Process Engineer
Process Engineer
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$ 97920 - 153000
1 Vacancy
Job Description
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 forwardthinking team but also to lead in the design and implementation of complex manufacturing processes and transform broad concepts into structured resultsfocused projects.
Join a growing team with this exciting new opportunity for an Process Engineer at our Boulder Colorado GMP facility. Work in our dynamic fastpaced APIBiopharma manufacturing environment with the ability to contribute to the growing industry of oligonucleotide (DNARNA) based therapeutics.
Responsibilities may include but are not limited to:
- Provide project/process engineering support of a GMP manufacturing process (Upstream Midstream Downstream Utilities).
- Responsible for any area of focus with the existing manufacturing process. Area of focus will also be supported during projects.
- Supporting 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 turnover to manufacturing.
- Participate with project management through coordination of multidisciplinary teams.
- Collaborate with Chemical Development and Manufacturing Services groups with activities such as technical transfer and scaleup of processes into manufacturing.
- Collaborate and facilitate project 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 regulatory 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 daytoday troubleshooting and maintenance activities for projects/process through identification of process improvement and optimization opportunities including review of SOPs and MBRs.
- Perform job functions and responsibilities independently and with limited direction.
- Leads the development design of new product/ process technology advancements; is the key technical contributor.
- Solves complex high impact design/ development problems
Qualifications
Required
- Bachelors or Masters Degree in Mechanical Electrical or Chemical Engineering or equivalent education/experience
- 4 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.
Desired
- 2 years of experience supporting small to largesized projects through all phases including design design review process hazard analysis equipment procurement installation commissioning and qualificationn is desirable.
- Selfmotivated handson problem solver with the ability to work within multidisciplinary teams including process development manufacturing validation quality safety and project management personnel.
- 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 experience in 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.
- Engineering communication and organizational skills to support the safe efficient and compliant production of API within a fastpaced dynamic contract manufacturing facility.
Additional Details
This job has a full time weekly schedule. Applications for this job will be accepted until at least May 15 2025 or until the job is no longer posted.The fulltime 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 jobrelated 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. For more information about equal employment opportunity protections please visit Required: 10% of the TimeShift:
DayDuration:
No End DateJob Function:
ManufacturingEmployment Type
Full-Time
