Packaging Mechanical Technician - Trainee (2nd & 3rd Shift)

Employer
Merck
Location
West Point, PA, US
Posted
March 02 2018
Discipline
Other
Organization Type
Pharma
Requisition ID: USW001815

Merck & Co., Inc. Kenilworth, N.J., U.S.A. known as Merck in the United States and Canada, is a global health care leader with a diversified portfolio of prescription medicines, vaccines and animal health products. The difference between potential and achievement lies in the spark that fuels innovation and inventiveness; this is the space where Merck has codified its 125-year legacy. Merck’s success is backed by ethical integrity, forward momentum, and an inspiring mission to achieve new milestones in global healthcare.

Merck Manufacturing Division, MMD, is a team of dedicated, energetic individuals who are committed to being the most trusted supplier of pharmaceuticals and health products worldwide. Our facilities, along with our external contractors, suppliers, and partners, comprise an interdependent global manufacturing network that’s committed to delivering a compliant, reliable supply to customers and patients on time, every time, across the globe.

This is a Union Position. 
Our ability to excel depends on the integrity, knowledge, imagination, skill, diversity and teamwork of an individual like you. To this end, we strive to create an environment of mutual respect, encouragement and teamwork. As part of our global team, you’ll have the opportunity to collaborate with talented and dedicated colleagues while developing and expanding your career.

Currently, we have several openings across 2nd and 3rd shifts for Sterile & Packaging Operations Technician Trainee for the Merck Manufacturing Division at our West Point, PA site. Under the direction of a supervisor, performs a wide variety of tasks and operations in GMP, aseptic and controlled environments that are required to support and execute production. This includes:
  • Formulating bulk product and culture media, performing cleaning and sterilization of equipment, setting-up and operating filling equipment, staging and loading components and bulks, setting-up and operating inspection equipment, setting-up and operating the nitrogen tunnels for freezing, completing lyo cabinet operations, staging and loading packaging components, setting-up and operating packaging equipment, and completing associated batch record and logbook documentation. 
  • Operates and maintains assigned equipment in SPO by performing mechanical, electronic, electrical, and pneumatic/hydraulic troubleshooting and repairs. 
  • Completes preventative maintenance and repairs as assigned for the equipment and facilities within Sterile and Packaging Operations. 
  • Performs cleaning and housekeeping requirements as assigned in the areas. 
  • Performs all duties of other classifications in Sterile and Packaging Operations as assigned by supervision.
  • Performs in a leadership role to coordinate and execute line/equipment set-up, start-up, and on-going operations on a daily basis.
  • Provides real-time status of the operation of a line or individual piece of equipment and guides the activities of other classifications assigned to a specific operation or production activity to ensure effective operation of the equipment and completion of scheduled activities. 
  • Responsible for completing documentation as assigned by supervision to monitor the performance of equipment and line operations; and participates in team meetings to focus on increased performance and safety of the equipment in each operating area. 
All operations will be carried out in compliance with cGMP's, specific Manufacturing Process Descriptions, and Standard Operating Procedures to ensure that the quality of our products and services is of the highest level.

Equipment:

All equipment used for cleaning, upkeep, maintenance and repair of production equipment and facilities.
This includes, but is not limited to:
  • Equipment for formulation of bulk products including analytical equipment, washing, component preparation, nitrogen/lye
  • freezing, filling operations, sealing and inspection operations, material handling and packaging operations including
  • mechanical movement equipment (conveyors, etc).
  • PPE and safety equipment for processing of PBECL Level 3 and 4 compounds.
  • Personal computers, network terminals, and computer interfaces.
  • All equipment and tools used in SPO including shop gower tools and a volt-ohm-multimeter.
Duties:

  • Assists in the scheduling and coordination of the activities of the department operators and/or mechanics.
  • Assists in the planning and coordination of overtime selection and tracking.
  • Coordinates mechanical requests to ensure proper running and maintenance of all processing equipment.
  • Performs all steps associated with equipment set-up, break-down, filtrations, formulations, dilutions, thaws and pooling including calculations, process checks, pre-tests, in-process tests, and post-tests as required.
  • Performs cleaning including CIP and SIP of tanks, as well as manual washing of equipment when appropriate.
  • Interfaces with computer systems for equipment preparation and operation.
  • Maintains and controls inventory of processing equipment, components, spare parts, stockroom items and tools as directed.
  • Sets up, changes over, and test runs equipment for various size containers, stoppers and caps -as required. Makes mechanical and electrical adjustments necessary for the correct operation of the equipment. As required, performs the Hydrogen Peroxide sterilization of the filling barrier.
  • Responsible for the overall troubleshooting, repairs, and maintenance of electronic/electrical/complex mechanical and pneumatic/hydraulic systems, including coordination of outside services to affect repairs in SPO. Including, but not limited to:
    • Diagnosis of electric/electronic malfunction through the use of a multimeter.
    • Electronic - electronic control systems, their components and assorted instrumentation, programmable controllers, vision systems, industrial robots, expert systems, etc. All equipment directly or indirectly affecting the physical production of products. Makes necessary adjustments for items such as sensitivity alignment, focus, location of fiber optics, photo electric, LED, capacitance, and infrared sensors, etc.
    • Electric - all equipment and distribution systems in the department, single or three phase. May involve up toand including 240 V on a task specific basis.
    • Mechanical - all machinery related to the processing of biological and pharmaceutical products. Makes
    • necessary repairs by replacing modular or common devices or components
    • Pneumatic/hydraulic- all such devices which are components of production equipment.
  • Performs electric/electronic adjustments and modular electronic and electric replacements as necessary during set-up, repair, checkout, and line operation.
  • Performs or coordinates major and minor overhauls of formulation, vial washing, filling, packaging and inspection equipment by completely dissembling, or repairing and reassembling equipment to proper operating condition.
  • Performs preventive maintenance required to keep equipment in good working order, including but not limited to belt changes, lubrications, alignments, change outs, inspections, calibrations, etc.
  • Repairs/replaces any sanitary component, e.g., sanitary diaphragm valves connected to the system or mechanically connected valving.
  • Conducts routine microbial and particulate sampling for environmental monitoring.
  • As required, operates washing, filling, capping, inspection, and tray off equipment for normal production purposes.
  • Develops and modifies processing equipment as deemed necessary.
  • Makes periodic checks of containers/components to determine satisfactory operation of equipment.
  • Responsible for taking samples for Release, in-Process, or Validation.
  • Assists in the instruction and training o"f new operators and/or specialists in the proper performance of their duties such as proper set-up procedures, repairs, safety precautions, maintenance and operating efficiency, etc.
  • Attends training sessions, as required, to maintain skills/knowledge of process equipment.
  • Adheres to Current Good Manufacturing Practices.
  • Maintains good housekeeping and observes proper safety procedures.
  • Trainee employees will be trained in the following skills. Once proficiency has been demonstrated in a skill, employees will be responsible for performing these skills as required. Employees must demonstrate proficiency in all core skills for promotion to SPO Technician-Level 1.
    • Documentation
    • Operate Miscellaneous Equipment
    • Dose Checks, if applicable
    • Maintenance Activities
    • Setup and Operate Production Lines
    • Aseptic Techniques, if applicable
    • Sterile tube welding and filter testing, if applicable
    • SAP, if applicable
    • LIMS, if applicable
Qualifications

Education:
  • Associate’s Degree or higher in Applied Science – OR – High School Degree/GED in conjunction with equivalent Associate’s Degree program or vocational certificate – OR –equivalent military course work
NOTE: Equivalent programs will require training in courses such as:
  • Mechanical Pumps, Belts and Chain Drives
  • Lubrication and Installation of Bearings
  • Industrial Electrical 1 & 2
  • Industrial Pneumatics, Hydraulics
  • Precision Machine Shop 1 & 2
  • Equivalent experience determined by management
Required:
  • Minimum of 2 years’ working around industrial equipment
  • Must pass the MMD "Standard Timing Model" as well as the MMD Electrical standard training module
  • Must pass an annual sight screen examination (includes test for color blindness) before working in this capacity
Preferred:
  • Experience in aseptic bulk product formulation, aseptic processing which involved making sterile connections, clean rooms, gowning or manufacturing of products in cGMP facilities using process descriptions, sample measurement, and in-process additions
  • Experience in instrumentation, detection and control devices, solid state electronics, computer mathematics, digital and analog logic and robotics.
Your role at Merckis integral to helping the world meet new breakthroughs that affect generationsto come, and we’re counting on your skills and inventiveness to help makemeaningful contributions to global medical advancement. At Merck, we’reinventing for life.

 If you need anaccommodation for the application process please email us at staffingaadar@merck.com.

 Search Firm Representatives Please ReadCarefully: 

Merckis not accepting unsolicited assistance from search firms for this employmentopportunity.  Please, no phone calls oremails.  All resumes submitted by searchfirms to any employee at Merck via email, the Internet or in any form and/ormethod without a valid written search agreement in place for this position willbe deemed the sole property of Merck.  Nofee will be paid in the event the candidate is hired by Merck as a result ofthe referral or through other means.

 Visa sponsorship is not available for this position.  For more information about personal rights under Equal EmploymentOpportunity, visit:

EEOC Poster EEOC GINA Supplement

Job: USW, LOCAL 2-86
Other Locations:
Employee Status: Regular
Travel: No
Number of Openings:
Shift (if applicable):
Hazardous Materials:
Company Trade Name: Merck

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