Off-shift Sterile and Packaging Operations Formulator | Level 1

Job Description

New hires based in the US & Puerto Rico will be required to demonstrate that they have been fully vaccinated for COVID-19 or qualify for a medical or religious exemption or accommodation to this vaccination requirement, subject to applicable law.

Are you looking for an exciting opportunity with a rapidly growing pharmaceutical manufacturer? If so, then this is the opportunity for you!

Our Manufacturing Operations teams are the people that make our products. We work in the manufacturing plants with a “Safety First, Quality Always” mindset striving for continuous improvement. We work in the local plant connected to our global manufacturing network to ensure the highest quality of raw materials, intermediates and finished products.

Under the direction of a supervisor, the Sterile and Packaging Operations Formulator | Level 1 initiates and completes a wide variety of tasks and operations in GMP, aseptic and controlled environments that are required to support and implement 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, and completing associated batch record and logbook documentation. Performs preventative maintenance, set-up, troubleshooting and repairs as assigned for the equipment and facilities within Sterile and Packaging Operations. Uses computer systems to operate equipment where necessary. Performs cleaning and housekeeping requirements as assigned in the areas. Participates in continuous improvement activities and collaborates across other areas as necessary to ensure business needs are met.

Serves in a leadership role to coordinate and execute line/equipment set-up, start-up, and on-going operations on a daily basis. Assists in developing and delivering training for new employees. Provides real-time status of the operation 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.

Ability to instruct and train other employees, mechanical aptitude, 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. 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.

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, cleaning equipment, sterilization equipment, process equipment, and material handling equipment

• PPE and safety equipment for processing of PBECL Level 3 compounds

• Personal computers, network terminals, and computer interfaces

• Processing tools and simple maintenance tools not requiring certification/training that are used in SPO

Additional Responsibilities

• Assists in the scheduling and coordination of the activities of the department operators | Planning and coordination of overtime selection and tracking

• Manufactures and documents in compliance with cGMP’s vaccine intermediates by adding, mixing, and dissolving ingredients in the prescribed sequence as per the appropriate Manufacturing Process Description, Standard Operating Procedures, and interactions with the Distributed Control System automation

• Conducts 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

• Formulates culture media preparations to proper ratios as per the appropriate Manufacturing Process Description and Standard Operating Procedures and documents in compliance with cGMP’s

• Prepares filters and filter assemblies for sterilization in Department 173 ensuring the sterility dating of all process equipment

• Initiates and completes sterile filtration of culture media products and pharmaceutical solutions attaining critical final filtration volumes

• Completes all necessary process calculations | process verification steps

• Compares the values to acceptable limits as defined by the process description or applicable SOP

• Notifies supervisor immediately if results are outside of the acceptable limits

• Understands and interfaces with the automation programs, computer systems/databases used in manufacturing

• Completes timely SAP transactions

• Checks pH of in-process batches and makes critical pH adjustments using titration principles to obtain the final product pH as specified in the appropriate process description

• Sets-up process equipment, makes piping connections, and opens and closes process vessels by mechanical methods using the necessary wrenches, tri-clover clamps, quick disconnects, or other tools

• Initiates and completes filter bubble point integrity testing per approved SOP using manual techniques or automatic filter integrity test equipment | Sterile welding per approved SOP using the Terumo sterile welders

• Uses validated manual washing procedure per approved SOP to clean miscellaneous equipment/glassware

• Initiates and completes pressure tests of portable stainless steel tanks used in the manufacture of live virus stabilizers and alum based products | Retorquing of true-union bottles used in the manufacture of live virus stabilizers per approved SOP | All necessary per process scale checks per approved SOP to confirm operation prior to use

• Transports final bulks to proper staging or holding areas and ensures product is blanketed with sterile nitrogen when applicable

• Checks incoming raw materials for dating, usage, potency, weight, and physical appearance

• Immediately informs supervisor of any deviations or discrepancies prior to using the materials in manufacturing activities

• Receives chemicals, biological bulks, and culture media products for manufacturing and stages them in the Department 113 storeroom or cold vaults

• Maintains organization of the Department storeroom and cold vaults and logs material in and out of the cold vaults per approved SOP’s

• Coordinates activities required to manage inventory of supplies, components, and equipment to meet production schedules

• Inventories necessary stock equipment, glassware, filters, chemicals, etc. required for continuous operation of the department. Ensures materials are organized, stored, segregated, and staged for production operations

• Palletizes, shrink-wraps, or otherwise prepares all items related to manufacturing to be shipped to other buildings

• Appropriately labels and stages these items on the Building 29 loading dock for shipment

• Following completion of a manufacturing operation, performs all necessary housekeeping activities in preparation for the next manufacturing operation

• Cleans/polishes/disinfects and otherwise maintains the cleanliness and appearance of all manufacturing equipment and work surfaces in the Department 113 production area

• Completes daily department water flushes | Checks the chemical levels in the CIP drums and changes the drums | Weekly sanitizations of Tank 201 | SIP and water intrusion integrity testing of sterile air filters

• Changes in-line process filters as required per SOP | Selects the proper filters and verifies the certificate of analysis prior to installation

• Supports experimental work, such as new product scale up efforts, technical investigations, and new product engineering batches | Manufacturing of all new product validation lots by working closely with our Company Research Laboratories, Process Engineering, and Process Validation personnel

• Assists Validation Engineers by completing job duties in support of continuing validation activities and any other validation activities in the department

• Manufactures PB-ECL class 3 compounds such as Cancidas, properly utilizing all necessary process safety equipment and personal protective equipment

• Completes thawing of frozen live virus bulks as per approved procedures | Coordinates mechanical requests to ensure proper running and maintenance of all processing equipment

• Completes cleaning including CIP and SIP of tanks, as well as manual washing of equipment

• Maintains and controls inventory of processing equipment, components, spare parts, stockroom items and tools

• Sets up, changes over, and test runs equipment as required | Makes mechanical adjustments necessary for the correct operation of the equipment

• Completes all required log sheets, batch records training rosters and other documentation as required, with adherence to Right First Time (RFT) | Completes end of shift production document review and returns completed documents to a supervisor or to the appropriate designated location in the supervisor’s office

• Conducts routine microbial, particulate and WFI sampling for environmental monitoring

• Makes periodic checks of containers/components to determine satisfactory operation of equipment

• Responsible for taking samples for Release, in-Process, or Validation

• Assists in developing and delivering training for new employees | 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

Education

• High School Diploma or equivalent

Experience and Skills

Required

• Three years (within the last seven years) in aseptic bulk product formulation or aseptic processing which involves making sterile connections, following the sequence in a Manufacturing Process Description and completing cGMP documentation

• In lieu of above experience, three years (within the last seven years) of bulk production formulation, i.e. manufacturing of products using process descriptions, sample measurement, and in-process additions

• Attend aseptic techniques training followed by successful completion of the aseptic skills qualification testing program within the probationary period

• Successfully demonstrate and maintain proficiency in aseptic techniques and aseptic gowning

Work Environment Conditions

• 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 compounds

• Adhere to PPE (i.e. RACAL air-purifying helmet) and gowning requirements at all times

Our Manufacturing & Supply Division is dedicated to being the most trusted supplier of biopharmaceuticals worldwide. Our facilities, along with our external contractors, suppliers, and partners, create a reliable global manufacturing network that’s devoted to delivering a high-quality, reliable supply to customers and patients on time, every time.

Who we are …

We are known as Merck & Co., Inc., Kenilworth, New Jersey, USA in the United States and Canada and MSD everywhere else. For more than a century, we have been inventing for life, bringing forward medicines and vaccines for many of the world's most challenging diseases. Today, our company continues to be at the forefront of research to deliver innovative health solutions and advance the prevention and treatment of diseases that threaten people and animals around the world.

What we look for …

Imagine getting up in the morning for a job as important as helping to save and improve lives around the world. Here, you have that opportunity. You can put your empathy, creativity, digital mastery, or scientific genius to work in collaboration with a diverse group of colleagues who pursue and bring hope to countless people who are battling some of the most challenging diseases of our time. Our team is constantly evolving, so if you are among the intellectually curious, join us—and start making your impact today.

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.

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 Poster

EEOC GINA Supplement​

OFCCP EEO 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.

Search Firm Representatives Please Read Carefully
Merck & Co., Inc., Kenilworth, NJ, USA, also known as Merck Sharp & Dohme Corp., Kenilworth, 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):

Number of Openings:

Requisition ID:R156884