Responsible for the site's equipment maintenance and instrument calibration processes. Provides technical and organizational support and leadership to drive equipment reliability and performance improvement increasing Overall Equipment Effectiveness (OEE), and Mean Time Between Failures (MTBUF), as well as implement systems and best practices to ensure proactive measures are being taken for continuous improvement. Facilitates a vibration, ultrasonic, and thermography program for facility operational equipment and utility systems.
Responsible for conducting and delivering analytical and engineering studies to support cleaning validation, cleaning verification, thermal sterilization, thermal sanitization, and controlled temperature unit mapping for major GMP clinical and commercial equipment and facilities.
Write, approve, execute, and close-out validation reports.
Maintain GMP status of assigned suite areas and facilities.
Responsible for project management to set and meet lead times for cleaning and sterile validation testing, elevate need for additional resources, and ensure equipment periodic revalidations stay on schedule.
This position is on a client account within the pharmaceutical industry.
ESSENTIAL DUTIES AND RESPONSIBILITIES
Defines, designs, develops, monitors and refines an asset's maintenance plan that includes: value added preventative maintenance tasks, effective utilization of predictive and other non-destructive testing methodologies designed to identify and isolate inherent reliability problems.
Provides technical support to the site engineering teams for mechanical equipment and mechanical fixed assets (Pressure Systems Safety Regulations, Condition Based Monitoring, Risk Based Inspection).
Works with engineering and operations teams to perform analyses of assets including: overall equipment effectiveness, remaining useful life, other parameters that define operation condition, reliability and costs of assets.
Develops risk management plans that will anticipate reliability related and non-reliability related risks that could adversely impact plant operations.
Applies value analysis to repair/replace, repair/redesign and make/buy decisions.
Performs other duties as assigned.
Responsible for periodic revalidation of major process equipment in Clinical Pilot Plants and in Commercial Facilities.
Conduct field cleaning validation testing including performance of visual inspection, and the collection of rinse water samples, swab samples, and/or extraction samples. Equipment will include: bioreactors, fixed tanks, transfer lines, chromatography skids, filtration skids, portable vessels, centrifuges, homogenizers, ultrasonic washers, glasswashers, lyophilizers, vial washers,
chromatography columns, filter carts, and filter housings.
Conduct thermal validation testing using thermocouple sensors and data collection instruments on equipment including GMP autoclaves, decon autoclaves, waste inactivation systems, dry heat ovens, lyo cabinets, bioreactors, holding tanks, portable tanks, transfer lines, and controlled temperature units (CTUs).
All work includes protocol write-up, sampling plan generation, scheduling, Lock Out/ Tag Out, testing, report write-up, review, approval, and closeout.
Lock Out/ Tag Out participation is to ensure zero energy of equipment and permit safely breaking into lines for testing.
Practice highest regard for Safety: Work with potentially dangerous systems, some which utilize high pressures and temperatures. Perform validation review and support for pilot plant campaign and master cell bank readiness plans.
Act as Subject Matter Expert (SME) on periodic re-validation of commercial product equipment and manufacturing.
Possess ability to answer validation questions and interact with various regulatory agencies.
Act as validation reviewer for operation's SOP's with validation cycle parameters and possess ability to quickly address operations' issues with equipment validated cycles.
No formal supervisory responsibilities in this position. May provide informal assistance such as technical guidance and/or training to coworkers. May coordinate work and assign tasks.
To perform this job successfully, an individual must be able to perform each essential duty satisfactorily. The requirements listed below are representative of the knowledge, skill, and/or ability required.
Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.
EDUCATION and EXPERIENCE
Bachelor's Degree in Mechanical Engineering with a minimum of 2+ years related industry experience.
Experience with instrumentation & control, computerized maintenance management systems required. Programming with emphasis of object oriented and relational databases.
B.S. / B.A. in Engineering or Science preferred
1 to 3 years relevant experience in pharmaceutical validation testing discipline
CERTIFICATES and/or LICENSES
Excellent written and verbal communication skills. Strong organizational and analytical skills. Ability to provide efficient, timely, reliable and courteous service to customers. Ability to effectively present information.
Requires knowledge of financial terms and principles. Ability to calculate intermediate figures such as percentages, discounts, and/or commissions. Conducts basic financial analysis.
Ability to comprehend, analyze, and interpret documents. Ability to solve problems involving several options in situations. Requires intermediate analytical and quantitative skills.
OTHER SKILLS and ABILITIES
Must possess a thorough knowledge of the use, setup and operation of Windows-based computers and desktop applications such as MS-Word and MS-Excel.
SCOPE OF RESPONSIBILITY
Decisions made with understanding of procedures and company policies to achieve set results and deadlines. Responsible for setting own project deadlines. Errors in judgment may cause short-term impact to co-workers and supervisor.
Responsible for personal safety and the safety of those who are affected by your work. This includes but is not limited to: Complete all required and assigned HSE training at a satisfactory level, Follow all activity policies and procedures, including all HSE-related requirements at all times, Participate in all HSE-related programs & activities as required, including incident investigations, interviews, auditing and assessment, etc. Report any conditions which you feel could result in an accident or injury and / or stop work if required.
Internal Number: 19040064
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