IMPAX LABORATORIES, INC
An FDA regulated pharmaceutical company
Job Title: Engineering Co-op
Department: Engineering
Reports to: Director of Production Engineering
Summary: This is an excellent opportunity for an
engineering student to learn first hand how a
maintenance department functions by assisting
with the various documentation and programs. The
Co-op will also have the opportunity to learn
about the repair and maintenance of manufacturing
process and facility equipment used in the
pharmaceutical industry, which includes, but not
limited to Tablet Press Machines, Tablet Coaters,
Encapsulators, Drying Ovens, Glatt Fluid Bed
Granulators, Mills, Boilers, Chillers, Air
Compressors, Oxidizers systems, and other
miscellaneous production machines and
equipment. Engineering students with two or more
years of education should easily master the
requirements of this position in a matter of a few weeks.
Essential Duties & Responsibilities will be
taught over several months. Duties &
Responsibilities include, but not limited to the following:
Other duties may be assigned.
* Primarily responsible for the support of
the spare parts inventory and program. This
entails conducting periodic assessment of the
inventory levels, establishing new location for
new parts, establishing min/max levels,
establishing reorder quantities and reorder
levels, entering parts received into the CMMS and
then into the spare parts cabinets. Taking out
parts to be used from the CMMS and from the spare
part cabinets. Putting together a critical spare
parts binder with drawings and a list for each
piece of equipment/system and then comparing the
lists with the parts currently in inventory to
check for any gaps and then work to close the
gaps. Initiates purchase order for spare parts, as directed.
* Responsible for the Preventative
Maintenance Programs This includes re-writing
some PMs and submitting the revised documents
through change control. This also includes
tracking new or revised documents through the
change control process such as SOPs (Standard
Operation Procedures) and IRs (Investigative
Reports). PMs are to be reviewed to ensure each
one has all the special tools and parts listed,
and include enough detail to perform the work,
each step has an action step for each check
(i.e., inspect belts and replace if ….),
includes specific oil or grease by name and per
the department list of oils carried in-stock.
* Responsible for the organization, safety
and general housekeeping of the maintenance
area. This includes organizing spare parts and
larger parts that need to be store on shelving
and organizing miscellaneous parts such as
electrical, plumbing, mechanical, etc. Also
includes re-stock parts that are not used.
* Help organize and maintains a maintenance
drawing and technical manual library.
* Work with Production, Engineering and
Maintenance to write and / or revise equipment set-up sheets.
* Identifies and initiates value added
opportunities for continuous improvement in
existing procedures, processes or equipment.
· Follows all cGMPs and ensures that
product is manufactured according to procedure
and current Good Manufacturing Practices.
· Follows safe working practices while
performing assigned duties. Identifies reports
and may recommend corrective action for any
unsafe conditions to a supervisor, or department
manager. Adheres to safety procedures including,
but not limited to wearing product specific
Personal Protective Equipment (PPE) requirements,
safety glasses, lock out, confine space and other
company policies and procedures.
Competencies:
To perform the job successfully, an individual
should demonstrate the following competencies:
· Technical Skills - Pursues training and development opportunities.
· Oral Communication - Listens and gets
clarification; effectively communicates.
· Written Communication - Writes clearly,
technically and informatively.
· Teamwork - Contributes to building a positive team spirit.
· Project management – Organizes and coordinates maintenance projects
· Organizational Support - Supports organization's goals and values.
· Quality - Demonstrates accuracy and thoroughness.
Qualifications: To perform this job successfully,
an individual must be able to perform duties that
meet or exceed expectations. 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/or Experience:
Must have:
· At lease two years of schooling towards an Engineering degree.
· Very good supervisory
skills. Must demonstrate strong technical skills
in instrumentation calibration and
troubleshooting for both manufacturing and laboratory.
Language Skills: Excellent command of the
English language to read and comprehend complex
instructions, and especially to write
correspondence, reports and memos. Ability to
effectively present information in one-on-one and
small group situations to other employees of the
organization. Ability to read and interpret
documents such as safety rules, operating and
maintenance instructions, and procedure manuals.
Mathematical Skills: Candidate should have the
ability to add, subtract, multiply and divide
using the metric system and to perform these
operations as required for calibrations.
Reasoning Ability: Candidate should have the
ability to solve practical problems and deal with
a variety of situations where only limited
standardization exists, to interpret a variety of
instructions furnished in written, oral, diagram,
or schedule form, to apply common sense
understanding to carry out complex instructions
and to deal with complex situations with several variables.
Other skill and Abilities: Must have a strong
working knowledge and experience of Microsoft
Office. Working knowledge of a Computerized
Maintenance Management System a plus.
Physical Demands: The physical demands described
here are representative of those that must be met
by an employee to successfully perform the
essential functions of this job. Reasonable
accommodations may be made to enable individuals
with disabilities to perform the essential functions.
While performing the duties of this job, the
employee is regularly required to stand. The
employee is frequently required to walk. The
employee is occasionally required to use hands to
finger, handle, or feel; reach with hands and
arms; climb or balance; stoop, kneel, crouch, or
crawl and talk or hear. The employee must
frequently lift and/or move up to 50 pounds. The
employee must have the ability to climb all types
of ladders and work in confined spaces. Specific
vision abilities required by this job may include
close vision, color vision, depth perception, and ability to adjust focus.
Work Environment: The work environment
characteristics described here are representative
of those an employee encounters while performing
the essential functions of this job. Reasonable
accommodations may be made to enable individuals
with disabilities to perform the essential functions.
The employee must wear all the required GMP
garments and safety equipment including, but not
limited to all types of respirators, safety
harnesses, etc. as the job requires.
Employee must be flexible to work overtime and/or
different shifts as business needs dictate.
Best regards,
Michael Yoon
Associate Director of Human Resources
Impax Laboratories, Inc.
myoon@impaxlabs.com
<http://www.impaxlabs.com/>www.impaxlabs.com
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