Technical Writer

Job Title : Manufacturing Engineer

Location - Frederick Colorado

Duration: 6- 18 months

Pay range : $35-37/hr on W2 without Benefits.

Job Description:
By delivering high-quality, innovative products to customers when and where they need them, Manufacturing Team supports our company's mission to inspire scientists and researchers to make discoveries that advance the quality of life. Join our fast-growing, dynamic organization and be part of this exciting work.

The Manufacturing Engineer position performs a wide variety of technical duties to support GMP manufacturing operations.

Transfer and scale-up of new processes from Chemical Development into Manufacturing.

Scale-up of existing processes in Manufacturing.

Responsible for writing and/or reviewing new process documentation (master batch records or data capture forms) and automated equipment methods.

Responsible for revising and/or reviewing existing batch documentation and automated equipment methods for process improvements.

Generate and/or review change control records (CC), risk assessments (RA), corrective and preventive actions (CAPA), and effectiveness verification records (EV) to maintain compliance with Current Good Manufacturing Practices (cGMP)

Assist manufacturing with real-time problem solving and troubleshooting for processes and/or process equipment.

Attend and participate in project team meetings to develop and execute project plans. Interface with Chemical Development and Manufacturing to ensure small-scale development activities will scale to manufacturing equipment and systems.

Responsible for the review and approval of technical transfer documents from Chemical Development to ensure compatibility with process equipment.

Coordinate the revision of standard operating procedures (SOP) as required to support new process implementation and/or scale-up.

Responsible for the generation and/or review of batch summaries for all batches produced in the manufacturing facilities.

Responsible for communicating future development requirements or opportunities to the project team.

Actively lead or participate in the investigation of major process deviations including providing technical assistance to Quality Assurance (QA) on the final product impact assessment and identification of root cause as necessary.

Job Posting Qualifications Job Posting Qualifications

Bachelor's degree in chemistry, biology, engineering or related life science field; or an equivalent combination of education and related experience

4 years relevant experience required

Technical writing experience required

Prior experience with large-scale pharmaceutical or biopharmaceutical manufacturing unit operations preferred

Prior experience in a GMP manufacturing facility preferred

Experience coordinating and participating in interdepartmental project teams preferred

Knowledge of or experience with regulatory agencies and associated audits preferred

Knowledge of or experience with process validation preferred

Dexian is a leading provider of staffing, IT, and workforce solutions with over 12,000 employees and 70 locations worldwide. As one of the largest IT staffing companies and the 2nd largest minority-owned staffing company in the U.S., Dexian was formed in 2023 through the merger of DISYS and Signature Consultants. Combining the best elements of its core companies, Dexian's platform connects talent, technology, and organizations to produce game-changing results that help everyone achieve their ambitions and goals.

Dexian's brands include Dexian DISYS, Dexian Signature Consultants, Dexian Government Solutions, Dexian Talent Development and Dexian IT Solutions. Visit https://dexian.com/ to learn more.

Dexian is an Equal Opportunity Employer that recruits and hires qualified candidates without regard to race, religion, sex, sexual orientation, gender identity, age, national origin, ancestry, citizenship, disability, or veteran status.