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|Senior Project Engineer|
Location: Frederick All Buildings, CO
Employment Type: Full Time
Date Posted: 04/27/2021
Expire Date: 08/14/2021
Job Categories: Accounting/Auditing, Biotechnology and Pharmaceutical, Engineering, Healthcare, Practitioner and Technician, Information Technology, Installation, Maintenance, and Repair, Manufacturing and Production, Military, Quality Control, Research & Development, Medical, Writing/Authoring
Senior Project Engineer|
"What's it like to work at Agilent in Manufacturing? Watch the video"
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 www.agilent.com.
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 expert-level 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.
Responsibilities may include but are not limited to:
* Provide project management services including but not limited to schedule, coordination of resources, budget controls, and project controls to ensure delivery of capital projects on time and on budget with the highest quality standard.
* Responsible for small to large-sized capital projects throughout all phases of the project lifecycle, including the development of user requirement specifications, process design integration, equipment and instrumentation specification/selection, equipment procurement, installation, commissioning, qualification, and turn-over to manufacturing.
* Responsible for project management through coordination of multi-disciplinary teams.
* Support Chemical Development and Manufacturing Services groups with activities such as technical transfer and scale-up of processes into manufacturing.
* Ensure for all projects EHS activities including Process Hazard Analysis, Safety Checklist, and PSM compliance to meet OSHA standards.
* Ensure for all projects a high level of cGMP compliance to meet the ICH requirements for pharmaceutical buildouts.
* 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.
* Integrate with Manufacturing and Quality Assurance groups with day-to-day troubleshooting and maintenance activities for projects, through identification of process improvement and optimization opportunities, including review of SOPs and MBRs.
* Perform job functions and responsibilities independently and with limited direction.
* Reduces broad concepts, business strategies to structured projects
* Leads the development, design of new product/ process technology advancements; is the key technical contributor.
* Solves complex, high impact design/ development problems
The salary range for this position in Frederick, CO is $104,800-$163,750.
Benefits in Brief
* Bachelors or Masters Degree in Chemical Engineering or equivalent education/experience
* 5+ years of combined experience in pharma/biopharma and fine chemicals industry to include 3+ years of experience with P&IDs, facility layouts, A&E firms, PSM, equipment sizing calculations, user requirement specifications (URSs), standard operating procedures (SOPs) and process troubleshooting.
* 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 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
* Project Management certification or 3+ years' experience in project management for biopharma
* Experience with design and programming of industrial control systems including SCADA, PLCs, and BAS and 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-disciplinary teams including process development, manufacturing, validation, quality, safety, and project management personnel.
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 firstname.lastname@example.org or contact +1-262-754-5030.
For more information about equal employment opportunity protections, please see all of our notices for EEO below.
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