Off- Shift Bio- Technician Level 1

Job Description

We are seeking a highly skilled and detail-oriented Bio-Technician to join our team.

Bio- Technician Level 1

Function (Essential functions of the position include, but are not limited to the following):

• Following the appropriate SOPs, MPDs and other pertinent documentation, performs all functions required to produce vaccines.

• Maintains production records, physical inventory and accounting reports, instructs and directs assigned personnel; maintains in-process checks and assists in developmental work pertaining to production methods when required. Documents all work according to proper cGMP documentation practices and performs review of manufacturing documentation.

• Performs all work duties via automated systems or manual operations in compliance with safe operating procedures, company and government regulations, and good manufacturing practices.

• Process monitoring documentation and process review will be completed as required to ensure that only the highest quality product is released.

• Cleans, assembles, operates, disassembles, maintains, trouble shoots and initiates corrective actions as required to meet production schedules.

• Trains personnel on approved processes and procedures.

• Dispose of Process waste material as per departmental SOP and regulatory guidelines.

Equipment (including but not limited to):

• ANALYTICAL EQUIPMENT (e.g. pH meters, conductivity meters, spectrophotometer, pipettes, off-gas analyzer and Biolyzer)

• AUTOMATED SYSTEMS (e.g. DCS, robotics)

• CIP SYSTEMS (automated and manual)

• CLEANING EQUIPMENT AND SUPPLIES (e.g. mops and disinfectants)

• DECONTAMINATION EQUIPMENT (e.g. autoclaves and tanks)

• IDENTIFICATION SYSTEMS (e.g. labeling devices)

• MAINTENANCE EQUIPMENT (e.g. tools and calibration equipment)

• MATERIAL HANDLING EQUIPMENT (e.g. hand jacks, carts, hand trucks, hoists, biosafety cabinets, chemical fume hoods, freezers, thaw baths and pumps)

• PROCESS VESSELS (e.g. tanks, fermentors, portable banks, bags and bottles)

• SEPARATION SYSTEMS (e.g. filters, centrifuges, and chromatography equipment)

• WEIGHMENT SYSTEMS (e.g. scales, balances)

• ENVIRONMENTAL MONITORING EQUIPMENT (e.g. SMA, particle counters)

• COMPUTER SYSTEMS (e.g. IMPACT, NGL, HanDEL)

• SPECIAL LABORATORY EQUIPMENT (e.g. microscopes, centrifuge, pumps)

Duties:

• Working in conjunction with all appropriate personnel, performs manual and automated operations, general maintenance, and support functions necessary for the production of vaccines.

• Participates in and assists with the development and execution of personnel training.

• Revises and authors SOPs and GMP documentation.

• Serves on safety, quality and other committees as required.

• Provides all documentation and clerical functions necessary to allow proper accountability and traceability of product.

• Maintains, inventories, and transports all required equipment, materials, supplies and products.

• Ensures shipment criteria and timely availability and delivery.

• Demonstrates proficiency with Distributed Control System and other automated systems (including, but not limited to, NGL, WATS, HanDEL, Word, Excel, and IMPACT).

• Performs general maintenance and assists in troubleshooting of equipment.

• Performs housekeeping in all work areas.

• Executes facility decontamination according to approved procedures.

• Performs sampling/in-process testing supporting the manufacturing and validation processes for current process as well as developmental work for new products/processes as required.

• At the start and finish of each shift, reports and makes recommendations regarding equipment supplies, required repairs, process concerns, safety concerns, and area for improvements.

• Immediately notifies the appropriate personnel of compliance, environmental, safety, and process deviations.

• Maintains, cleans, and prepares equipment used in vaccine production.

• Schedules and performs environmental monitoring during processing and records results in the computerized database system.

• Performs all job functions of Support Associate or Clerk as required.

• Delivers all samples and other materials as required to appropriate laboratories.

• 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.

• Level 2 employees demonstrate sustained proficiency in all skills identified in and required by Level 1 employees.

Position Qualifications:

Education Minimum Requirement:

• Bachelor's Degree in chemistry, biology, biochemistry, microbiology, molecular biology or life sciences, chemical, biochemical engineering or other relevant science/engineering program.

Experience:

NECESSARY: Satisfactorily demonstrating proficiency in all the skills required by a Level 1 employee, within subunit. Must satisfactorily meet requirements of a Biotech level 1 within 7 months.

Equipment or Machinery Operated:

Automated systems such as Distributed Control System (DCS) an automated process control system that governs the operation of most equipment. POMS, LIMS and IMPACT. Analytical, monitoring, and laboratory/manufacturing equipment, including but not limited to: centrifuge equipment, spectrophotometers, pH and conductivity meters, scales, balances, filtration equipment, chromatography columns, off-gas analyzer, pumps and sampling assemblies, refrigerators, and CTUs. Process vessels such as fixed and portable tanks, fermentors, bags and bottles. Safety: personal protective equipment such as respirators, hearing protection, and other personal protective clothing. Biosafety cabinets and chemical fume hoods. Material handling equipment such as drum lift, hand jacks, carts, hoists, and pumps. Decontamination and cleaning equipment such as autoclaves, disinfectants, and mops.

Special Skills or Abilities:

Ability to perform aseptic/sterile operations.  Mechanical aptitude and ability to analyze equipment and take appropriate corrective action. 

Special Job Features:

Some heavy lifting. Sterile technique. Ability to plan ahead; follow oral and written instructions, maintain neat, accurate and current records. Alertness to detail and safety regulations. Accuracy in laboratory measurements. Dexterity in production procedures. All female applicants who are pregnant must report to Health Services to evaluate the hazards of this position and possible job restrictions. Use of safety and personal protective equipment and clothing such as safety glasses, gowns and respirators as listed in departmental SOPs, JOSHA sheets, etc; dust; malodors; subject to immunizations; shift work; work in areas with elevated noise levels or concentrations of hazardous materials. Handles live organisms and chemical substances. Handles concentrated chemicals and substances, which can cause serious chemical burns to unprotected skin. Flexibility in shifts worked and scheduling daily activities. Candidate must be willing to work as part of a team. All incumbents will be required to obtain all required titers, including but not limited to Mumps, Measles, Rubella, Varicella and Hepatitis A. All subunit 248 employees handle live black widow spiders.

NOTICE FOR INTERNAL APPLICANTS

In accordance with Managers' Policy - Job Posting and Employee Placement, all employees subject to this policy are required to have a minimum of twelve (12) months of service in current position prior to applying for open positions.

If you have been offered a separation benefits package, but have not yet reached your separation date and are offered a position within the salary and geographical parameters as set forth in the Summary Plan Description (SPD) of your separation package, then you are no longer eligible for your separation benefits package. To discuss in more detail, please contact your HRBP or Talent Acquisition Advisor.

Employees working in roles that the Company determines require routine collaboration with external stakeholders, such as customer-facing commercial, or research-based roles, will be expected to comply not only with Company policy but also with policies established by such external stakeholders (for example, a requirement to be vaccinated against COVID-19 in order to access a facility or meet with stakeholders).  Please understand that, as permitted by applicable law, if you have not been vaccinated against COVID-19 and an essential function of your job is to call on external stakeholders who require vaccination to enter their premises or engage in face-to-face meetings, then your employment may pose an undue burden to business operations, in which case you may not be offered employment, or your employment could be terminated. Please also note that, where permitted by applicable law, the Company reserves the right to require COVID-19 vaccinations for positions, such as in Global Employee Health, where the Company determines in its discretion that the nature of the role presents an increased risk of disease transmission.

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U.S. Hybrid Work Model

Effective September 5, 2023, employees in office-based positions in the U.S. will be working a Hybrid work consisting of three total days on-site per week, generally Tuesday, Wednesday and either Monday or Thursday, although the specific days may vary by site or organization, with Friday designated as a remote-working day, unless business critical tasks require an on-site presence.  This Hybrid work model does not apply to, and daily in-person attendance is required for, field-based positions; facility-based, manufacturing-based, or research-based positions where the work to be performed is located at a Company site; positions covered by a collective-bargaining agreement (unless the agreement provides for hybrid work); or any other position for which the Company has determined the job requirements cannot be reasonably met working remotely. Please note, this Hybrid work model guidance also does not apply to roles that have been designated as “remote”.

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Merck & Co., Inc., Rahway, NJ, USA, also known as Merck Sharp & Dohme LLC, Rahway, NJ, USA, does not accept unsolicited assistance from search firms for employment opportunities. All CVs / resumes submitted by search firms to any employee at our company without a valid written search agreement in place for this position will be deemed the sole property of our company.  No fee will be paid in the event a candidate is hired by our company as a result of an agency referral where no pre-existing agreement is in place. Where agency agreements are in place, introductions are position specific. Please, no phone calls or emails. 

Employee Status:

Relocation:

VISA Sponsorship:

Travel Requirements:

Flexible Work Arrangements:

Shift:

Valid Driving License:

Hazardous Material(s):

Job Posting End Date:

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