Sterile Operator Jobs (NOW HIRING)

A contract development and manufacturing organization that specializes in producing topical, semi-solid, and liquid pharmaceutical products for both prescription and over-the-counter markets. It supports clients through formulation, scale-up, manufacturing, and packaging, with a strong focus on quality, regulatory compliance, and speed to market.
OVERVIEW
The Sterile Injectable Operator is responsible for performing routine and complex processes related to
sterile injectable manufacturing, including bulk formulation, sterile filtration, aseptic filling of vials,
syringes, and cartridges, equipment sterilization (VHP and autoclave), parts washing, and cleanroom
facility maintenance. The operator will support process simulations (media fills), validation activities, and
ongoing commercial manufacturing operations on the Groninger sterile fill/finish line. 100% onsite
position at 30 N. Jefferson Rd, Whippany, NJ
ESSENTIAL FUNCTIONS
* Reports to Sterile Injectable Manufacturing Manager.
* Comprehends and adheres to all pertinent Health and Safety Regulations, Policies and Procedures.
* Comprehends and adheres to all cGMP requirements and applicable regulatory standards (FDA,
DEA where applicable).
* Follows all related SOPs, Batch Records, and Protocols accurately and without deviation from
approved procedures.
* Utilizes all approved and issued Personal Protective Equipment (PPE), including PAPR as required.
* Completes all required training activities and maintains training records in a current state.
* Clearly and accurately completes all required GMP documentation, logbook entries, and batch
records.
* Perform Room and Equipment inspections and completes all pertinent documentation.
* Prepares and compounds sterile injectable drug product formulations in accordance with
approved batch records and SOPs.
* Operates compounding vessels, mixing equipment, and associated utilities (WFI systems, nitrogen
purging) for solution preparation.
* Performs in-process testing and sampling during formulation activities (pH, conductivity, visual
inspection).
* Executes bioburden reduction steps and pre-filtration procedures prior to sterile filtration.
* Sets up and operates sterile filtration and performs filter integrity testing.
* Manages aseptic connections and transfers in Grade A/ISO 5 and Grade B/ISO 7 environments.
* Sets up, operates, and performs changeovers on the automated filling line for vials, syringes, and
cartridges. This includes operation of the VHP generators for isolator and equipment bio
decontamination cycles.
* Executes aseptic interventions and line adjustments while maintaining aseptic technique within
the isolator environment.
* Participates in process simulations (media fills / APS) as a qualified aseptic operator.
* Manages container handling, stoppering, capping, and labeling processes in accordance with
approved procedures.
* Operates automated parts washers for cleaning of product-contact and non-product-contact
equipment components. Operates autoclave for sterilization of product-contact materials.
* Supports Environmental Monitoring (EM) program by performing surface and air sampling
activities.
* Working inside cleanroom suites for several hours at a time.
* Technical comprehension of mechanical functions and controls for compounding equipment,
filling equipment, and isolator.
* Maintains and understands sterile manufacturing principles.
* Understand the process flow and step by step requirements for manufacturing.
* Cleaning equipment and facilities including Class A, B, C and D clean rooms per approved
procedures
* Assist in the execution of equipment/process qualification, validation, and protocols.
* Accurately complete batch record documentation, all appropriate logbook entries, and GMP
documentation
* Maintains equipment, change parts, and supplies inventories by checking stock to determine
inventory level; anticipating needed equipment, parts, and supplies.
* May be required to work either day or evening shifts as needed
* Qualified for work in the aseptic processing areas via gown certification.
Salary Range $35.00 - $38.00
POSITION QUALIFICATIONS
* May be required to move materials weighing up to 40 lbs
* Maybe required to wear personal protective equipment including a PAPR
* Maybe required to move about the facility
* May be required to remain in an upright position for extended periods of time
* Manual Dexterity is required.
EDUCATION:
1. High School Diploma or equivalent.
2. Computer literacy and solid communication skills (in English) are a must.
3. Must demonstrate Basic Math skills.
EXPERIENCE:
1. 10+ years working in pharmaceutical manufacturing environment, 5+ years working in sterile
manufacturing
2. Sterile injectable understanding of cGMP practices and concepts.
3. Mechanically inclined candidates are preferred.
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