Technical Writer

Actalent; Carlsbad (CA); On-site; USD 38,000 - 53,000; Full time

Benefits offered by this job

Medical, dental & vision

401(k) Retirement Plan

Life Insurance

Short and long-term disability

Health Spending Account (HSA)

Transportation benefits

Employee Assistance Program

PTO / Vacation

Job summary

Actalent is seeking a detail-oriented Technical Writer I to support manufacturing operations by investigating and documenting root cause analyses, deviations, and investigations in a GMP-regulated environment. You will review batch and production records and work with cross-functional teams to create clear procedures and documentation.

The role emphasizes strong communication, data analysis, and adherence to quality standards in a fast-paced setting within Carlsbad, CA.

Qualifications

• Bachelor's Degree in Science, Engineering, Biology, Chemistry, Biochemistry, Biotechnology, or related STEM field.
• Experience reviewing manufacturing batch records, GMP documentation, or quality records.
• Knowledge of GMP-regulated manufacturing environments.
• Experience performing investigations and root cause analysis.
• Familiarity with Continuous Improvement, Lean, PPI, Six Sigma, or equivalent methodologies.
• Strong Microsoft Office skills, especially Excel.
• Excellent written, verbal, and technical communication skills.
• Strong organizational, project management, and time management abilities.
• Ability to work effectively in a fast-paced, collaborative environment.

Responsibilities

• Author and maintain investigation reports, deviation documentation, and root cause analyses in compliance with quality and regulatory standards.
• Review manufacturing batch records, production records, and process documentation to identify trends, discrepancies, and opportunities for improvement.
• Analyze historical manufacturing data and documentation to support investigations and operational decisions.
• Partner with manufacturing, quality, and technical teams to develop clear and effective procedures, work instructions, and documentation.
• Utilize ERP, Quality Management Systems (QMS), and Document Management Systems (DMS) to support investigations and documentation activities.
• Ensure timely completion of investigations while maintaining accuracy, compliance, and documentation quality.
• Support process improvement initiatives and continuous improvement projects.

Skills

GMP documentation

Root cause analysis

Cross-functional collaboration

Technical communication

Excel proficiency

Documentation standards

Education

Bachelor's degree in Science/Engineering/related STEM

Tools

ERP

QMS

DMS

Job description

Technical Writer I - Manufacturing Sciences

About the Role

We are seeking a detail-oriented Technical Writer I to join our Manufacturing Sciences team. In this role, you will support manufacturing operations by conducting investigations, performing root cause analysis, reviewing production documentation, and authoring compliant reports in a regulated manufacturing environment. This position is ideal for candidates with a Science or Engineering degree and experience working with GMP documentation, manufacturing records, quality systems, and cross-functional teams.

Key Responsibilities

• Author and maintain investigation reports, deviation documentation, and root cause analyses in compliance with quality and regulatory standards.
• Review manufacturing batch records, production records, and process documentation to identify trends, discrepancies, and opportunities for improvement.
• Analyze historical manufacturing data and documentation to support investigations and operational decisions.
• Partner with manufacturing, quality, and technical teams to develop clear and effective procedures, work instructions, and documentation.
• Utilize ERP, Quality Management Systems (QMS), and Document Management Systems (DMS) to support investigations and documentation activities.
• Ensure timely completion of investigations while maintaining accuracy, compliance, and documentation quality.
• Support process improvement initiatives and continuous improvement projects.

Required Qualifications

• Bachelor's Degree in Science, Engineering, Biology, Chemistry, Biochemistry, Biotechnology, or related STEM field.
• Experience reviewing manufacturing batch records, GMP documentation, or quality records.
• Knowledge of GMP-regulated manufacturing environments.
• Experience performing investigations and root cause analysis.
• Familiarity with Continuous Improvement, Lean, PPI, Six Sigma, or equivalent methodologies.
• Strong Microsoft Office skills, especially Excel.
• Excellent written, verbal, and technical communication skills.
• Strong organizational, project management, and time management abilities.
• Ability to work effectively in a fast-paced, collaborative environment.

Preferred Qualifications

• Experience with ERP systems, QMS, and electronic document management systems.
• Understanding of biopharmaceutical or diagnostic manufacturing processes.
• Knowledge of:
• Antibody Purification
• Conjugation Processes
• Immunoassay Quality Control (QC) Assays
• Experience supporting manufacturing investigations and quality-related initiatives.

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 21, 2026.

About Actalent

Actalent is a global leader in engineering and sciences services and talent solutions. We help visionary companies advance our 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.