Technical Writer II

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

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The Technical Writer II is a fully competent technical documentation professional 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. The role supports the successful transfer, validation, commercialization, and lifecycle management of manufacturing processes through compliant, effective, and scalable documentation systems. The Technical Writer II partners closely with cross‑functional stakeholders to translate technical, operational, scientific, and regulatory requirements into clear, accurate, and compliant GMP documentation. The role serves as an experienced documentation resource responsible for managing documentation deliverables, facilitating reviews, driving adherence to timelines, supporting knowledge management, and promoting documentation excellence across the organization.

What you will do

• Documentation Lifecycle Management 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.
• Process Validation, Risk Management & Technical Documentation Independently develop and maintain MBPRs, validation protocols and reports, CPV documentation, risk assessments, FMEAs, specifications, process control documents, technology transfer documentation, and technical reports. Support documentation requirements throughout the product lifecycle from technology transfer through commercial manufacturing.
• Cross‑Functional Coordination & Documentation Project Leadership Coordinate documentation deliverables across Manufacturing, Quality, Engineering, MPT, Supply Chain, and Technical Operations. Facilitate review meetings, manage stakeholder feedback, establish timelines, track action items, and drive completion of documentation milestones
• Digital Documentation & Systems Support Support document management systems and digital manufacturing initiatives. Participate in document digitalization, electronic batch record implementation, template standardization, workflow improvements, and automation initiatives.
• Training, Knowledge Management & Documentation Support Provide guidance on GMP documentation standards, templates, document management processes, and systems. Support onboarding and informal mentoring of less experienced writers.
• Continuous Improvement, Compliance & Inspection Readiness Identify opportunities to improve documentation processes, workflows, systems, and standards. Support audit readiness, inspection readiness, regulatory commitments, and quality initiatives.

Qualifications

• Bachelor's Degree Chemistry, Biochemistry, Biotechnology, Pharmaceutical Sciences, Chemical Engineering, Biochemical Engineering, Life Sciences, Technical Communication, or related scientific discipline required
• Master's Degree Scientific, Engineering, Regulatory Affairs, Technical Communication, Business, Project Management, or related discipline preferred
• 2-5 years of relevant experience in pharmaceutical, biotechnology, CDMO, manufacturing, technical operations, validation, technical writing, process support, quality systems, or related GMP disciplines required
• Experience independently authoring, revising, reviewing, and managing GMP documentation preferred
• Experience supporting technology transfer, validation, manufacturing readiness, process improvement, and lifecycle management activities preferred
• Experience utilizing electronic document management systems such as MasterControl or equivalent systems preferred
• Experience coordinating documentation projects, timelines, and cross‑functional deliverables preferred
• Strong understanding of GMP documentation requirements, documentation lifecycle management, and data integrity principles.
• Knowledge of manufacturing processes, technology transfer, process validation, continued process verification, and risk management concepts.
• Ability to independently author, revise, and maintain complex technical and GMP documentation.
• Strong project coordination, organization, and timeline management skills.
• Ability to effectively facilitate document reviews and coordinate input from multiple stakeholders.
• Ability to manage multiple priorities with minimal supervision.
• Commitment to safety, quality, compliance, and continuous improvement.

Base Annual Salary Range:

• Technical Writer I $60,646 - $94,402
• Technical Writer II $68,656 - $94,402

Placement of new hires in these wage ranges is based on several factors including education, skill sets, experience, and training.

Total Rewards

We offer all Team Members a total rewards package including competitive pay, annual performance bonus, a generous benefit package with comprehensive Medical/Dental/Vision coverage, 401(k) plan with employer contribution, and paid vacation, personal and sick days.

Corporate Social Responsibility

Bachem takes responsibility for future generations by a careful handling of resources and avoiding environmental risks. We continually improve our ecological performance and develop and implement new approaches for enhancing employees' environmental awareness. EcoVadis has awarded Bachem Gold Medal status in their assessment of Bachem.

Bachem Americas is an Equal Opportunity Employer

As an equal opportunity employer, we celebrate the diversity of our team and are committed to building an inclusive workplace where individuals are hired and advanced based on merit, skills, and qualifications. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, gender identity or expression, sexual orientation, national origin, genetics, disability, age, veteran status, or other legally protected status.

At Bachem, you'll find a diverse, multicultural team. The(a)in the job title stands forall. We welcome applications from all candidates. What matters are your skills and motivation- regardless of age, gender, background, religion, or sexual orientation.

Please note: unsolicited resumes from recruitment agencies will not be considered.