Specification Development jobs

Responsible for independently authoring, coordinating, implementing, maintaining, and managing GMP documentation supporting manufacturing, technical operations, technology transfer, process validation, product lifecycle management, risk management, and continuous improvement activities.

Compensation

Base Annual Salary Range: Technical Writer I $60,646 - $94,402 Technical Writer II $68,656 - $94,402

Responsibilities

Independently author, revise, review, implement, and maintain GMP documentation supporting manufacturing and technical operations
Manage documentation throughout its lifecycle including initiation, review, approval, implementation, periodic review, revision, and retirement
Ensure compliance with regulatory requirements, customer commitments, company standards, and GMP requirements
Develop and maintain MBPRs, validation protocols and reports, CPV documentation, risk assessments, FMEAs, specifications, process control documents, technology transfer documentation, and technical reports
Coordinate documentation deliverables across manufacturing, quality, engineering, MPT, supply chain, and technical operations

Requirements

Bachelor's Degree in Chemistry, Biochemistry, Biotechnology, Pharmaceutical Sciences, Chemical Engineering, Biochemical Engineering, Life Sciences, Technical Communication, or related scientific discipline
Nice to have: Master's Degree in Scientific, Engineering, Regulatory Affairs, Technical Communication, Business, Project Management, or related discipline
Nice to have: Experience supporting technology transfer, validation, manufacturing readiness, process improvement, and lifecycle management activities
Nice to have: Experience utilizing electronic document management systems such as MasterControl or equivalent systems
Nice to have: Experience coordinating documentation projects, timelines, and cross-functional deliverables

Skills

GMP documentation Process validation Technology transfer MasterControl Project coordination Documentation lifecycle management Risk assessment FMEA Specification development

Benefits

Medical/Dental/Vision coverage
401(k) plan with employer contribution
Paid vacation
Personal and sick days

See full job description