Boulder, CO, US
21 days ago
Manager, Manufacturing Engineering
Job Description

The world's most revolutionary biopharma companies are partnering with Agilent Technologies to advance the next frontier of medicine. Agilent continues to invest in capacity and expansion of its Colorado operations. Join our team of professionals dedicated to the development and commercialization of nucleic acid therapeutics for life changing, lifesaving medicines.

The Manufacturing Engineer Manager position provides direction for a wide variety of technical duties to support manufacturing operations.

Oversees and supports the transfer and scale-up of new processes from Process Development into Manufacturing. Attends and participates in project team meetings to develop and execute project plans.

Interfaces with Process Development, Project Management, and Manufacturing to ensure small-scale development activities will scale to manufacturing equipment and systems.

Responsible for the review and approval of technology transfer documents from Process Development.

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

Coordinate the revision of standard operating procedures (SOPs) as required to support the transfer.

Supervises activities and projects of the MFG Engineers. Provides technical guidance on project execution and implementation.

Directs MFG Engineers during the scale-up existing processes in Manufacturing. Oversees, supports, and is responsible for writing and/or reviewing scale-up batch documentation, change controls and automated equipment methods. Coordinate the creation and/or revision of SOPs as required to support the scale-up.

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

Oversees, supports, and is responsible for communicating future development requirements or opportunities to the project team.

Assist manufacturing with problem solving and trouble-shooting process or process equipment including interfacing directly with external vendors and customers to clearly and concisely discuss and resolve the issue to meet production timelines, quality policies, and customer expectations.

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.

5+ years of experience in manufacturing engineering or process engineering, preferably in a regulated industry (e.g., pharmaceuticals, biotech, medical devices).

1+ years of experience leadership or supervisory experience managing engineering teams or cross-functional projects is helpful.

Prior experience in a GMP manufacturing facility preferred.

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Additional Details

This job has a full time weekly schedule. Applications for this job will be accepted until at least June 12, 2025 or until the job is no longer posted.

The full-time equivalent pay range for this position is $124,160.00 - $194,000.00/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 Affirmative Action employer. We value diversity 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 diversity in the workplace 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.

Travel Required: Occasional

Shift: Day

Duration: No End Date

Job Function: Manufacturing
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