GMP Technical Writer II: Documentation Lifecycle

Bachem; Vista (CA); In loco; USD 61.000 - 94.000; Tempo pieno

Vantaggi offerti da questo lavoro

Competitive pay

Annual bonus

Medical coverage

Dental coverage

Vision coverage

401(k) plan

Paid vacation

Personal days

Sick days

Descrizione del lavoro

Bachem Americas is seeking a Technical Writer II to independently author, revise, and manage GMP documentation across Manufacturing and Technical Operations. You will coordinate with Quality, Engineering, and Supply Chain to ensure timely reviews and compliant deliverables.

The role emphasizes documentation standards, knowledge management, and involvement in technology transfer, process validation, and continuous improvement initiatives within a fast‑paced biotech environment.

Competenze

• Bachelor’s degree in a scientific discipline related to pharmaceuticals required.
• Master’s degree in a related discipline preferred.
• 2–5 years in GMP documentation or related fields required.
• Experience authoring/revising GMP docs and managing lifecycle.

Mansioni

• Author, revise, review, implement, and maintain GMP documentation across Manufacturing and Technical Operations.
• Develop validation and risk documentation, tech reports, and tech transfer docs.
• Coordinate documentation milestones with cross‑functional teams; manage timelines and reviews.
• Support digital documentation systems, electronic batch records, and template standardization.
• Provide guidance on GMP documentation standards and onboarding of junior writers.
• Support audit readiness and continuous improvement initiatives.

Conoscenze

GMP documentation

Cross-functional coordination

Project coordination

Documentation standards

Knowledge management

Formazione

Bachelor’s in Chemistry/Life Sciences/Tech Comm

Master’s in Scientific/Engineering/Regulatory

Strumenti

MasterControl

Descrizione del lavoro

Bachem Americas is seeking a Technical Writer II to independently author, revise, and manage GMP documentation across Manufacturing and Technical Operations. You will coordinate with Quality, Engineering, and Supply Chain to ensure timely reviews and compliant deliverables.

The role emphasizes documentation standards, knowledge management, and involvement in technology transfer, process validation, and continuous improvement initiatives within a fast‑paced biotech environment.