Responsible for the sites 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
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
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
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
Performs other duties as assigned.
Responsible for periodic revalidation of major process equipment in Clinical
Pilot Plants and in Commercial Facilities.
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.
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).
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.
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
to answer validation questions and interact with various regulatory agencies.
validation reviewer for operation's SOP's with validation cycle parameters and
possess ability to quickly address operations issues with equipment validated
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.
Bachelors 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
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
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.
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
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
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
Location/Region: Mineral Point, PA