Manufacturing Technician IV (Lead) - Wed - Sat 3:30 pm - 2:00 am
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This position is responsible for performing a variety of complex tasks under general guidance and in accordance with the manufacturing instruction set and current GMP/ISO requirement and standards. With general supervision the individual will perform routine and critical manufacturing operations, including but not limited to work functions in aseptic and non-aseptic filling, equipment prep, cleaning dissolution and formulation activities. Will be required to train and lead in this role.
+ Maintain and adhere to safe work habits and all applicable LSNE safety procedures and guidelines
+ Execute manufacturing instructions in order to perform equipment preparation, compounding, filtration, formulation and fill activities for aseptic and terminally sterilized products in accordance with SOPs
+ Strong adherence to verbal instructions and written procedures in operating production equipment and performing processing steps; accurately completes all appropriate production documentation
+ Identifies, escalates and documents events that deviate from normal operation; participate as needed in investigations. Assist in the introduction of manufacturing schemes into the GMP manufacturing facility
+ Assist with the formulation and validation of new processes with the assistance of the tech transfer group
+ Communicate/ coordinate days scheduling and staffing plan with supervisor
+ Oversight and execution of all routine and critical operations as well as commissioning and validation activities, as assigned. Revise and author Standard Operating Procedures/Batch Records
+ Ensure documentation is complete, reviewed and meets good documentation practices (forms, logbooks, form preps, batch records, etc.). Ensure sanitization and sterilization practices (build, clean, sanitize and sterilize equipment and components to support production operations
+ Responsible for floor inventory and communicating schedule changes as needed to supervisor
+ Recommend/Implement process changes/improvements or safety/ergonomic improvements
+ Provide timely feedback on staff's performance and address minor personnel issues in a timely manner
+ Ensure staff compliance with all relevant SOPs, BR, and safety guidelines
+ Perform room sanitization activities in order to maintain controlled environment conditions
+ Conduct training and assess effectiveness and help identify training needs
+ Assess staff skillsets and provide feedback to Supervisor. Assist in developing training material and provide training to operators. Act as a role model (Lead by Example) and a resource/SME for staff
+ Initiate deviations or investigations of various complexities and work with cross-functional departments to identify root cause and implement appropriate corrective actions
+ Assist supervisor/engineer/facilities with investigations and communicate any quality issues/concerns to Supervisor and QA. Interacts with cross functional support teams, such as Quality Assurance, Quality Control, Engineering, R&D, Validation, etc.
+ Ensure general knowledge of aseptic techniques and maintain certification for aseptic gowning and demonstrate the ability to perform duties utilizing proper aseptic technique
+ Perform and ensure COP, CIP, and SIP operations are performed to prepare equipment
EDUCATION, PROFESSIONAL SKILLS, & EXPERIENCE
+ High School Diploma; Minimum 5 years professional and FDA Regulated industries experience; Pharmaceutical or Medical Device experience with 3 years in lead role
+ Associates Degree in Life Sciences/Engineering field with a minimum of 5 years of GMP Manufacturing Pharmaceutical or Medical Device Experience
+ Biotech Certificate or Associates degree with 5 years of experience in a cGXP/ISO environment, or Bachelor's degree in a scientific discipline, Biology, Chemistry, or Biotechnology with 3 -5 years of experience in a lead role preferred
+ Familiarity with formulation, filling and primary packaging and aseptic processing
+ Strong knowledge of aseptic techniques preferred
+ Flexible individual with good written and verbal communication skills
+ Excellent communication and organizational skills
+ Experience in reviewing and creating controlled documents.
+ MS Office/Excel tools experience
+ Self-motivated individual with the ability to complete and manage multiple floor activities in an effective and compliant manner. In the absence of the supervisor, they are the person of authority
+ Attention to detail with strong mechanical aptitude
+ Positive attitude and strong interpersonal skills
+ Read, write and verbally communicate in English
+ Strong ability to plan and prioritize complex activities
+ Strong analytical skills to identify risks and prepare balanced decisions
+ Ability to wear personal protective equipment such as safety glasses/goggles, gloves and safety shoes
+ Ability to gown and gain entry to controlled manufacturing areas
+ Ability to lift, pull or push equipment requiring up to 25-50 lbs. of force
+ Ability to stand for 6 hours in a production suite
+ Ability to work a 10 hour split shift and one weekend day, including holidays as scheduled
COMMUNICATIONS & CONTACTS
+ Interacts with cross functional support teams, such as QA, QC, Engineering, R&D, Validation, etc.
MANAGERIAL & SUPERVISORY RESPONSIBILITIESNot Applicable
The above statements are intended to describe the general nature and level of work being performed by people assigned to this classification. They are not intended to be construed as an exhaustive list of all responsibilities, duties and skills required of personnel so classified.
We are a fast growing, dynamic contract manufacturing privately held company specializing in process development, lyophilization and fill/finish located right in Southern NH.
We are always on the lookout for outstanding individuals, recent graduates, talented professionals, and experienced leaders with a strong work ethic, creative spirit and positive attitude.
We offer a competitive compensation and benefits package and a very generous paid time off benefit. Join our team!