Technical Writer

Job Title: Technical Writer (Pharmaceutical GMP Environment)

Job Description

This Technical Writer role supports documentation activities in a regulated pharmaceutical manufacturing environment. You will author, review, and revise a wide range of GMP documents and quality system records while partnering closely with Manufacturing, Engineering, Validation, and Quality teams. The position is based in Sacramento, CA, operates primarily on a MondayFriday day shift schedule, and is offered as a 6month contract with potential for extension or conversion. The role is ideal for a self-starter who can quickly understand complex processes, identify documentation gaps, and independently produce clear, compliant, and technically accurate documentation with minimal supervision in a fast-paced, growing organization.

Responsibilities

• Author, edit, and maintain GMP documentation, including batch records, standard operating procedures (SOPs), deviations, investigations, corrective and preventive actions (CAPAs), change controls, qualification protocols, performance qualification (PQ) protocols and reports, validation documentation, and technical and summary reports.

• Partner with Manufacturing, Engineering, Validation, and Quality teams to gather technical information and translate it into clear, concise, and compliant documentation.

• Review existing documentation and workflows to identify gaps, inconsistencies, and opportunities for process and documentation improvement.

• Ensure all documentation complies with FDA regulations, current Good Manufacturing Practices (cGMP), and internal quality and compliance standards.

• Support the execution and documentation of quality system activities within electronic quality management systems.

• Coordinate document revisions and updates based on process improvements, equipment changes, and evolving regulatory expectations.

• Maintain document control, traceability, and compliance throughout the entire document lifecycle.

• Participate in cross-functional projects and support business initiatives related to process improvements, validation activities, and organizational growth.

• Quickly assess existing processes in the GMP environment, identify documentation gaps, and develop compliant documentation with minimal training or oversight.

• Manage multiple documentation projects simultaneously while maintaining a high level of quality, accuracy, and regulatory compliance.

Essential Skills

• Bachelors degree in a scientific, engineering, or related discipline preferred.

• 3+ years of technical writing experience in a regulated industry.

• Experience authoring GMP documentation in a pharmaceutical, biotechnology, medical device, or other FDA-regulated environment.

• Strong experience writing SOPs, batch records, deviations, investigations, CAPAs, change controls, and validation and qualification documentation.

• Working knowledge of FDA regulations and current Good Manufacturing Practices (cGMP).

• Excellent written communication skills and demonstrated ability to produce clear, structured technical documentation.

• Ability to independently gather information from subject matter experts, manage priorities, and execute projects with limited direction.

• Strong attention to detail and ability to identify documentation gaps, inconsistencies, and compliance risks.

• Ability to operate effectively in a fast-paced environment and manage multiple concurrent projects.

• Target experience level of approximately 37 years in relevant technical writing and regulated environments.

Additional Skills & Qualifications

• Pharmaceutical manufacturing experience strongly preferred.

• Experience supporting validation and qualification activities, including protocols and reports.

• Familiarity with electronic quality management systems (QMS).

• Experience in company integration, process improvement, or documentation remediation projects is a plus.

• Demonstrated ability to quickly understand complex manufacturing and validation processes in a GMP environment.

• Organized, proactive, and comfortable working with cross-functional teams.

• High level of independence, ownership, and execution in managing documentation responsibilities.

Work Environment

This role is based in Sacramento, CA, within a regulated pharmaceutical GMP manufacturing environment that emphasizes quality, compliance, and continuous improvement. You will work closely with Manufacturing, Engineering, Validation, and Quality teams and collaborate across functions on process improvement and validation initiatives. The schedule is primarily MondayFriday during the day shift, but flexibility is required to support occasional swing, graveyard, evening, or weekend work when manufacturing, validation, or quality activities demand it. The position is structured as a 6month contract with potential for extension or conversion, offering the opportunity to contribute to a growing organization with many exciting developments underway. The environment is fast-paced, detail-oriented, and highly regulated, with a strong focus on accurate documentation, adherence to FDA and cGMP requirements, and robust quality systems supported by electronic QMS tools.

Job Type & Location

This is a Contract position based out of Sacramento, CA.

Pay and Benefits

The pay range for this position is $40.00 - $55.00/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 Sacramento,CA.

Application Deadline

This position is anticipated to close on Oct 9, 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.