (MBRs), SOPs, forms, specifications, and logbooks.
• Collaborate with cross-functional Subject Matter Experts (Manufacturing, MSAT, Engineering, Quality, Validation, and Operations) to gather technical information and accurately document manufacturing processes.
• Coordinate document reviews, reconcile reviewer comments, facilitate review meetings, and drive documentation through approval workflows.
• Support documentation throughout engineering, media fill, clinical, PPQ, and commercial manufacturing activities.
• Ensure all documentation complies with cGMP, Good Documentation Practices (GDP), ALCOA+ Data Integrity principles, and internal documentation standards.
• Identify documentation gaps, inconsistencies, and process discrepancies before manufacturing execution.
• Perform advanced document formatting, editing, proofreading, and template management using Microsoft Word.
• Track documentation status, review cycles, approvals, and project milestones while communicating progress and risks to project leadership.

Required Qualifications

• Bachelor's degree in Engineering, Life Sciences, or a related technical discipline (or equivalent industry experience).
• Minimum 5 years of experience supporting GMP pharmaceutical manufacturing.
• Minimum 3 years of experience authoring or revising Master Batch Records (MBRs) or Manufacturing Instructions.
• Direct experience supporting sterile injectable, aseptic, biologics, or fill-finish manufacturing.
• Strong understanding of cGMP, Good Documentation Practices (GDP), and ALCOA+ Data Integrity principles.
• Advanced Microsoft Word skills, including complex formatting, templates, styles, tracked changes, tables, pagination, headers/footers, and document management.
• Exceptional proofreading, attention to detail, and technical writing skills.
• Experience supporting technical transfer, process validation, PPQ, or commercial manufacturing documentation is highly preferred.

Preferred Experience

• Sterile injectable manufacturing
• Aseptic processing
• Technical transfer projects
• Master Batch Record (MBR) development
• Manufacturing Instructions
• Pharmaceutical manufacturing documentation
• Engineering, Clinical, Media Fill, and PPQ campaign support

Work Arrangement: This is a 100% onsite position in Ridgefield, NJ. Candidates must be able to work onsite Monday through Friday.

If you have a strong background in GMP manufacturing documentation and Master Batch Record authoring within a sterile injectable environment, we'd like to hear from you.

This job opens for applications on 7/17/2026. Applications for this job will be accepted for at least 30 days from the posting date.

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