Careers

Attwill Medical is seeking an experienced Maintenance Specialist to join our growing team.

• Under the direction of the Manager, Engineering and Maintenance administer departmental document control for Engineering, Maintenance and Metrology data and files.
• Assist in the calibration of plant instrumentation and equipment and administer documentation of calibration records.
• Coordinate the preventive maintenance program including scheduling, documentation and execution.
• Maintain equipment logs / files.
• Execute validation, re-validation and periodic certification of production equipment
• Act as subject matter expert for Lyophilizer operation.
• Coordinate, track and document purchase of maintenance supplies and materials.
• Organize and maintain spare parts / maintenance supply inventory
• Coordinate work order system including schedule, follow-up and documentation
• Perform mechanic duties as required and directed by the Manager, Engineering and Maintenance
• Perform other duties as directed and required.

Qualifications:

To perform this job successfully, an individual must be able to perform each essential duty satisfactorily. The requirements listed below are representative of the knowledge, skill, and/or ability required. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.

Education/Experience:

• High school diploma or equivalent.
• Licensed Refrigeration required.
• Demonstrated working knowledge of all mechanical systems
• Prior experience in a medical device, pharmaceutical or FDA regulated facility.
• Demonstrated knowledge and mastery of FDA regulations, job responsibilities/duties and understanding of the company standards.

Computer Skills:

• To perform this job successfully, the individual should have a working knowledge and proficiency of the following computer software programs:
• Microsoft Word
• Microsoft Excel
• Applicable quality, documentation and validation software
• Applicable maintenance management software

Equipment:

To perform this job successfully, the individual should be able to use the following equipment.

• Tools and equipment required to perform mechanical responsibilities
• Scales, thermometers and other digital and analog measuring equipment
• All production equipment
• All facilities equipment including HVAC, electrical, refrigeration, vacuum and pressure equipment, etc.

Attwill Medical Solutions is seeking experienced Operations Technician’s to join our growing organization. Operations Technician’s are responsible for performing standard operating procedures (SOP’s) to customer product specifications. Relies on instructions and pre-established guidelines to perform the functions of the job.

Role and Responsibilities:

• Receive and store product and packaging materials as directed;
• Set up production suites and equipment in accordance written procedures and company standards;
• Perform formulation, packaging and inspection operations in accordance with written procedures;
• Operate packaging equipment in accordance with written procedures;
• Inspect materials and products and report flaws immediately to management;
• Detect and report machine malfunctions promptly to management;
• Maintain an adequate supply of operating materials for production and obtain additional materials according to procedures;
• Document production activities on supplied forms;
• Adhere to established company policies and procedures paying special attention to safety regulations and FDA / cGMP standards;
• Wear personal protective equipment and clothing in accordance with established procedures and training guidelines;
• Conduct cleaning and sanitation operations as described in established procedures. Maintain a neat and orderly workplace at all time;
• Prepare orders for shipment according to written shipping orders and established procedures;
• Perform other related duties as assigned.

Qualifications:

• 1-3 years of experience in a manufacturing environment with High school diploma or GED;
• Has knowledge of commonly-used concepts, practices, and procedures within a typical Manufacturing / Operations environment;
• Ability to read & interpret standard operating procedures;
• Ability to push, pull, bend, stoop and stand for long periods of time;
• Ability to lift up to 30 pounds.

The Quality Technician is responsible for assisting with quality control functions that ensure products and processes conform to specification, regulatory requirements and customer expectations.

• Perform documentation review of production batch records with direction from the Quality Specialist and Quality Management
• Provide administrative assistance for the Quality Management System.
• Perform documentation review of production batch records. This includes identifying all non-conformances within the data and performing deviations, investigations, discrepancies, quality notes and root cause analysis in order to amend/document the issues.
• Perform room and equipment cleaning inspection and release for processing.
• Perform and document the inspection, sampling, preparing retains, testing, and release of raw materials.
• Perform QC lab testing, including Aw and LOD.
• Perform periodic checks on quality control equipment, measuring and test equipment according to standard operating procedures.
• Perform inspection of in-process and finished goods (FG-0398).
• Count and issue labeling materials as part of batch issue when requested.
• Set up and print labels.
• Process, review, close, and scan QMS records (e.g. CAPA, Complaints, documents…).
• Perform regularly scheduled QC tasks such as environmental monitoring testing, particle count and water testing.
• Performs other duties as assigned by management.

Qualifications and Skills:

• AS degree and 2 years of related experience and/or training or equivalent combination of education and experience.
• Prior experience in a medical device, pharmaceutical or FDA regulated facility. Demonstrated knowledge and mastery of job responsibilities/duties and understanding of the company standards.

The R&D Technician supports test initiatives related to New Product Development, Advanced Operations, and/or Sustaining Engineering.

Role and Responsibilities:

• Conducts activities, tasks, and documentation per quality system requirements
• Maintains organization of work areas, including equipment, materials, test samples and documentation
• Trains Production/QC personnel and other personnel as needed on test methods or production processes
• Assists in the development, drafting and/or revising technical documents (e.g. test methods, procedures)
• Assists in the execution of test protocols and bench testing
• Performs tests using a variety of lab equipment and tools
• Provides recommendations for improvement regarding test methods, test fixtures and production processes
• Assists in transfer of processes to Production
• Complies with company policies and procedures
• Other duties as assigned.

Qualifications:

• High school diploma or equivalent with 1-2 years of relevant experience
• Knowledge of GDP (Good Documentation Practices) and GLP (Good Lab Practices)
• Ability to work in a fast paced, collaborative team environment
• Ability to train Production/QC/technicians
• Ability to work independent of routine supervision
• Ability to use personal computers including software such as: Word, PowerPoint, and Excel
• Self-starter and highly motivated
• Excellent written, verbal, computer, and interpersonal communication skills

The R&D Manager role is responsible for designing, developing and implementing various processes and projects for new products into production for diagnostic kits and reagents, including lyosphere bead making.

Role and Responsibilities:

• Assists in development of production systems and lyophilization processes for customers for new medical device platforms complying with design control process including applicable FDA and ISO requirements;
• Develops, writes and executes test methods;
• Train manufacturing/QC personnel as needed on test methods or manufacturing processes;
• Generate formal test protocols and reports;
• Execute test protocols and conduct bench testing. Document test results per GDP, ISO and FDA requirements;
• Coordinate and oversee test sample builds. Assist with test sample builds as required;
• Design and fabricate test fixtures, tooling and equipment, including automation systems for high speed lyosphere production;
• Work with purchasing department to specify and procure capital equipment;
• Serves as a cross function team member for various project related activities;
• Lead technology transfer from Development to Manufacturing;
• Assist or lead process improvement projects to reduce costs;
• Complies with company policies and procedures;
• Maintains project schedule and delivers projects on time;
• Focuses on delivering products to support the R&D project pipeline;
• Completed year end performance reviews for team members;
• Ensure that program objectives are determined and met, logistics are effectively coordinated and budgets are adhered to;
• Actively searches for best-in-class technologies among competitors and develops innovation roadmap;
• Supports R&D projects at group level participating in meetings and sharing technical information and “best-practices”;
• Maximizes product profitability and improve product performances.

Qualifications:

• Degree in technical field (science, math, engineering or other related degree) with minimum 5 years related technical and program management experience;
• Ability to work in a fast paced, collaborative team environment;
• Strong team and Program management capabilities;
• Ability to manage multiple programs;
• Ability to coordinate test sample builds;
• Ability to write technical documents (procedures, test methods, protocols and reports);
• Ability to execute protocols and conduct data analysis;
• Ability to train manufacturing/QC/technicians;
• Ability to work with little supervision;
• Ability to use personal computers including software such as: Word, PowerPoint, Excel, and analytical software;
• Self-starter and highly motivated;
• Ability to have fun by motivating and encouraging other team members.