Sterile Products Development Technician

Job Description

Under the direction of departmental supervision, performs technical and mechanical work before, during, and after manufacturing activities, such as formulating, filtrating, filling, stoppering, capping, tray loading, nitrogen freezing, lyophilizing, inspecting, and delivering of sterile and liquid products.

Primary Responsibilities

• Cleans, disinfects, and transports manufacturing equipment and supplies, performs manufacturing area cleaning and disinfection duties, and maintains the respective area and equipment use and cleaning logs. Rinses/washes, assembles, and sterilizes equipment and components for use in production as per approved equipment drawings and SOPs.

• Performs non-sterile and aseptic manipulations for the formulation, filtration, and filling of liquid and lyophilized products as well as filling of sterile biological and pharmaceutical products as outlined in the Batch Record.

• Assembles, sets up, adjusts, maintains, troubleshoots, changes over, and operates machinery for component and equipment preparation, filter integrity testing, formulation, filling, capping, lyophilization, and inspection.

• Inspects product for quality attributes and checks work done by other inspectors.

• Maintains production records and performs and responds to in-process testing.

• Maintains dosage during filling operation by performing manual dose checks.

• Complies with standard operating procedures (SOP), company, and government regulations and good manufacturing practices (GMPs) to assure the quality of our products and services are of the highest level.

• Responsible for completing documentation as assigned by supervisor to monitor the performance of equipment and line operations, including both paper and electronic documents.

• Participates in continuous improvement activities and collaborates across other areas as necessary to ensure business needs are met.

• Performs routine, processing, and special testing for viable and no-viable particulate matter according to established procedures. Collects water samples using proper aseptic techniques.

Products manufactured within the Sterile Liquids Pilot Plant are in various stages of development and human clinical testing. They include biologics, antibiotics, vaccines and vaccine adjuvants, therapeutic proteins and pharmaceuticals, as well as infectious Biosafety Level 2, hazardous OEB 4, and radioactive chemical compounds. Given that the pilot plant supports the clinical pipeline, other new products / modalities may be introduced beyond those listed.

Education Minimum Requirements:

• High School Diploma or Equivalent (GED) AND Minimum of 30 semester hours of college including: Math and Chemistry with Lab or Microbiology with Lab OR A minimum of 1 year experience within the last 5 years as a Sterile Products Development Technician (Job Code 62086-10) or Biotechnician level 2 (job code 62081-11) OR A minimum of 1 year experience within the last 5 years as an SPO Technician (Job Code 62114-12 or 62115-10 or equivalent) WITH experience in aseptic bulk product formulation, i.e., aseptic processing which involved making sterile connections.

Required Experience and Skills:

Two years-experience setting up, disassembling, and adjusting complex industrial production equipment, e.g., packaging machinery, automatic assembling machines, machinist-type experience. This does not include the performance of routine maintenance or repairs. Two years of chemical laboratory or production experience involving frequent use of the metric system and chemicals. One year of aseptic laboratory or production experience. One year of bulk formulation (i.e., manufacturing bulk product using a process description, sampling, measurements, and in process additions) This experience must be within the last 7 years. The ability to meet all Special Job Features identified in this job description.

Preferred Experience and Skills:

If no candidate has the specific requirements above, alternate mechanical or operational experience will be considered.

We are a research-driven biopharmaceutical company. Our mission is built on the simple premise that if we “follow the science” that great medicines can make a significant impact to our world. We believe that a research-driven enterprise dedicated to world-class science can succeed by inventing medicine and vaccine innovations that make a difference for patients across the globe.

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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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):

Requisition ID:R243364