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1+ months

Facility Engineer Technical Writer - Pearland, TX

Kelly Services
Pearland, TX 77588
**Job Description Summary:**


The Technical Writer will act as a point of contact initiating quality records and collaborating with those required for support and needing to provide input with regards to cGMP procedures and investigations.


+ Write and revise documents, including but not limited to Facilities and Engineering maintenance and calibration procedures.

+ Serve as lead in initiating document revisions and quality records.

+ Implement EPS (Error Prevention System) to Facilities and Engineering standard operating procedures.

+ Collaborate with other departments to develop user-friendly procedures.

+ Offer suggestions on improving document format to make documents more usable to the target audience.

+ Conduct training on new and revised SOPs and as required due to manufacturing document format changes.

+ Provide assistance and advice to internal customers on the use of the Electronic Document Management System.

+ Other document projects as assigned by the department manager.

+ Maintenance of quality systems and cGMP compliance for the business by ensuring that all team members comply with processes, procedures and instructions for all activities in which the team participates.

+ Perform other duties as assigned.


**EDUCATION:**


Engineering Degree preferred


**WORK EXPERIENCE:**


+ Quality Engineering, Engineering Technical Writer. Biotech/biopharma laboratory and/or manufacturing experience - 5-10 years

+ GMP Compliance - 5-10 years


**RESPONSIBILITIES:**


**Quality:** Technical Writer will support Facilities and Engineering in improving Quality of standard operating procedures and Quality investigations.


**Safety:** Technical Writer will support Facilities and Engineering ensuring that standard operating procedures are written with safety considerations for operators and equipment.


+ Technical writing including engineering, facilities and equipment documentation, i.e. standard operating procedures, deviation investigation, user requirement specification, and new equipment assessment.

+ GMP compliance knowledge; direct knowledge of relevant documentation requirements for cooperative manufacturing

+ Part 11 compliance knowledge

+ Computer software skills including Microsoft Office, database and spreadsheet creation and maintenance, filing, organization, record keeping and planning skills, multiple projects, time management

+ Excellent Written and oral communication skills; listening skills; independent and self-directed

+ Must know and follow job safety procedures, attend required health and safety training, proactively promote safety at work, and promptly report actual and potential accidents and injuries.

+ Must comply with safety policies of the company and site.


**Quality Responsibility:** Adherence to cGMPs procedures is required at all times. All personnel own the quality of what they deliver and are responsible for notifying responsible management in a timely manner of regulatory inspections, serious GMP deficiencies, process deviations, product defects and related actions.


**Why Kelly** **** **?**


Your engineering skills are in demand, but how do you find the right fit? Easy. With Kelly Engineering, our experts connect you with leading organizations where you can learn and grow, collaborate on innovative projects, and keep your skills sharp with top technology. Whether you prefer the variety and flexibility of short-term projects, or are looking for something more long-term, were here every step of the way to find your dream engineering job.


**About Kelly** ****


At Kelly, were always thinking about whats next and advising job seekers on new ways of working to reach their full potential. In fact, were a leading advocate for temporary/nontraditional workstyles, because we believe they allow flexibility and tremendous growth opportunities that enable a better way to work and live (plus, did we mention we provide a ton of benefits ?). Connecting great people with great companies is what we do best, and our employment opportunities span a wide variety of workstyles, skill levels, and industries around the world.


Kelly is an equal opportunity employer committed to employing a diverse workforce and providing accommodations for people with disabilities in all parts of the hiring process as required under its Employment Accommodation Policy. Kelly will work with applicants to meet accommodation needs that are made known to Kelly in advance.
Posted: 2021-02-26 Expires: 2021-04-26

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Facility Engineer Technical Writer - Pearland, TX

Kelly Services
Pearland, TX 77588

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