Process Engineer

Job Description

Want to take your knowledge and experience further? Ready to provide technical leadership and make key decisions? This is your opportunity - not only to join a committed, professional, and forward-thinking team but also to lead in the design and implementation of complex manufacturing processes and transform broad concepts into structured results-focused projects.

Join a growing team with this exciting new opportunity for an advanced level Process Engineer at our Frederick, Colorado GMP facility. Work in our dynamic, fast-paced, API-Biopharma manufacturing environment with the ability to contribute to the growing industry of oligonucleotide (DNA-RNA) based therapeutics.

Responsibilities may include but are not limited to:

• Support the Manufacturing group with day-to-day troubleshooting and maintenance activities, identification of process improvement and optimization opportunities, review of SOPs and MBRs.

• Responsible for small to large sized capital projects throughout all phases of the project lifecycle, including the development of user requirement specifications, process design, equipment and instrumentation specification/selection, equipment procurement, installation, commissioning, qualification, and turn-over to manufacturing.

• Responsible for project management aspects, including project schedule, budget, and coordination of multi-disciplinary teams.

• Support Chemical Development and Manufacturing Tech Services groups with activities such as technical transfer and scale-up of processes into manufacturing.

• Support EHS activities including PHA, PSSR, and PSM compliance.

• Support Validation activities including review of Factory Acceptance Test and Site Acceptance Test (FAT/SAT) protocols and participating in FAT/SAT execution, review of installation, operational, and performance qualification (IQ/OQ/PQ) protocols, participating in IOPQ execution, and review of final reports.

• Support Quality Assurance activities including writing, review, and/or resolution of Change Controls (CC/CSC), Corrective and Preventive Actions (CAPAs), and audit responses.

• Perform job functions and responsibilities independently and with limited direction.

Qualifications

• Bachelor's or Master's Degree in Chemical Engineering or equivalent education / experience. 

• 4+ years of combined experience in pharma/biopharma and fine chemicals industry to include experience with P&IDs, facility layouts, mass and energy balances, solvent handling, equipment sizing calculations, user requirement specifications (URSs), standard operating procedures (SOPs), and process troubleshooting.

Desired qualifications:

• 3+ years of experience managing small to large-sized projects through all phases, including design, design review, process hazard analysis, equipment procurement, installation, commissioning, and qualification is desirable.

• Familiarity with current ASME BPE hygienic piping and equipment design standards, electrical standards such as National Fire Protection Association / National Electrical Code (NFPA 70 / NEC), and International Fire and Building Code.

• Experience with design and programming of industrial control systems, including SCADA, PLCs, and BAS.

• Experience with validation documentation, including installation, operational, and performance qualification (IQ/OQ/PQ) protocols.

• Ability to use AutoCAD or Visio.

• Engineering, communication, and organizational skills to support the safe, efficient, and compliant production of API within a fast-paced, dynamic, contract manufacturing facility.

• Self-motivated, hands-on problem solver with the ability to work within multi-discipline teams, including process development, manufacturing, validation, quality assurance, safety, and project management personnel.

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Additional Details

This job has a full time weekly schedule. Applications for this job will be accepted until at least November 10, 2025 or until the job is no longer posted.

The full-time equivalent pay range for this position is $103,200.00 - $161,250.00/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: OccasionalShift: DayDuration: No End DateJob Function: Manufacturing