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Manufacturing Tech II - Billerica, United States - Lantheus
Description
Lantheus is headquartered in Bedford, Massachusetts with offices in New Jersey, Canada, and Sweden.
For more than 60 years, Lantheus has been instrumental in pioneering the field of medical imaging and has helped physicians enhance patient care with its broad product portfolio.
Lantheus is an entrepreneurial, agile, growing organization that provides innovative diagnostics, targeted therapeutics, and artificial intelligence (AI) solutions that empower clinicians to find, fight and follow disease.
At Lantheus our purpose and values guide our behaviors in all interactions and play a vital role in creating a dynamic environment that contributes to our success.
Every employee is crucial to our success; we respect one another and act as one knowing that someone's health is in our hands.
We believe in helping people be their best and are seeking to bring together a diverse group of individuals with different viewpoints and skill sets to be a part of a productive and inclusive team.
The objective of this position is to perform manufacturing operations required to produce pharmaceutical products in a timely manner compliant with cGMP, OSHA, and other regulatory requirements.
Under the direction of the manufacturing manager and on-the-floor guidance of the team lead, the manufacturing technician II will become qualified and independently capable of performing all aspects of internal cold manufacturing operations.
Such operations include, but are not limited to, receipt and transfer of materials and components into the manufacturing unit operation, component and equipment cleaning and preparation, operation of automated manufacturing equipment with good aseptic technique, completion of production transactions within the ERP system, completion of paper-based production records and forms in accordance with GDP.
Equipment utilized by the manufacturing technician II includes parts washers, sterilizers, tanks and vessels, single-use assemblies, filter integrity testers, automated filling equipment, inspection and packaging equipment.
Performs the material transfer, preparation, batching, filling, inspection and ancillary operations associated with the manufacture of pharmaceutical products.
Demonstrates ability and willingness to receive direction and coaching from team lead and manager
Able to work effectively and re-prioritize work activities in a dynamic manufacturing environment
Enters, checks and reviews data for accuracy and completeness, independently.
Interacts positively with team members to coordinate functions and maximize efficiency.
Resolves routine manufacturing problems independently or by utilizing the appropriate technical group resource and problem solving techniques.
Utilizes knowledge, experience, and group resources to make decisions regarding routine issues.
Communicates effectively across departments.
Communicates effectively in situations involving pressure.
Demonstrates an understanding and strict compliance with standard operating procedures (SOPs)
Demonstrates the ability to apply knowledge of the cGMP Regulations (Parts 210 and 211) to routine situations.
Demonstrates knowledge and fundamental understanding of operating computer-controlled automated production equipment.
Demonstrates knowledge of applicable software.
Performs numerous tasks ranging from basic to complex functions.
Performs inventory moves and material transactions within the ERP system.
Coordinates the procurement of various materials from the warehouse needed for manufacturing processes.
Directly supports efforts of other groups as part of daily responsibilities, including:
Coordination of WFI and Steam usage to support production.
Participation and support of maintenance staff while troubleshooting or making equipment repairs
Operating manufacturing equipment to support engineering studies or validation protocols
Coordination with metrology to provide calibrated devices in a timely manner
Support of capital project planning and execution, as related to impact on manufacturing operations
Coordination with microbiology and disinfection for routine and non-routine disinfection and sampling
Recommends process/quality improvements.
Recognizes and suggests personal objectives which complement and support group and organizational goals.
Influences others in meeting their group objectives through support and cooperation.
Actively promotes safety rules and awareness.
Demonstrates good safety practices at all times including the appropriate use of protective equipment.
Reports and takes initiative to correct safety & environmental hazards.
Actively demonstrates the Lantheus values of Accountability, Quality, Efficiency, Customer Service, Collaboration, and Safety.
Basic Qualifications
Associates Degree in a science related field and - 2 years of experience in a pharmaceutical/biotech manufacturing environment
High school diploma with - 5 years of experience in a pharmaceutical/biotech manufacturing or quality environment.
Working in a clean-room environment and previous experience with cGMP's is a plus.
Other Requirements
Knowledge of company product portfolio and manufacturing processes.
Exhibits a desire to learn and cross-train within the organization
Ability to work according to cGMP guidelines.
Familiarity with aseptic technique.
Practical working knowledge of computer systems and platforms.
In depth knowledge of manufacturing equipment and new technologies.
Hands-on experience with manufacturing processes and problems, including trouble-shooting, scale-up, and optimization efforts.
Typical first-shift schedule is 6:00 AM to 6:00 PM during batch production, and may vary with notice based on production needs
May include working holidays, weekends, and mandatory overtime, as needed.
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