Aseptic Manufacturing Technician I - Night Shift Contract to Hire
Aseptic Manufacturing Technician I - Night Shift Contract to Hire
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Salary Not Disclosed
1 Vacancy
Job Description
Overview
The Aseptic Manufacturing Technician I role is crucial for the autologous cell therapy manufacturing program. This position requires a broad understanding of theories techniques and principles to support manufacturing processes. As an Aseptic Manufacturing Technician I you will be responsible for various tasks such as cleaning sanitization preparation and fulfilling products for commercial and clinical use. To excel in this role the candidate strongly desires to have a background in cell culture aseptic gowning and qualification and ISO class 5 cleanroom operations.
Shifts: A or B
Shift ARotation
- Week 1
- Sunday to Tuesday: 6:00PM 6:30AM
- Sunday to Tuesday: 6:00PM 6:30AM
- Week 2
- Sunday to Wednesday : 6:00PM 5:30AM
OR
Shift BRotation
- Week 1
- Wednesday to Saturday: 6:00PM 5:30AM
- Week 2
- Thursday to Saturday: 6:00PM 6:30AM
Essential Functions and Responsibilities
- Develop a comprehensive understanding of and be able to proficiently execute Iovances GMP cell therapy manufacturing process(es).
- Complete training sessions and ensure training documentation is maintained.
- Understand and comply with quality standards and requirements as documented.
- Provide operational support functions including materials stocking and transfer kit preparation reagent preparation room readiness cleaning activities and equipment maintenance.
- Perform document review including executed Batch Records and Logbooks.
- Adhere to Good Manufacturing Practices (GMP) and Standard Operating Procedures (SOPs) including Good Documentation Practices (GDP). Completes recording of data to comply with regulatory requirements.
- Attend the daily huddle meeting and escalates issues/concerns at that forum to Area Management for further investigation.
- Ability to work in a team environment and independently as required. Works on routine assignments per written procedures where the ability to recognize deviation from accepted practice is required.
- Must adhere to Iovance Biotherapeutics core values policies procedures and business ethics.
- Comply with Safety SOPs SDS sheets and laboratory procedures per company policy and OSHA regulations.
- Perform miscellaneous duties as assigned.
Required Education Skills and Knowledge
- Bachelors degree or some postsecondary education.
- Minimum 01 years of experience in biopharmaceuticalbased GMP manufacturing operations including experience in cell culture and associated downstream processing.
- Must be able to deal with ambiguity ready to change gears and plans quickly and manage constant change.
- Must be able to read write and understand English for Good Documentation Practices
- Proficient in Microsoft (Excel Word Outlook).
- Ability to perform arithmetic calculations including fractions decimals and percentages and basic algebraic and geometric calculations accurately and reproducibly.
- Quality mindset familiar with 21 CFR Part 11 and standard GxP best practices and FDA regulations.
- Proactive resultsoriented selfstarter with experience in a complex manufacturing environment.
- Ability to build relationships quickly and credibly.
- Ability to work successfully in a fastpaced teamoriented environment.
The physical demands described here represent those that an employee must meet to perform the essential functions of this job successfully. Reasonable accommodations may be made upon request to enable individuals to perform essential functions. Please contact Human Resources to request an accommodation.
For the Visual Inspection Program the technician must be able to pass a Vision Exam that includes the following:
- Must not be color blind.
- Must have 20/20 near vision in both eyes (can be corrected)
- Clarity of vision at near and midrange depth perception and ability to identify and distinguish colors may be given a visual exam for visual acuity and color perception.
Physical Demands and Activities Required:
- Must be able to wear appropriate cleanroom attire and all Personal Protective Equipment (PPE) i.e. scrubs gowning coveralls masks gloves etc.
- Must meet requirements for and be able to wear a halfface respirator.
- Able to stand and/or walk 90 (and sit 10 within your scheduled workday which may include climbing ladders or steps.
- Able to crouch bend twist reach and perform activities with repetitive motions.
- Must be able to lift and carry objects weighing 45 pounds.
Mental:
Clear and conceptual thinking ability; excellent judgment troubleshooting problemsolving analysis and discretion; ability to handle workrelated stress; ability to handle multiple priorities simultaneously; and ability to meet deadlines.
Work Environment:
This position will work in both an office and a manufacturing lab setting. When in the lab must be able to work in a Lab setting with various chemical/biochemical exposures including latex and bleach and potential exposure to noise and equipment hazards and strong odors.
The statements contained in this document are intended to describe the general nature and level of work being performed by a colleague assigned to this description. They are not intended to constitute a comprehensive list of functions duties or local variances. Management retains the discretion to add or to change the duties of the position at any time.
Iovance is committed to cultivating and offering a diverse and inclusive work environment. As an equalopportunity employer our employees and applicants will be considered without regard to an individuals race color religion sex pregnancy national origin age physical and mental disability marital status sexual orientation gender identity gender expression genetic information military and veteran status and any other characteristic protected by applicable law. If you need assistance or accommodation to apply to one of our opportunities please contact
By voluntarily providing information and clicking Submit Application you explicitly consent to the collection and use of your personal information for the purposes described above and in ourCandidate Privacy Notice.
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Required Experience:
Senior IC
Employment Type
Contract
