Technical Writer 1

Technical Writer I

About the Role

We are seeking a detail-oriented Technical Writer I to support our Manufacturing Sciences team within a dynamic biologics manufacturing environment. In this role, you will investigate manufacturing events, analyze process and batch data, and author high-quality technical documentation that supports product quality, compliance, and continuous improvement initiatives. The ideal candidate combines strong scientific knowledge with exceptional technical writing skills and enjoys collaborating across manufacturing, quality, and process development teams. This position offers a unique opportunity to gain exposure to biologics manufacturing, root cause investigations, and quality systems while contributing directly to operational excellence.

Key Responsibilities

Technical Documentation & Investigations

- Author clear, accurate, and compliant investigation reports for manufacturing events and deviations.
- Review batch records, manufacturing documentation, and process data to identify trends and investigate issues.
- Collect, organize, and analyze data to support root cause investigations and corrective actions.
- Prepare technical summaries, reports, and quality documentation in accordance with company procedures and regulatory expectations.

Manufacturing & Quality Support

- Partner with Manufacturing, Quality, and Manufacturing Sciences teams to support site operations and resolve process-related issues.
- Evaluate manufacturing records for accuracy, completeness, and compliance requirements.
- Support continuous improvement initiatives through data-driven investigations and documentation.
- Participate in cross-functional discussions to identify process improvements and operational efficiencies.

Data Analysis & Process Understanding

- Analyze manufacturing performance data and operational trends.
- Apply scientific knowledge to assess manufacturing events involving biologics production processes.
- Support documentation efforts related to antibody manufacturing, protein purification, cell culture, and quality control activities.

Required Qualifications

- Bachelor's degree in Biology, Cell Biology, Biochemistry, Molecular Biology, Biotechnology, or a related life sciences discipline.
- Strong technical writing and scientific documentation skills.
- Scientific understanding of protein biology, cell biology, antibody manufacturing, or related biologics processes.
- Experience with one or more of the following: Biologics manufacturing
- Protein therapeutics
- Antibody products
- Cell culture
- Protein purification
- Process development
- Immunoassays

- Ability to independently conduct investigations and perform root cause analyses.
- Strong attention to detail with a focus on accuracy and documentation quality.
- Proficiency with Microsoft Office applications, particularly Excel, Word, and PowerPoint.
- Excellent written, verbal, and interpersonal communication skills.
- Ability to manage multiple priorities in a fast-paced manufacturing environment.

Preferred Qualifications

- Experience reviewing manufacturing batch records, deviations, investigations, or quality documentation.
- Knowledge of GMP-regulated manufacturing environments and quality systems.
- Familiarity with antibody purification, conjugation processes, and immunoassay quality control testing.
- Experience with Continuous Improvement, Lean Manufacturing, Practical Process Improvement (PPI), or similar methodologies.
- Exposure to manufacturing science, process development, or quality assurance functions.
- Strong project management and organizational skills.
- Experience collaborating across multiple departments to drive operational improvements.

Why Join Us?

- Gain hands-on experience in a world-class biologics manufacturing environment.
- Work alongside scientists, engineers, manufacturing professionals, and quality experts.
- Develop expertise in technical investigations, root cause analysis, and GMP documentation.
- Contribute to products that support healthcare and scientific advancement.
- Build a strong foundation for future career growth in Manufacturing Sciences, Quality, Process Development, or Technical Operations.

Work Environment

This position operates in a fast-paced manufacturing and scientific environment that supports biologics production. The role combines independent analytical work with collaborative cross-functional projects and requires frequent interaction with Manufacturing, Quality, and Technical Operations teams. Candidates should be comfortable working with manufacturing data, quality systems, electronic documentation platforms, and technical reporting tools. Job Type & Location This is a Contract position based out of Carlsbad, CA.
Pay and Benefits
The pay range for this position is $33.00 - $33.00/hr. Individual compensation offered for this position within this range will depend on many factors, including qualifications, skills, relevant experience, job knowledge, geographic location, internal equity, and other pertinent job-related factors. Eligibility requirements apply to some benefits and may depend on your job
classification and length of employment. Benefits are subject to change and may be
subject to specific elections, plan, or program terms. If eligible, the benefits
available for this temporary role may include the following:

Medical, dental & vision
Critical Illness, Accident, and Hospital
401(k) Retirement Plan Pre-tax and Roth post-tax contributions available
Life Insurance (Voluntary Life & AD&D for the employee and dependents)
Short and long-term disability
Health Spending Account (HSA)
Transportation benefits
Employee Assistance Program
Time Off/Leave (PTO, Vacation or Sick Leave)
Workplace Type
This is a fully onsite position in Carlsbad,CA.
Application Deadline
This position is anticipated to close on Sep 30, 2026. About Actalent

Actalent is a global leader in engineering and sciences services and talent solutions. We help visionary companies advance their engineering and science initiatives through access to specialized experts who drive scale, innovation and speed to market. With a network of almost 20,000 consultants and 5,000 clients across the U.S., Canada, Asia and Europe, Actalent serves many of the Fortune 500. We are proud to be an Engineering News-Record (ENR) Top 500 Design Firm for our engineering design services and a ClearlyRated Best of Staffing® winner for both client and talent service.

The company is an equal opportunity employer and will consider all applications without
regard to race, sex, age, color, religion, national origin, veteran status, disability,
sexual orientation, gender identity, genetic information or any characteristic protected
by law.

If you would like to request a reasonable accommodation, such as the modification or
adjustment of the job application process or interviewing process due to a disability,
please email [email protected] for other accommodation options.

San Francisco Fair Chance Ordinance:
Pursuant to the San Francisco Fair Chance Ordinance, for all positions located in the
city and county of San Francisco, we will consider for employment qualified applicants
with arrest and conviction records.

Massachusetts Lie Detector:
It is unlawful in Massachusetts to require or administer a lie detector test as a
condition of employment or continued employment. An employer who violates this law
shall be subject to criminal penalties and civil liability.

Use of Artificial Intelligence (AI):
We may use Artificial Intelligence (AI) to support parts of our hiring process,
including sourcing, screening, and evaluating candidates. AI helps assess applications
and qualifications, but final decisions are made by our hiring team. By applying, you
acknowledge and agree that your application may be reviewed using AI tools.