Technical Writer

A brief overview

The Technical Writer will prepare cGMP documentation, including protocols, reports, studies, Failure Mode and Effect Analyses (FMEAs), memos, forms, specifications, qualifications, change controls, deviations, Corrective and Preventative Actions (CAPA), Standard Operating Procedures (SOPs), and Master Batch Production Records (MBPRs). The Technical Writer is expected to be able to work independently and complete each type of document leveraging their experience and expertise. The Technical Writer works with customers to prepare documents, and in doing so, is expected to have a high degree of knowledge regarding the processes, procedures, and equipment that are used for manufacturing and analytical purposes. The Technical Writer is expected to ensure a high output of completed tasks that is commensurate with the position. The Technical Writer is expected to lead projects by creating timelines, organizing activities, and ensuring due dates are achieved. Project leadership should include communication with senior members of the Technical Writing group for resources to help manage the workload for these major projects.

What you will do

• Write and revise all types of documentation, such as protocols, reports, SOPs and associated forms, FMEAs, and MBPRs

• Review and complete all documentation following cGMP guidelines

• Ensure collaboration between all applicable departments, such as Production, Facilities, Materials Management, QA and QC

• Adhere to manufacturing schedules and timelines

• Propose technical improvements in documentation

• Participate in the validation of products and processes

• Schedule and participate in project meetings with subject material experts

• Communicate professionally and respectfully with customers if external review of documents is required

• Take leadership over major projects that include many different documents, due dates, and may require input from different departments and customers.

Qualifications

• Bachelor's Degree BS Degree in Chemistry or related field Required

• Minimum of 1 year of work experience as a chemist or scientist in a cGMP environment

• 1 year of technical writing experience

• Experience with cGMP manufacturing and documentation standards (preferred)

• Experience with peptide manufacturing and associated analytical methods (preferred)

• Experience with MasterControl or similar document control systems (preferred)

• Understanding of various in-process analytical methods (i.e., HPLC)

• Comfortable working around hazardous materials and chemicals

• Excellent written and oral communication skills

• Excellent computer skills, especially MS Office, document-sharing (i.e. SharePoint, ShareFile), online meetings (i.e., Skype)

• Ability to effectively organize, multitask, and work in a fast-paced, deadline driven work environment

• Ability to communicate in a proactive and solution-focused manner, including keeping management aware of potential issues

• Detail oriented with the ability to troubleshoot and resolve problems

• Ability to work independently and manage one’s time

• Ability to communicate effectively and function well in a team environment

• Ability to set up and facilitate meetings with key project stake holders

• Ability to follow up on document related tasks with other departments

Base Annual Salary Range: $56,640 to $106,920

Placement of new hires in these wage ranges is based on several factors including education, skill sets, experience, and training.

Total Rewards 

We offer all Team Members a total rewards package including competitive pay, annual performance bonus, a generous benefit package with comprehensive Medical/Dental/Vision coverage, 401(k) plan with employer contribution, and paid vacation, personal and sick days. 

Corporate Social Responsibility 

Bachem takes responsibility for future generations by a careful handling of resources and avoiding environmental risks. We continually improve our ecological performance and develop and implement new approaches for enhancing employees’ environmental awareness.  EcoVadis has awarded Bachem Gold Medal status in their assessment of Bachem. 

Bachem Americas is an Equal Opportunity Employer 

As an equal opportunity employer, we celebrate the diversity of our team and are committed to building an inclusive workplace where individuals are hired and advanced based on merit, skills, and qualifications. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, gender identity or expression, sexual orientation, national origin, genetics, disability, age, veteran status, or other legally protected status