Manufacturing Engineer

US-CO-Frederick$82,480 - $128,8752+ years

Job Description

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.

Qualifications

Bachelor's degree in chemistry, biology, engineering or related life science field; or an equivalent combination of education and related experience.
2+ 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.

Additional Details

This job has a full time weekly schedule. Applications for this job will be accepted until at least June 15, 2026 or until the job is no longer posted.

The full-time equivalent pay range for this position is $82,480.00 - $128,875.00/yr plus eligibility for bonus, stock and benefits. Our pay ranges are determined by role, level, and location. Within the range, individual pay is determined by work location and additional factors, including job-related skills, experience, and relevant education or training. During the hiring process, a recruiter can share more about the specific pay range for a preferred location. Pay and benefit information by country are available at: https://careers.agilent.com/locations

Agilent Technologies, Inc. is an Equal Employment Opportunity and merit-based employer that values individuals of all backgrounds at all levels. All individuals, regardless of personal characteristics, are encouraged to apply. All qualified applicants will receive consideration for employment without regard to sex, pregnancy, race, religion or religious creed, color, gender, gender identity, gender expression, national origin, ancestry, physical or mental disability, medical condition, genetic information, marital status, registered domestic partner status, age, sexual orientation, military or veteran status, protected veteran status, or any other basis protected by federal, state, local law, ordinance, or regulation and will not be discriminated against on these bases. Agilent Technologies, Inc., is committed to creating and maintaining an inclusive in the workplace where everyone is welcome, and strives to support candidates with disabilities. If you have a disability and need assistance with any part of the application or interview process or have questions about workplace accessibility, please email job_posting@agilent.com or contact +1-262-754-5030. For more information about equal employment opportunity protections, please visit www.agilent.com/en/accessibility.