Algebra, Asepsis, Calibration, Change Control, Chromatography, Cleanroom, Column Chromatography, Employee Retention, GMP (Good Manufacturing Practices), Geometry, Leadership, Lift/Move 25 Pounds, Manufacturing, Manufacturing Management, Manufacturing Operations, Mathematics, Mentoring, Polishing, Procedure Development, Standard Operating Procedures (SOP), Talent Management
South Plainfield, New Jersey
Sr. Manufacturing TechnicianIntegrated Resources, Inc., is led by a seasoned team with combined decades in the industry. We deliver strategic workforce solutions that help you manage your talent and business more efficiently and effectively. Since launching in 1996, IRI has attracted, assembled and retained key employees who are experts in their fields. This has helped us expand into new sectors and steadily grow.Job DescriptionJob SummaryThe Manufacturing Technician will report to the Supervisor of Manufacturing.The Manufacturing Technician performs or leads functions associated with Manufacturing operations, including set-up and calibration tasks, aseptic processing and sampling operations, single-use component set up and operations, buffer formulation and transfer, TFF, depth filtration, polishing and sterile grade filtration, viral removal operations, column chromatography, and final fill operations.Essential Duties and Responsibilities:Assists or leads with resolving technical issuesPromotes manufacturing best practicesPerforms and leads operations in a Single-use technology facilityExperience working in GMP manufacturingWrites routine reports, quality documents ( SOPs, batch records, deviations, change controls ), and shift exchange summariesTrains and mentors other techniciansLeads operations or projects as assigned by ManagementApplies concepts of basic algebra and geometry in everyday activitiesEducation and/or Experience:College degree and/or a minimum of 5 years of related experience required.Downstream purification experience with specific attention towards TFF at either bench scale or large scale.Experience with chromatography and buffer prep is a plusExperience with fill/finish, final fill equipment, and filling isolatorsExperience working with process automationExperience working in an aseptic or clean room environmentExperience authoring standard operating procedures, batch records and working in GMP document generation/life cycle managementSupervisory Responsibilities:This position will serve as the primary technician in support of the Manufacturing Supervisor.Management training may be assigned as part of a progression plan.Leadership responsibilities in support of or in lieu of the Manufacturing Supervisor will be assigned and/or expectedLanguage, Mathematical, and/or Reasoning Ability:Ability to read and interpret documents such as safety rules, operating and maintenance instructions, and proceduresAbility to speak effectively in a group settingAbility to present data and information slide shows in front of a groupAbility to interpret a variety of instructions provided in written, oral, diagram, or schedule formatPhysical Demands:While performing the duties of this job, the employee is required to move frequently and sit or stand as the job requiresThe employee may frequently lift and/or move up to 25 pounds and occasionally lift or move up to 50 poundsThe employee may frequently move large mobile vessels across a room or from one room to anotherMust be willing to work longer than 8 hours (or shift hours) during processingMust be flexible with scheduling and working hours to accommodate a staggering or 2nd/3rd shiftI
Integrated Resources, Inc