Technical Writer 1

Actalent; Carlsbad (CA); In loco; USD 39.000 - 52.000; Tempo pieno

Descrizione del lavoro

Actalent is seeking a Technical Writer I to support GMP manufacturing operations by investigating events, analyzing data, and authoring investigation reports.

The role requires a biology/biochem/biotech background, strong writing skills, and the ability to work with Manufacturing, Quality, and Process Sciences teams in a regulated environment. Contract position based in Carlsbad, CA.

Competenze

• Bachelor’s degree in biology or related science.
• Strong foundation in biology, cell biology, or biologics manufacturing.
• Experience reviewing technical, manufacturing, or quality documents.
• Ability to analyze data and identify trends.

Mansioni

• Review batch records, production documents, and quality records for accuracy and compliance.
• Investigate manufacturing events by data gathering and analysis.
• Author clear, compliant investigation reports to support GMP operations.
• Perform root cause analysis to identify process gaps and improvements.
• Analyze data to identify trends, assess risk, and aid decision-making.
• Collaborate with Manufacturing, Quality Assurance, and Process Sciences teams.
• Support implementation of process improvements and continuous improvement initiatives.
• Interpret data related to biologics, cell culture, and purification processes.
• Manage multiple investigations and documentation tasks to meet quality standards and timelines.
• Present findings and recommendations in reports and team discussions.

Conoscenze

Data analysis

Technical writing

Cross-functional collaboration

Attention to detail

Independent work

Project prioritization

Microsoft Excel

Formazione

Bachelor's degree in Biology/Biochemistry/Cell Biology/Molecular Biology/Biotechnology

Strumenti

Microsoft Office

Descrizione del lavoro

Technical Writer IOverview

Join a dynamic Manufacturing Sciences team supporting the production of life-changing biologics and antibody-based products. As a Technical Writer I, you will play a critical role in investigating manufacturing events, analyzing production data, and authoring high-quality investigation reports that directly support GMP manufacturing operations.

This position is ideal for a scientifically minded professional with a background in biology, biotechnology, biochemistry, or a related field who enjoys problem-solving, technical writing, data analysis, and cross-functional collaboration. You'll work closely with Manufacturing, Quality, and Process Sciences teams to identify root causes, drive corrective actions, and support continuous improvement initiatives in a highly regulated environment.

Key Responsibilities

• Review manufacturing batch records, production documentation, and quality records for accuracy, completeness, and compliance.

• Investigate manufacturing events and deviations by gathering data, conducting analysis, and collaborating with cross-functional stakeholders.

• Author clear, concise, and technically accurate investigation reports that support quality and manufacturing operations.

• Perform root cause analyses to identify process gaps, contributing factors, and opportunities for improvement.

• Analyze manufacturing and process data to identify trends, assess risk, and support decision-making.

• Collaborate with Manufacturing, Quality Assurance, and other functional teams to resolve quality-related issues.

• Support implementation of process improvements and continuous improvement initiatives.

• Interpret data and records related to biologics manufacturing, antibody production, cell culture, protein purification, and related processes.

• Manage multiple investigations and documentation activities while meeting quality standards and timelines.

• Present findings and recommendations through written reports and team discussions.

Required Qualifications

• Bachelor's degree in Biology, Biochemistry, Cell Biology, Molecular Biology, Biotechnology, or a related scientific discipline.

• Strong scientific foundation in cell biology, protein biology, or biologics manufacturing.

• Experience reviewing technical, manufacturing, laboratory, or quality documentation.

• Ability to analyze data, identify trends, and support investigative activities.

• Strong technical writing skills with the ability to create clear and compliant documentation.

• Excellent attention to detail and organizational skills.

• Proficiency with Microsoft Office, including Excel.

• Strong communication and collaboration skills.

• Ability to work independently while managing multiple priorities in a fast-paced environment.

Preferred Qualifications

• Experience in biologics, cell culture, protein therapeutics, antibody production, protein purification, immunoassays, or related scientific fields.

• Exposure to GMP-regulated manufacturing, quality systems, or pharmaceutical/biotechnology environments.

• Experience writing investigations, deviations, CAPAs, technical reports, or regulated documentation.

• Knowledge of antibody purification, conjugation processes, and immunoassay testing.

• Familiarity with Lean Manufacturing, Continuous Improvement, PPI, or similar methodologies.

• Experience working on cross-functional projects within manufacturing, quality, or process development organizations.

Ideal Candidate

We're looking for someone who is:

• Analytical and naturally curious, with a passion for investigating and solving complex problems.

• Detail-oriented and committed to producing high-quality, accurate documentation.

• Comfortable interpreting scientific data and translating findings into clear written reports.

• Collaborative and effective when working across multiple teams and stakeholders.

• Adaptable, organized, and able to thrive in a fast-paced manufacturing environment.

• Motivated to contribute to continuous improvement efforts that enhance quality, compliance, and operational excellence.

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 Oct 14, 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 [e-mail] 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.