Engineering Technical Writer (cGMP – Pharmaceutical)

Engineering Technical Writer cGMP – Pharmaceutical

 

AM Technical Solutions- Who Are We:

AM Technical Solutions (AM), founded in 1994, is a proven and licensed architecture, engineering, and construction firm bringing innovative solutions to the Biopharma industry to help in the fight to save lives.  Our knowledge and expertise in high-tech spaces combined with our culture-first mentality allows our team to deliver the entire scope of work for high-tech construction projects on schedule, on budget, and at the level of quality required by customers.  AM Life Science being an integrated part of AM Technical Solutions brings new energy and ideas to an ever-changing industry. Our team is comprised of motivated, intelligent, capable and qualified individuals who design, execute and manage projects and programs that implement risk-based approaches utilizing scientific data and justifications to align with the regulatory and industry standards. AM Life Science takes pride in our accuracy, efficiency, and integrity, which translates into cost and time savings for our Clients.

 

Job Title: 

Engineering Technical Writer (cGMP – Pharmaceutical)

Current Locations:

Boston, MA area

Position Description

AM Technical Solutions is looking for capable Technical Writers to work with a pharmaceutical client in the Boston, MA area. This individual will be expected to raise and author change controls, work orders, SOPs, user requirements, and turnover packages.

 

Direct Involvement Opportunities:

  • Responsible for writing and editing engineering documents including but not limited to change controls, work orders, turnover packages, and user requirements
  • Create new cGMP documents with assistance from within the department.
  • Manage document comments in order to answer and translate questions into the reviewed document to meet regulatory, internal, and external requirements.
  • Must be able to extract and coordinate information from multiple sources and consolidate material into technical documentation.
  • Maintain files and logs in a GMP state.

Qualifications, Skills, And Experience:

  • Bachelor’s degree in Engineering or Sciences is preferred.
  • 2-4 years of experience working within a GMP environment.
  • Demonstrated document editing and proofreading experience.
  • Must understand how CAPAs (corrective actions/preventative actions) and change controls must be incorporated into a document.
  • Strong written and oral communication skills
  • Highly organized with effective time management (ensuring completion of work tasks).
  • Strong attention to detail.
  • Ability to work well cross-functionally with various people and groups.