GxP Associates is a fast-growing talent and workforce solutions company supporting pharmaceutical, biotechnology, and medical device organizations with highly skilled engineering, quality, validation, regulatory, and IT professionals.

We partner with clients and suppliers to deliver qualified talent for GxP, CSV, quality, regulatory, manufacturing, and technical operations roles, helping organizations maintain compliance, strengthen operations, and successfully execute critical projects in regulated environments.

Driven by integrity, speed, and industry expertise, we bridge the gap between exceptional talent and innovative life sciences companies. Our flexible delivery models and strong candidate network enable us to provide reliable staffing and business solutions that create long-term value for clients, consultants, and partners.

At GxP Associates, we don’t just fill positions—we build partnerships that drive growth, compliance, and success across the life sciences industry.

Industry: Professional Services
Company Size: 11-50 employees

GxP Associates

Savvy Admin PROD

**Job Summary **

We are seeking a detail-oriented Technical Writer with **0–3 years of experience ** to create, maintain, and improve high-quality documentation for our products, systems, and processes. The ideal candidate will collaborate with cross-functional teams including Engineering, Quality, Product Management, and Regulatory to deliver clear, accurate, and user-friendly documentation. This role is well-suited for early-career professionals looking to build expertise in technical writing within fast-paced and regulated environments.

**Key Responsibilities **

- Develop, edit, and maintain technical documentation including user manuals, SOPs, API documentation, and knowledge base articles

- Translate complex technical concepts into clear, concise, and easy-to-understand content

- Work closely with SMEs (Subject Matter Experts), developers, QA, and product teams to gather requirements and technical details

- Create and manage documentation for software systems, tools, and workflows

- Ensure all documentation complies with company standards, regulatory requirements, and industry best practices

- Maintain version control and document lifecycle management in tools like SharePoint, Confluence, or document management systems

- Support audit readiness by ensuring documentation accuracy and traceability

- Continuously improve documentation processes and templates

- Conduct document reviews and updates based on product releases and feedback

**Required Qualifications **

- Bachelor’s degree in Engineering, Computer Science, Life Sciences, or a related field

- 0–3 years of experience as a Technical Writer in IT, software, or regulated industries (medical device, pharma, etc.)

- Strong writing, editing, and proofreading skills

- Experience with documentation tools such as MS Word, Confluence, MadCap Flare, or Adobe FrameMaker

- Familiarity with version control systems (e.g., Git) and documentation workflows

- Ability to understand technical concepts and communicate them effectively

- Experience working in Agile or Scrum environments

**Preferred Qualifications **

- Experience in regulated environments (ISO 13485, FDA, GxP)

- Knowledge of QMS documentation (SOPs, CAPA, validation documents)

- Exposure to API documentation tools (Swagger, Postman)

- Basic understanding of HTML/CSS or Markdown

- Experience with eQMS or PLM systems

Technical Writer

**Position Summary **

We are seeking a detail-oriented Equipment Validation Engineer with **0–3 years of experience ** to support equipment qualification and validation activities within a **cGMP-regulated pharmaceutical/biotech manufacturing environment in New Jersey **. This role offers hands-on exposure to **IQ/OQ/PQ execution, commissioning & qualification (C&Q), and regulatory compliance (FDA, cGMP) **, making it an excellent opportunity for early-career professionals to build a strong foundation in validation and quality systems.

**Key Responsibilities **

- Execute and support **Installation Qualification (IQ), Operational Qualification (OQ), and Performance Qualification (PQ) ** protocols for manufacturing equipment.

- Assist in authoring, reviewing, and executing **validation protocols, reports, and technical documentation **.

- Participate in **commissioning and qualification (C&Q) ** activities for new equipment and system modifications.

- Perform **test execution, data analysis, and documentation ** in compliance with cGMP and GDP standards.

- Collaborate cross-functionally with **Engineering, Manufacturing, and Quality Assurance (QA) ** teams.

- Support **deviation investigations, change controls, and CAPA activities ** related to validation.

- Assist in **risk assessments (FMEA, impact analysis) ** to support validation planning.

- Ensure compliance with **data integrity standards (ALCOA+) **.

- Support **calibration, preventive maintenance, and equipment lifecycle documentation **.

- Maintain validation documentation in an **audit-ready state ** for regulatory inspections.

**Basic Qualifications **

- Bachelor’s degree in **Mechanical, Chemical, Biomedical, or related Engineering discipline **.

- **0–3 years of experience ** in validation, engineering, or quality within regulated environments (internships/projects acceptable).

- Working knowledge of **cGMP, FDA regulations, and validation lifecycle concepts **.

- Familiarity with **IQ/OQ/PQ documentation and execution **.

- Strong technical writing and documentation skills.

- Effective communication and collaboration skills.

**Preferred Qualifications **

- Exposure to **pharmaceutical, biotechnology, or medical device manufacturing **.

- Basic understanding of **critical utilities (HVAC, compressed air, WFI/PW systems) **.

- Experience or familiarity with **TrackWise, SAP, Veeva, or similar quality systems **.

Equipment Validation Engineer

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