Technical Writer

United Pharma; New Jersey; On-site; USD 70,000 - 100,000; Full time

Job summary

United Pharma is seeking a Technical Writer - Sterile Operations to support the startup of a new sterile injectable manufacturing suite. The role focuses on developing, revising, and maintaining GMP documentation for sterile manufacturing, including SOPs, MBRs, PBRs, forms, and investigation records.

You will convert technical input from Operations, Quality, Validation, and Engineering SMEs into clear procedures, manage document revisions, and ensure records reflect approved processes and

Qualifications

• 2-5 years of relevant experience, preferably in pharmaceutical or sterile/aseptic manufacturing.
• Experience writing SOPs, batch records, technical reports, deviations, RCA, and CAPA documentation in a cGMP environment.
• Working knowledge of cGMP and sterile/aseptic manufacturing principles.
• Familiarity with isolator technology, VHP decontamination, aseptic filling, and environmental monitoring is preferred.
• Strong technical writing, editing, organization, and attention-to-detail skills.
• Ability to work effectively with Operations, Quality, Validation, and Engineering teams.

Responsibilities

• Develop and update SOPs, forms, and technical documents covering bulk formulation, sterile filtration, filter integrity testing, aseptic filling, VHP decontamination, parts washing/autoclaving, cleaning, and environmental monitoring.
• Convert technical input from Operations, Quality, Validation, and Engineering SMEs into clear, accurate, inspection-ready procedures.
• Manage document revisions, periodic reviews, approvals, and retirement activities.
• Author and maintain Master Batch Records (MBRs) and Master Packaging/Batch Records (PBRs).
• Ensure batch records accurately reflect approved processes, equipment, controls, and critical process parameters.
• Provide writing support for deviations, discrepancies, RCA, CAPA, and investigation reports.

Skills

Technical writing

Editing

Attention to detail

Organization

Cross-functional collaboration

Job description

We are seeking a Technical Writer - Sterile Operations to support the startup of a new sterile injectable manufacturing suite. The facility will support vial, syringe, and cartridge filling using a Groninger UFVN FlexFill line within a SKAN isolator environment.

The selected candidate will develop, revise, and maintain critical GMP documentation, including SOPs, forms, Master Batch Records, packaging/batch records, logs, and investigation documentation supporting sterile manufacturing operations.

Key Responsibilities:

• Develop and update SOPs, forms, and technical documents covering bulk formulation, sterile filtration, filter integrity testing, aseptic filling, VHP decontamination, parts washing/autoclaving, cleaning, and environmental monitoring.
• Convert technical input from Operations, Quality, Validation, and Engineering SMEs into clear, accurate, inspection-ready procedures.
• Manage document revisions, periodic reviews, approvals, and retirement activities.
• Author and maintain Master Batch Records (MBRs) and Master Packaging/Batch Records (PBRs).
• Ensure batch records accurately reflect approved processes, equipment, controls, and critical process parameters.
• Provide writing support for deviations, discrepancies, RCA, CAPA, and investigation reports.

Skills & Qualifications:

• 2-5 years of relevant experience, preferably in pharmaceutical or sterile/aseptic manufacturing.
• Experience writing SOPs, batch records, technical reports, deviations, RCA, and CAPA documentation in a cGMP environment.
• Working knowledge of cGMP and sterile/aseptic manufacturing principles.
• Familiarity with isolator technology, VHP decontamination, aseptic filling, and environmental monitoring is preferred.
• Strong technical writing, editing, organization, and attention-to-detail skills.
• Ability to work effectively with Operations, Quality, Validation, and Engineering teams.