Off Shift Bio-Technicians Level 1 | Vaccine Manufacturing

Job Description

Are you looking for an exciting opportunity with a rapidly growing pharmaceutical manufacturer? If so, then this is the opportunity for you! We are seeking Growth and Improvement minded Bio-Technicians Level 1 | Vaccine Manufacturing that can help drive our Strategic Operating Priorities.

• Invent | Pursue the Most Promising Internal and External Science to Address Significant Unmet Medical Needs
• Execute | Prioritize Resources Behind Our Key Growth Drivers (Oncology, Vaccines, Select Specialty Areas, Animal Health) While Optimizing Our Base Business)
• Adapt | Develop Our People, Culture and Business Model to Evolve with a Dynamic Landscape
• Diverse Talent | We are committed to providing an inclusive and welcoming environment with supporting leadership behaviors because having a high-performing, engaged workforce is critical to our ability to deliver innovative solutions to patients and customers around the world
• Values and Standards | Our Steadfast Commitment to Our Values and Standards will Continue to Guide Us as We Take on New Challenges and Will Always be Fundamental to Our Success - They are a Competitive Advantage for Us

Summary, Focus and Purpose

The Bio-Technician Level 1 | Vaccine Manufacturing follows the appropriate SOPs, MPDs and other pertinent documentation and completes all functions required to produce vaccines. You will maintain 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.

This role requires you to document all work according to proper cGMP documentation practices and conducts review of manufacturing documentation.

Achieve all work duties via automated systems or manual operations in compliance with safe operating procedures, company and government regulations, good manufacturing practices and process monitoring of documentation and process review as required to ensure that only the highest quality product is released.

You will clean, assemble, operate, disassemble, maintain, trouble shoot and initiate corrective actions as required to meet production schedules and train personnel on approved processes and procedures such as disposal of process waste material as per depar1mental SOP and regulatory guidelines.

Key Functions

• Work Independently and as a Team member with Integrity | Precision | Accomplishment | Motivational Ambition | Respect | Inclusion
• Working in conjunction with all appropriate personnel, completes 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 | Provides all documentation and clerical functions necessary to allow proper accountability and traceability of product
• Serves on safety, quality and other committees
• 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)
• Conducts general maintenance and assists in troubleshooting of equipment | Completes cleaning in all work areas | Maintains, cleans and prepares equipment used in vaccine production | Executes facility decontamination according to approved procedures
• Completes sampling/in-process testing supporting the manufacturing and validation processes for current process as well as developmental work for new products/processes
• 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
• Schedules and conducts environmental monitoring during processing and records results in the computerized database system
• Completes all job functions of Support Associate or Clerk positions
• 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

Level I Training

• Process operations, in process testing and in process maintenance/system checks
• Document review and basic math skills
• Utilization of material and financial system (eg. IMPACT)
• Utilization of automated systems (e.g. NGL, HanDEL, WATS)
• Utilization of laboratory and manufacturing equipment
• Environmental Monitoring (including: scheduling, sampling, and data review)
• Inventory management and stocking
• Cleaning Safety and cGMPs including involvement in systems to maintain and improve compliance

Equipment

Analytical

• pH Meters | Conductivity Meters | Spectrophotometer | Pipettes | Off-Gas Analyzer | Biolyzer

Automated Systems

• DCS | Robotics
• CIP Systems (Automated and Manual)

Cleaning Equipment | Supplies | Decontamination

• Mops | Disinfectants
• Autoclaves | Tanks

Identification Systems | Maintenance | Material Handling

• Labeling Devices
• Tools | Calibration
• Hand Jacks | Carts | Hand Trucks | Hoists | Biosafety Cabinets | Chemical Fume Hoods | Freezers | Thaw Baths and Pumps

Process Vessels | Separation Systems

• Tanks | Fermentors | Portable Banks, Bags and Bottle
• Filters | Centrifuges and Chromatography

Weighment Systems | Environmental Monitoring

• Scales Balances
• SMA | Particle counters

Computer Systems | Special Laboratory

• IMPACT | NGL | HanDEL
• Microscopes | Centrifuge | NMNNs

Safety

• Personal Protective: Respirators | Hearing Protection | Other Personal Protective Clothing

Education

• Bachelor degree in chemistry, biology, biochemistry, microbiology, molecular biology or life sciences, chemical, biochemical engineering or other relevant science/engineering program
• Passing Skills Assessment Test

Experience | Skills | Knowledge

Required

• Successfully demonstrate and maintain proficiency in aseptic techniques and aseptic gowning by passing monitoring testing
• Principled verbal and written communications
• Continue to progress towards attaining a Level 2 position by completing training on required skills
• Mechanical aptitude and ability to analyze equipment and take appropriate corrective action

Preferred

• Laboratory or manufacturing operations experience requiring aseptic or sterile technique
• Working in a GMP facility
• Automated system or computer experience

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.

Current Employees apply HERE

Current Contingent Workers apply HERE

US and Puerto Rico Residents Only:

Our company is committed to inclusion, ensuring that candidates can engage in a hiring process that exhibits their true capabilities. Please click here if you need an accommodation during the application or hiring process.

For more information about personal rights under Equal Employment Opportunity, visit:

EEOC Know Your Rights

EEOC GINA Supplement

Pay Transparency Nondiscrimination

We are proud to be a company that embraces the value of bringing diverse, talented, and committed people together. The fastest way to breakthrough innovation is when diverse ideas come together in an inclusive environment. We encourage our colleagues to respectfully challenge one another's thinking and approach problems collectively. We are an equal opportunity employer, committed to fostering an inclusive and diverse workplace.

U.S. Hybrid Work Model

Effective September 5,2023 our U.S. Hybrid work model will be as follows: 1. Three total days on site per week: Tuesday and Wednesday - plus one additional day of choice based on what works best for organizations and/or teams. 2. Fridays will formally be a remote-working day unless business critical tasks require onsite presence.

Learn more about your rights, including under California, Colorado and other US State Acts

Search Firm Representatives Please Read Carefully
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:
Regular

Relocation:
No relocation

VISA Sponsorship:
No

Travel Requirements:
No Travel Required

Flexible Work Arrangements:
On-Site

Shift:
2nd - Evening, 3rd - Night

Valid Driving License:
No

Hazardous Material(s):
n/a

Requisition ID:R253412