Manager, Process Engineering

$124,160 - $194,000/Yr

Agilent Technologies - Frederick, CO

Full-time - Manager

Frederick, CO

Professional, Scientific, and Technical Services

About the position

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 Engineering Manager 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 the ongoing expansion project that expects to grow and expand the Oligo-manufacturing capability of our Frederick Colorado site.

Responsibilities

• Lead a team of engineers through the varying stages of a large capital expansion.
• Support design, construction, commissioning and qualification activities for newly created capital projects from concept design through validation of new processes.
• Collaborate with Design Firm, Equipment Suppliers, Constructors and all other cross functional teams.
• Responsible for supporting a wide variety of capital projects throughout all phases of the project lifecycle.
• Develop 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 Services groups with activities such as technical transfer and scale-up of processes into manufacturing.
• 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 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.

Requirements

• Bachelors or Masters Degree in Mechanical, Electrical, Chemical (or BioChem), Manufacturing Engineering or equivalent education/experience.
• 1+ years experience formally or informally leading people, projects and/or programs for entry to this level.
• 8+ years of combined experience in pharma/biopharma and fine chemicals industry.
• 6+ 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.
• 4+ 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.

Nice-to-haves

• Managerial/Supervisory experience is highly preferred.
• 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 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, Revit, 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.

Benefits

• Full-time equivalent pay range for this position is $124,160.00 - $194,000.00/yr plus eligibility for bonus, stock and benefits.