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 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 may include but are not limited to:

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, 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 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 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

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

Desired qualifications:

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

Additional Details

This job has a full time weekly schedule. Applications for this job will be accepted until at least October 8, 2024 or until the job is no longer posted.

The full-time equivalent pay range for this position is $121,600.00 - $190,000.00/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 RequiredOccasional

ShiftDay

DurationNo End Date

Job FunctionManufacturing