Merck & Co., Inc., 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. Today, we are building a new kind of healthcare company - one that is ready to help create a healthier future for all of us.
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 various openings for Sterile & Packaging Operations Technician - Level 1 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.
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 power tools and a volt-ohm-multimeter.
•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 to and including 240 Volts 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 of 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.
Special Job Features:
Exposure to high and low temperatures. Extensive standing, lifting and bending with some heavy lifting. Use of hearing protection in areas of high noise levels. Some exposure to hot water and steam and chemical substances such as disinfectants, cleaning and neutralization chemicals, PBELC Level 3 and 4 compounds. Must adhere to PPE (i.e. RACAL air-purifying helmet) and gowning requirements at all times.
Education Minimum Requirement:
High School Diploma or Equivalent, AND
Successful completion of an associate's degree in Applied Science (AAS.)
Or an equivalent associate's degree program or vocational certificate in lieu of the degree program.
Or equivalent military course work
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 as determined by management
Required Experience and Skills:
A minimum of 2 year experience as a technician in a manufacturing, military or industrial facility is required. This experience will include the set-up, changeover, assembly, disassembly, repair, operation and modifications or preventative maintenance of complex mechanical equipment. Applicants without the required experience may be considered for a trainee position so they can obtain the required experience on the job.
Must pass the MMD "Standard Timing Model" as well as the MMD Electrical standard training module.
Ability to instruct and train other employees, mechanical aptitude, ability to read blueprints, knowledge of electrical, hydraulic and pneumatic principles. Ability to handle numerous complex details of the job, and handle distractions. Mathematical skills to perform in- process calculations. Must pass an annual sight screen examination (includes test for color blindness) before working in this capacity.
Preferred Experience and Skills:
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 other highly regulated industries is also desirable. Experience in instrumentation, detection and control devices, solid state electronics, computer mathematics, digital and analog logic and robotics. Attends and actively participates in HAZOPS, waste walkthroughs, kaizen events, or any other operations, lean six-sigma, quality safety or environmental training initiatives as required.
Our employees are the key to our company's success. We demonstrate our commitment to our employees by offering a competitive and valuable rewards program. Our Company's benefits are designed to support the wide range of goals, needs and lifestyles of our employees, and many of the people that matter the most in their lives. If you need an accommodation for the application process please email us at firstname.lastname@example.org.