Project Engineer
Project Engineer
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$ 97920 - 153000
1 Vacancy
Job Description
Job Description
Agilent inspires and supports discoveries that advance the quality of life. We provide life science diagnostic and applied market laboratories worldwide with instruments services consumables applications and expertise. Agilent enables customers to gain the answers and insights they seek ---- so they can do what they do best: improve the world around us. Information about Agilent is available at .
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 a Process/Project 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. This role will support an exciting project that is expected to significantly grow and expand the Oligo-manufacturing capability of our Colorado sites.
Responsibilities may include but are not limited to:
Support design construction commissioning and qualification activities for newly created capital projects from concept design through validation of new processes. Work hand in hand with Design Firm Equipment Suppliers and all other cross-functional teams.
Responsible for supporting a variety of 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 turnover to manufacturing.
Primary immediate responsibility will be supporting the existing large-scale capital project. Brownfield construction 80% completed. The candidate will function as a process engineer responsible for a designated area of ownership within the project and manufacturing area.
Responsible for project management aspects including project schedule budget and coordination of multi-disciplinary teams.
Support Environmental Health & Safety activities including Process Hazard Analysis Pre-Startup Safety Review and Process Safety Management 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
Bachelors or Masters Degree in Mechanical Electrical Chemical (or BioChem) Manufacturing Engineering or equivalent education/experience.
4-6 years of combined experience in a FDA regulated environment such as: pharma/biopharma and/or fine chemicals industry to include 3 years of 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.
2 years of experience participating in small to large-sized projects through all phases including design design review process hazard analysis equipment procurement installation commissioning and qualification is desirable
Preferred Qualifications
Familiarity with current ASME BPE sanitary piping and equipment design standards electrical standards such as National Fire Protection Association / National Electrical Code (NFPA 70 / NEC) and International Fire and Building Codes.
Experience with Biotechnology equipment platforms (Purification Ultrafiltration Clean In Place etc).
Experience with industrial control systems including SCADA PLCs and BAS and validation documentation including installation operational and performance qualification (IQ/OQ/PQ) protocols.
Familiarity with AutoCAD Revit or Visio is a plus!
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-disciplinary teams including process development manufacturing validation quality safety and project management personnel.
Additional Details
This job has a full time weekly schedule. Applications for this job will be accepted until at least August 26 2025 or until the job is no longer posted.The full-time equivalent pay range for this position is $97920.00 - $153000.00/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: 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 or contact 1-. For more information about equal employment opportunity protections please visit Required: OccasionalShift:
DayDuration:
No End DateJob Function:
ManufacturingEmployment Type
Full-Time
