LSNE Contract Manufacturing is currently seeking a Manufacturing Technician IV (Lead) to join our team!
About:
LSNE is a contract manufacturing organization with three manufacturing facilities located in Bedford and Manchester, NH. LSNE provides lyophilization services to the pharmaceutical, biotechnology, and medical device industries.
Job Summary:
This position is responsible for performing a variety of complex tasks under the general guidance and in accordance with the manufacturing instruction set and current GMP/ISO requirements and standards. With general supervision, the individual will perform routine and critical manufacturing operations, including but not limited to work functions in the aseptic and non-aseptic filling, equipment prep, cleaning dissolution, and formulation activities. Will be required to train and lead in this role.
Responsibilities:
- 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 the effectiveness and help identify training needs
- Assess staff skillsets and provide feedback to supervisors. 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 the 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
Qualifications:
- High school diploma required
- 5+ years of professional and FDA Regulated industries experience
- 3+ years of Pharmaceutical or Medical Device experience in the lead role required
- 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
Physical Requirements:
- 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.
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Job Type: Full-time
Experience:
- professional and FDA regulated industries: 5 years (Required)
- reviewing and creating controlled documents: 1 year (Preferred)
- Pharmaceutical or Medical Device - In a Lead Role: 3 years (Required)
- formulation, filing, primary packaging, and aseptic processing: 1 year (Required)
Education:
- High school or equivalent (Required)
Shifts:
- Evening (Preferred)
- Overnight (Preferred)
- Mid-Day (Preferred)
Job distance:
- Bedford, NH 03110: Between 31 and 40 miles (Preferred)
Working Days:
- Monday (Preferred)
- Tuesday (Preferred)
- Wednesday (Preferred)
- Thursday (Preferred)
- Friday (Preferred)
- Saturday (Preferred)
- Sunday (Preferred)