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Job Description

One of our large biotech companies is seeking a skilled and detail-oriented Technical Writer to join their dynamic team on a large project which is in the Pharmaceutical / Bio-technical industry. This role is crucial for supporting large capital projects by developing high-quality documentation that meets regulatory, company, and stakeholder standards. Ideal candidates will have a strong

background in technical writing within the pharmaceutical or biotech sectors and be adept at managing complex information and project deadlines. Responsibilities will include:

Create, revise, and maintain clear, concise technical documentation including but not limited

to User Requirements Specifications, Maintenance and Operational SOPs, Preventative

Maintenance (PM) Plans, Work Instructions, Bill Of Materials Lists.

Work closely with Project Leads, Site Engineering, Process Engineering, Automation

Engineering, Facilities / Maintenance and Metrology to gather the necessary information to

produce technical content within the documentation.

Ensure all documentation is compliant with industry standards, regulatory requirements, and

internal guidelines.

Participate in project meetings to understand project scope, milestones, and deliverables.

Coordinate the review, approval, and change management processes for all project-related

documents with cross functional departments.

As necessary develop templates and standards for future documentation to ensure

consistency and efficiency.

Provide input on document design and layout to enhance readability and user engagement.

Utilize document management systems to track and manage revisions and approvals.

Support technical data migration into appropriate electronic systems. (Engineering system,

CMMS, Validation system) as appropriate.

Adapt content for diverse audiences, ranging from technical experts to non-technical

stakeholders

We are a company committed to creating diverse and inclusive environments where people can bring their full, authentic selves to work every day. We are an equal opportunity/affirmative action employer that believes everyone matters. Qualified candidates will receive consideration for employment regardless of their race, color, ethnicity, religion, sex (including pregnancy), sexual orientation, gender identity and expression, marital status, national origin, ancestry, genetic factors, age, disability, protected veteran status, military or uniformed service member status, or any other status or characteristic protected by applicable laws, regulations, and ordinances. If you need assistance and/or a reasonable accommodation due to a disability during the application or recruiting process, please send a request to HR@insightglobal.com .

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Skills and Requirements

Bachelors degree in Technical field, English, Communications, or a related field.

Proven experience (8+ years) as a technical writer, preferably in the cGMP Pharmaceutical or

equivalent biotechnology industry.

Familiarity with regulatory compliance environments such as FDA, EMA, ICH, ISPE and USP

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We are a company committed to creating diverse and inclusive environments where people can bring their full, authentic selves to work every day. We are an equal employment opportunity/affirmative action employer that believes everyone matters. Qualified candidates will receive consideration for employment without regard to race, color, ethnicity, religion,sex (including pregnancy), sexual orientation, gender identity and expression, marital status, national origin, ancestry, genetic factors, age, disability, protected veteran status, military oruniformed service member status, or any other status or characteristic protected by applicable laws, regulations, andordinances. If you need assistance and/or a reasonable accommodation due to a disability during the application or the recruiting process, please send a request to HR@insightglobal.com.