Process Engineer, Operational Excellence in Albuquerque, NM at AMRI

Date Posted: 3/10/2020

Job Snapshot

Job Description

Description
Process Engineer Albany Molecular Research Inc. provides global contract research and manufacturing services to the pharmaceutical and biotechnology industries.   

Summary:

TheProcess Engineer/Specialist is responsible for the technical support (LEAN andimprovements) of specifically their assigned area. They also support othermembers of the group by assisting in technical support in all areas of thefacility. Process improvements are conducted through the use of Lean Six Sigma(LSS) tools/process. This position must be able to effectively manage, lead,and problem solve both technically and managerially in a dynamic manufacturingsetting. Process Engineer/Specialist isrequired to have a general working knowledge of the facility as a whole.

Essential Dutiesand Responsibilities:

  • Responsiblefor rapid change in specified production areas with the use of LSS, as requiredor suggested.

  • Writes User Requirement Specifications for new equipment/ technology.

  • ApplyLSS tools to investigation and Problem Reports, as required or suggested.

  • Use dataanalyzing tools to evaluate data collected from the processes in your area toevaluate and maintain the processes.

  • Createand maintain control charts, and trending data, from your assigned area tocommunicate and improvements.

  • Responsiblefor value stream mapping of production areas, equipment and processes.

  • Trainingof employees on equipment and processes.

  • Trainingof employees on LSS tools and skills, as required or suggested.

  •  Support Highly Potent Compound initiatives.

  • Supportfacility and department Objectives.

  • Implements improvements to the Operations processand equipment related to their area of responsibility.

  • Identifies and analyzes new technologies that may bebeneficial to the company. Creates documents for Operations processes anddevelops strategies for improving the performance of the Operations Department.

  • Cover gaps within processes and systems throughoutthe facility as needed. Completeschange controls related to MBRs, SOPs, PRs, compliance, new products, equipmentchanges/enhancements, and process improvements.

  • Workswith customers, Project Managers, Tech Ops, Operations Excellence, Operations,Maintenance, and Engineering to coordinate activities in accordance withplanned schedules, customer specifications, and established quality standards.

  • Actively pursue LEAN of processes and improvements(minimum of 1 project at all times).

  • Participates in, or leads, Operations Excellenceprojects (i.e. Black Belt projects, Green Belt projects, Kaizen events), asrequired or suggested.

  • Maintains up-to-date training, including safety.Training personnel in new processes or process enhancements, as required.

  • Maintains a floor presence to continually look forareas of improvement and provide support to the Operations Department. Support daily activities in your area ofresponsibility (including asking the manufacturing team routinely (daily-weeklyminimum) what their needs area).

  • Investigate delays, trends, equipment issues anditems that adversely impact product capabilities in your area.

  • Trend PR and equipment issues within your area toeffectively address problems.

  • Monitors and reports progress of projects withinagreed timelines ensuring goals are met.

  • Responsible for maintaining up-to-date timelines andmeeting agreed upon deadlines.

  • Consults and advises upper management of projectstatus and reports issues that may affect ultimate results.

  • Able to work with little or no guidance or supportto improve equipment and processes. Able to leverage the Tech Ops team andresources around you to be more successful.

  • Able to think rationally about issues, obstacles andconcerns to make appropriate decisions and evaluate to a high level whenrequired.

  • Responsiblefor reviewing all SOPs for completeness, content and clarity, writing ProblemReports (PR’s), and performing training associated with such. Exercisesjudgment within broadly defined practices in selecting techniques andsolutions. 

  • Demonstratessuccess in technical proficiency as it pertains to AMRI ABQ systems andpractices, collaboration with others and independent thought.

  • Responsiblefor ensuring compliance with cGMPs, corporate and site-specific policies, andprocedures.

  • Must beable to work on equipment and write procedures for your area. Must be gownqualified and media qualified and maintain certification.

  • Assistother Process Specialists/Engineers and support their training. Facilitatecommunication for the group.

  • Properlydocument project and meeting with timelines, scope, agenda and post meetingnotes or updates.

  • Otherduties as assigned

SupervisoryResponsibilities:  

This job has nosupervisory responsibilities.


Qualifications

Education and/orExperience:

Aminimum of BS with an emphasis in Engineering and minimum of 3 years directlyapplicable experience,

Aminimum of BS in related field (to Process Improvement, Engineering, Mechanicsor Pharmaceuticals) and minimum of 5 years directly applicable experience inthe industry, or a minimum of a Bachelors (in any field), Lean Trained anddirect related experience of 5 years or more.

 

 

Language Skills:

Abilityto read, analyze, and interpret general business periodicals, professionaljournals, technical procedures, or governmental regulations.  Ability to write reports, businesscorrespondence, and procedure manuals. Ability to effectively present information and respond to questions fromgroups of managers, clients, customers, and the general public.

MathematicalSkills:

Abilityto calculate figures and amounts such as discounts, interest, commissions,proportions, percentages, area, circumference, and volume.  Ability to apply concepts of basic algebraand geometry.

 

Reasoning Ability:  

Abilityto define problems, collect data, establish facts, and draw valid conclusions.Ability to interpret an extensive variety of technical instructions inmathematical or diagram form and deal with several abstract and concretevariables.

Computer Skills:

Toperform this job successfully, an individual should have knowledge of MSProject Management software; Excel Spreadsheet software and MS WordWord Processing software.

Other Skills andAbilities:

  • Solidknowledge of a sterile processing environment. Proficient with Windows, Microsoft Word, MS Project, and Excel computerprograms. 

  • Abilityto interpret a variety of instructions furnished in written, oral, diagram, orschedule form.

  • Abilityto perform independent work related to projects and/or routine activities


  • Abilityto be an author for protocols or reports, or other non-routine activities.
  • Abilityto review reports, etc. for accuracy and logic.

  • Abilityto meet deadlines and work under pressure.

  • Abilityto learn independently about equipment and processes.

  • Abilityto work collaboratively with many departments and personalities.

  • Abilityto be self-motivated.

  • Abilityto obtain Lean Six Sigma certification and maintain certification.

  • Must beable to obtain and maintain gowning qualifications.

 

 

OtherQualifications:

Must pass background check

Must pass drug screen  

 

Physical Demands:

While performing theduties of this job, the employee is regularly required to talk or hear. Theemployee is frequently required to sit and use hands to finger, handle, orfeel. The employee is occasionally required to stand; walk; reach with handsand arms; climb or balance and stoop, kneel, crouch, or crawl. The employeemust regularly lift and /or move up to 10 pounds, frequently lift and/or moveup to 25 pounds and occasionally lift and/or move up to 50 pounds.  Specific vision abilities required by thisjob include close vision, distance vision, color vision, peripheral vision anddepth perception.

 

Work Environment:

While performing theduties of this job, the employee is occasionally exposed to moving mechanicalparts; high, precarious places; fumes or airborne particles; toxic or causticchemicals; risk of electrical shock; explosives; risk of radiation andvibration. The noise level in the work environment is usually moderate.


Albany Molecular Research, Inc. is committed to providing equal opportunity to all job seekers including qualified individuals with disabilities. If you have any difficulty using our online application system due to a disability or believe you need a reasonable accommodation to search for a job opening or submit an application, you may use the alternative email address jobs@amriglobal.com to contact us about your interest in employment or you may call us at 518.512.2000. Please note: The above-referred email address and telephone number are dedicated communication lines designed exclusively to assist job seekers whose disability prevents them from being able to apply online. Messages left for other purposes will not receive a response.

Job: Operations
Primary Location: US-NM-Albuquerque
Other Locations:
Organization: AMRI Albuquerque
Schedule: Full-time
Job Posting: Mar 10, 2020, 4:25:20 PM
Shift Type: Standard 8

AMRI is committed to providing equal opportunity to all job seekers including qualified individuals with disabilities. If you have any difficulty using our online application system due to a disability or believe you need a reasonable accommodation to search for a job opening or submit an application, you may use the alternative email address jobs@amriglobal.com to contact us about your interest in employment or you may call us at 518.512.2000.

Please note: The above referenced email address and telephone number are dedicated communication lines designed exclusively to assist job seekers whose disability prevents them from being able to apply online. Messages left for other purposes will not receive a response.