Manufacturing Engineer

Reposted 22 Days Ago
Be an Early Applicant
Frederick, CO, USA
In-Office
82K-129K Annually
Junior
Biotech
The Role
Support GMP manufacturing by transferring and scaling processes from development to production; create and review batch records, SOPs, and automated equipment methods; generate change controls, CAPAs, RAs, and EVs; troubleshoot process equipment; lead investigations of deviations; participate in project teams and technical transfers to ensure scalable, compliant manufacturing operations.
Summary Generated by Built In
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 [email protected] or contact +1-262-754-5030. For more information about equal employment opportunity protections, please visit www.agilent.com/en/accessibility.Travel Required: NoShift: DayDuration: No End DateJob Function: Manufacturing

Skills Required

  • Bachelor's degree in chemistry, biology, engineering or related life science field or equivalent experience
  • 2+ years relevant experience
  • Technical writing experience
  • Prior experience with large-scale pharmaceutical or biopharmaceutical manufacturing unit operations
  • Prior experience in a GMP manufacturing facility
  • Experience coordinating and participating in interdepartmental project teams
  • Knowledge of or experience with regulatory agencies and associated audits

Agilent Technologies Compensation & Benefits Highlights

The following summarizes recurring compensation and benefits themes identified from responses generated by popular LLMs to common candidate questions about Agilent Technologies and has not been reviewed or approved by Agilent Technologies.

  • Retirement Support The core U.S. package highlights a generous 401(k) match as a strength. Retirement programs are positioned as competitive within the company’s total rewards.
  • Equity Value & Accessibility An Employee Stock Purchase Plan at a discount provides accessible equity and augments total compensation. Ownership opportunities are presented as a notable advantage alongside retirement benefits.
  • Leave & Time Off Breadth Flexible Time Off, company holidays, a personal holiday, and paid volunteer time create a broad leave offering. Time off can accrue into multiple weeks in the first year, supporting flexibility.

Agilent Technologies Insights

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The Company
HQ: Santa Clara, CA
17,369 Employees
Year Founded: 1999

What We Do

Analytical scientists and clinical researchers worldwide rely on Agilent to help fulfill their most complex laboratory demands. Our instruments, software, services and consumables address the full range of scientific and laboratory management needs—so our customers can do what they do best: improve the world around us. Whether a laboratory is engaged in environmental testing, academic research, medical diagnostics, pharmaceuticals, petrochemicals or food testing, Agilent provides laboratory solutions to meet their full spectrum of needs. We work closely with customers to help address global trends that impact human health and the environment, and to anticipate future scientific needs. Our solutions improve the efficiency of the entire laboratory, from sample prep to data interpretation and management. Customers trust Agilent for solutions that enable insights...for a better world.

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