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We are looking for an Engineering - Technical Writer - Exempt for a very important client.

Job Description -

Responsibilities may include the following and other duties may be assigned.

· Plan, research, develop, and write medical device labeling, and manage labeling deliverables as part of cross-functional project teams under general supervision.

· Simultaneously manage up to two labeling updates and one small, new-product-introduction project that involves multiple labeling pieces.

· Understand and adhere to all quality management system documents and product commercialization procedures applicable to labeling development.

· Conducts interviews with various users and technical staff to gather data for documentation.

· Recommends formats responsive to technical and customer requirements.

· Assist in providing documentation for CAPAs, and departmental and business-unit audits.

· Contribute to time and cost estimates for labeling deliverables for project teams.

· Develop illustrations in cooperation with professional illustrators.

· Participate on department and business-unit initiatives.

· Oversee Engineering Change Order process for labeling.

· Coordinate translations and track the status of translations.

· Complete labeling proofs, develop documentation for regulatory submissions, and carry out other tasks as assigned.

The 3 main responsibilities/day to day activities required for this role:

Update product manuals to align with cross-functional feedback, standards compliance, and other inputs in alignment with Tech Comm and business quality processes.

Support approvals in PLM tools, facilitate translations requests, and support launch activities (electronic and hardcopy distribution activities, such as metadata information and print proofs).

Participate in project and team meetings, and collaborate with teams to create, analyze and finalize product manuals from planning through launch.

The ideal candidate will possess the following:

Required Knowledge and Experience: Requires practical knowledge and demonstrated competence within job area typically obtained through advanced education combined with experience. Requires a University Degree and minimum of 2 years of relevant experience, or advanced degree with 0 years of experience.

Top 3 skills sets required:

Strong collaboration and verbal/written communication skills.

Experience with various authoring tools (eg, InDesign, Framemaker, XML tools).

Experience in complex regulatory environments and robust quality processes.

Industry: Pharmaceuticals

Title: Technical Writer - CMC

Job ID:

Location: San Rafael, CA (Hybrid)

Duration: 06+ months contract (+Possibility of extension)

Details :

• Author CMC content, initiate reviews, lead comment adjudication/finalization to deliver a health authority submission-ready dossier(s).
• Excellent written and verbal communication skills.
• Ability to understand and interpret complex scientific information

Skills:

• Excellent written and verbal communication skills.
• Ability to understand and interpret complex scientific information

Job Summary:

CONTRACT POSITION - This position is responsible for bringing expertise in developing, reviewing, and managing technical documents to support pharmaceutical manufacturing operations.This role is essential for ensuring that all written materials comply with GMP, FDA, and DEA guidelines, with clear direction to address complex process and regulatory requirements to internal teams and external stakeholders. The ideal candidate will have experience with process mapping, root cause analysis, risk assessments, and quality system documentation. This role seeks to enhance cross-functional collaboration and knowledge transfer.

Essential Functions:

• Develop, revise, and maintain Standard Operating Procedures (SOPs), deviations, CAPAs, batch records, change controls, and protocols.
• Translate technical and scientific information into clear, compliant documentation.
• Collaborate with Quality Assurance, Manufacturing, Engineering, and other cross functional teams to drive problem solving and source material.
• Perform and maintain document control systems and revision tracking.
• Participates in investigations and deviations; assists in assigning root cause and the implementation of corrective and preventive actions (CAPA)
• Support CAPA, deviation, and change control documentation processes; perform line side problem solving for quick deviation documentation and resolution.
• Ensure all documentation aligns with GxP standards and internal quality systems.
• Provides communication within and between all shifts, departments, and levels of the company as needed.
• Assist with SOP training and provide guidance and training to staff members when there are revisions to SOPs.
• Utilize electronic document management system (Veeva), to manage approval workflow.
• Review technical content for clarity, accuracy, and compliance with company style guidelines.
• Develops and supports faster product release cycles through accurate and timely documentation.
• Proven experience producing documentation that passes audits with minimal findings.

Additional Responsibilities:

Perform other duties and responsibilities, as assigned.

Job Specifications:

• Bachelor’s degree (or equivalent) preferred in Life Sciences, Pharmacy, Chemistry or related field
• 2+ years’ experience as a Technical Writer in the GMP-regulated environment preferred.
• Experience in a cGMP Pharmaceutical manufacturing environment preferred.
• Strong understanding of pharmaceutical manufacturing processes, including ISO classification.
• Familiarity with FDA and DEA documentation requirements
• Knowledge of MS Word, MS Excel, and MS SharePoint. Proficiency in MS Excel preferred.
• Proficiency with document management systems (Veeva, Trackwise strongly preferred)
• Possesses excellent written/verbal communication and organizational skills.
• Conducts activities with professionalism and treats all associates with respect.
• Possesses a good understanding of manufacturing operations/systems and related processes.
• Requires the ability to work independently, with minimal supervision.
• Possesses good written and verbal communication skills.
• Ability to write SOPs (Standard Operating Procedures), incidents, deviations and change controls as needed.
• Comprehend and follow written procedures (batch records, operating procedures, protocols).
• Experience with Lean Principles and 6S preferred.

• Develop and maintain end-user documentation including user manuals , installation guides, troubleshooting instructions, and upgrade/downgrade procedures.
• Create and edit visual content  such as diagrams, flowcharts, illustrations, and product photos.
• Collaborate with cross-functional teams including engineering, QA, regulatory, clinical, and marketing to gather and verify content.
• Ensure documentation complies with industry standards  and regulatory requirements.
• Review and revise documents for clarity, accuracy, and consistency.
• Support documentation for Class II medical devices  and regulatory submissions across multiple countries.
• Participate in team meetings to align on documentation timelines and deliverables.

• Minimum 3 years of experience  in technical writing.
• Proficiency with authoring tools  such as:
  • Adobe FrameMaker
  • MadCap Flare
  • Adobe Illustrator
  • Adobe Creative Suite
• Experience working in a regulated industry  (medical devices, pharma, etc.).
• Bachelor’s degree in a relevant field.
• Ability to work independently and manage multiple projects under tight deadlines.

• Experience with SAP  or other ERP systems.
• Familiarity with version control systems  (GitHub, Perforce, etc.).
• Knowledge of electro-mechanical systems  and software applications.
• Experience with device labeling  and packaging content development.
  

• Medical, Prescription, Dental & Vision Benefits (for employees working 20+ hours per week)
• Health Savings Account (HSA) (for employees working 20+ hours per week)
• Life & Disability Insurance (for employees working 20+ hours per week)
• MetLife Voluntary Benefits
• Employee Assistance Program (EAP)
• 401K Retirement Savings Plan
• Direct Deposit & weekly epayroll
• Referral Bonus Programs
• Certification and training opportunities
  

Title : Sr. Technical Writer

Pay : $120K/year

Schedule : Onsite 5 days per week (NO flexibility on remote or hybrid)

Duration : Direct hire, Perm

Summary Statement:

Researches, creates, and edits operational, instructional, maintenance, and test procedural documents in accordance with internal guidelines by utilizing skills as a seasoned, experienced technical writer with a full understanding of industry standards/practices for technical documentation.

Essential Duties and Responsibilities :

• Use skills as a seasoned, experienced technical writer with a full understanding of industry standards/practices for technical documentation.
• Research, create, and edit operational, instructional, maintenance, and test procedural documents in accordance with internal guidelines as well as industry standards and best practices.
• Conduct interviews with and observe work performed by various users, technical staff, and production staff to gather data for documentation.
• Gather photographs and other useful media to enhance and provide visual clarification of documents.
• Research and translate technical information into manuals and/or documents for nontechnical and technical users.
• May audit processes and specifications.
• Produce work product that confirms to the company documentation and quality assurance standards.
• Utilize Microsoft Office products (MS Word, etc.) to prepare documents.
• Work on documentation of diverse scope.
• Coordinate reviews and approvals of draft documents with subject matter experts prior to finalizing/releasing documents.
• Interact with internal and external personnel at all levels.
• Performs housekeeping and clean-up tasks as required
• Performs all other duties requested, directed, or assigned

Education and Experience:

• Bachelor's degree (B.A.) from four-year college or university in a related discipline and 10-15 years of directly related experience and/or training; or equivalent combination of education and experience.
• 10 years “hands-on” experience with researching, creating, and editing manufacturing/test procedures, user manuals and other technical documentation.
• Extensive manufacturing background with technical products.
• ERP knowledge/experience; experience with IFS preferred

Job Knowledge, Skills and Abilities:

• Extensive knowledge of gathering information for and creating technical documentation for manufacturing and testing of technical products.
• Excellent information gathering skills.
• Extensive knowledge of reading, interpreting, and understanding technical drawings, diagrams, procedures, manuals and instructions.
• Exceptional ability in creating technical documentation for non-technical persons.
• Ability to analyze and comprehend information and inquiries furnished in written, verbal, or diagram form.
• Exceptional English grammar skills.
• Ability to communicate professionally with individuals at all levels of the organization.
• Strong mechanical aptitude.
• Good computer skills, especially MS Word, and ability to comprehend ERP.
• Self-starter with ability to work effectively with limited supervision.

Physical and Mental Demands:

• Ability to work in an office environment and a production environment.
• Ability to observe and collect data on manufacturing and test processes/methods.
• Ability to retain job related information and instructions.
• Ability to read and accurately interpret information.
• Ability to communicate effectively in English with customers, coworkers and managers.
• Ability to exchange accurate information.
• Ability to prepare clear and concise technical documents that are easily understood by non-technical persons.
• Specific vision abilities required for this position include close vision, distance vision, peripheral vision, depth perception, ability to distinguish colors, and ability to adjust focus.

Job Title: Technical Writing Specialist

Duration: 6 Weeks, 3 Days

Location: Irvine, CA 92606

Summary:

The main function of this technical writing specialist position is to develop, create, and update training materials supporting Client’s Manufacturing Execution System (MES) following Good Manufacturing Practices (GMP).

Key Responsibilities:

• Edit and create manufacturing system training materials (Standard Operating Procedures, basic visuals/ flow charts, storyboards for web based content, etc.) in collaboration with Engineers

• Create reusable templates where possible for training materials that will allow for rapid expansion of standardized content

• Assist in the maintenance of documentation in a standard format following established guidelines

• Partner with team members to facilitate clarification or explanation of reference materials and technical documentation

• Review documents for style, clarity, grammar, and punctuation

• Prepare materials for the change management process by gathering supporting documents and staging for formal review

• Identify and correct inconsistencies of thought, development, or organization and gain consensus with authors to make appropriate adjustment in documents and procedures

• Assist in interfacing with stakeholders (e.g, production employees, technicians, engineers, project teams, regulatory teams and management) to develop an understanding of the product, component, or device changes

• Other duties assigned by Leadership

Additional Skills:

• Proven expertise in Microsoft Office Suite including Word, Excel, Powerpoint, and Publisher; Microsoft Visio preferred

• Experience working with/ supporting major enterprise systems such as Enterprise Resource Planning (ERP), Manufacturing Execution System (MES), Product Lifecycle Management (PLM) style systems preferred

• Excellent editing and proofreading skills

• Excellent written and verbal communication skills in English including negotiating and relationship management skills

• Excellent problem-solving and critical thinking skills

• Full knowledge and understanding of policies, procedures and guidelines relevant in the development of technical documentation

• General knowledge of documentation (e.g, procedures, routers, process sheets, technical summaries, protocols, and test reports)

• Excellent technical writing skills

• General knowledge of product assembly procedures

• Ability to manage competing priorities in a fast paced environment

• Strict attention to detail

• Must be able to work in a team environment, including inter-departmental teams and key contact representing the organization on projects

Education and Experience:

• Bachelor's Degree or equivalent in related field

• 5-7 years of experience required