Duration: 12 months- potential to convert into full time
The position is responsible for supporting the research and development of diagnostic medical devices. Must be able to independently setup and operate machinery for various product development processes. Must conduct product development activities in laboratory as well contribute to scale-up activities. Independently capture the generated data in a scientific format. Must maintain laboratory product development equipment, inventory management, associated facilities and machinery under strict compliance to applicable GLP, GMP, DEA, state and local regulations.
Setup, operate, disassemble, and clean any equipment for unit operations for product without supervision.
Clean workspace after completion of operation.
Perform daily other duties as assigned or requested in assigned work areas within defined time.
Visually inspect the equipment during run to verify the equipment is running within a normal and safe operation.
Maintain equipment parts and supplies in proper condition.
Interact with maintenance and vendors when required to maintain, upgrade, or purchase equipment.
Calibrates equipment per procedures.
Ensures equipment are operated and cleaned properly in accordance with company SOPs.
Manufacture PD experimental batches, according to MBR provided by Scientist, following all required SOPs within defined time.
Conduct, in-process sampling and physical testing of experimental batches.
Record in process data during product manufacturing and document in Batch Record
Perform reconciliation of raw material, and finished product for batch processing; such as determining loss amounts, process yields and accountability and verifying inventory reconciliations according to regulatory requirements and company SOP's for experimental batches.
Document setup, use, and cleaning in appropriate logbooks
Maintain raw materials and supplies according to department procedures
Utilize SAP system to place orders
Modify and update SOPs
2-5 years pharmaceutical experience
Have strong oral and written communication skills, as well as basic computer skills with Microsoft Word, Excel and Outlook
Ability to lift equipment or materials weighing up to 50-70 pounds.
Recognizes product characteristics and problems to watch for.
Strong process/equipment knowledge for some major equipment and demonstrated ability to learn new unit operations.
Setup, operate, disassemble, clean and maintain all equipment involved in formulation and pre-formulation/physical characterization of product.
Perform basic mathematical calculations including addition, subtraction, multiplication, and division. Convert units between metric and English and vice versa.
Follow company policies, cGMP’s, DEA regulations, and SOP’s.
Wears appropriate personal protective equipment and follows all safety regulations and procedures.
Ensures project deadlines and performance standards are established and met.
Working independently as well as in a group requiring minimal guidance of a scientist and/or senior technician.
A self-starter who is able to work independently with minimal direction, and who’s confident enough to ask when clarification is needed.
Proven team player with strong interpersonal skills.
Flexibility to adapt to rapidly changing priorities and workloads. Must be flexible and enjoy new challenges.
An unrelenting attention to detail.
* Performs quantitative and qualitative analysis, such as sampling, testing, and measuring using specialized equipment.* Completes the compiling, analyzing, and interpreting of results.* Performs periodic equipment inspections and preventative maintenance work. * Troubleshoots test processes. * Calculates as well as prepares graphs and charts.* Prepares measurement and test equipment (e.g. instrumentation and functionality tests). In Administration / (Technical) Customer Services: Incumbent is expected to cope - due to experience - with multiple choice situations in number of processes and routines. Thinking is about applying / adapting the "right" procedure to a process or an issue arising. Unexpected situations need effective solution.In Production: Operates with a range of machines and equipment, which effectively need different parameter setting and intensive control of production process. May include automated line production control in relatively medium complex environment. Or: operates in the set-up, maintenance, repair and/or installation of dedicated machines in the production line.In Assembly: Contributes to fairly complex, however routine and repetetive assembly processes, where a team of differently qualified specialitsts is involved. Assembly process for one item may take hours or even more then one day to complete. System or product might be customized, designed for specific needs. "Vocationally trained Operator / Administrator": Deliver full range service in a defined and focused technical or administrative area of work, while clear input / output relations and generic and /or work specific guidelines, procedures are given or available. Positions need basic level of theoretical and practical know how, skills and typically some level related years of experience, in specialized processes, techniques and systems used in office, production or lab environment. In Administration / Customer Services: Position operates major parts or full spectrum of dedicated specialized standard software packages. Incumbents may handle routine and non-complex practical enquiries and procedures from internal or external customers.In Technical Customer Services: Service group employee, serving internal and external customer with technical or administrative standardized services and processes, to complete or add the delivery according to service level agreed. In Production: Automated line processing and controlling, or operating with a broader range of production machines in production lines are examples for this level or work.Typical positions: Mechanic Technology Operator, Floor Assembly Operator, Administrative Functional Support 3 year vocational training + 3 years practical experience needed Basic knowledge and experience of principles, procedures, work routines and skills in the related field of work, gained through structured and focused 3-year vocational training period.