Process/Senior Process Chemistry Engineer

Process/Senior Process Chemistry Engineer Purisys - 3.0 Athens, GA Job Details Full-time $90,000 - $120,000 a year 12 hours ago Benefits Health savings account Health insurance Dental insurance Flexible spending account Paid time off Employee assistance program Vision insurance 401(k) matching Life insurance Referral program Qualifications OSHA (regulatory compliance area) Computer operation Pharmaceutical regulatory compliance Bachelor of Science Manufacturing facility Bachelor's degree Decision making Laboratory compliance Respiratory protection Process engineering Full Job Description Purisys is a trusted CDMO partner for custom pharmaceutical API and other chemical synthesis projects with capabilities unique in the industry. Built over a 40-year history, our expertise allows us to support a diverse range of custom API development projects from proof of concept, bench chemistry to full-scale product commercialization - with particular strengths in full-service clinical Phase I/II and small volume, orphan drug commercial API GMP synthesis. Our broad ranging, and often specialized, chemistry capabilities make us the partner of choice for technically intensive and complex projects. Purisys also has an industry-leading track record in compliance with US FDA cGMPs and other global regulatory bodies. For more information on the company please visit https://purisys.com

GENERAL PURPOSE OF JOB

Primary responsibility is to plan and conduct activities related to the implementation of processes into the small scale production facility. This person would provide engineering expertise and technical leadership for the SSPF in support of custom synthesis and technical transfer projects. This includes collaboration with R D, researching technologies/equipment, evaluating process cost/quality/capability alternatives, and using new or established methodology and engineering solutions where required. Provide technical leadership and act as a liaison between Process R D and SSPF for the evaluation and execution of new and existing products and processes, and evaluation of new technology applications. Additionally, this person would have direct responsibilities with executing environmental, health, and safety activities associated with storage, collection, and destruction of hazardous waste in both the laboratory and

SSPF. ESSENTIAL DUTIES AND RESPONSIBILITIES

• Full working knowledge of chemical processes, development, scale-up and manufacturing as they pertain to Purisys products and capabilities.
• Advanced knowledge of pilot/production chemical processing and equipment. Able to train others on basic synthetic/organic techniques and support equipment.
• Authors and/or assists with all necessary report and documentation in order to execute experiments in the SSPF, including standard operating procedures, batch records, cleaning records, and equipment qualification protocols and reports.
• Advanced knowledge of using laboratory equipment required to conduct synthetic experiments (such as temperature control units, vacuum pump, drying oven, rotovap, etc). Knowledgeable of basic synthetic/organic techniques (such as reflux, distillations, crystallizations, column purification, synthetic methodologies).
• Performs synthetic use tests if required as part of process familiarization or to make process improvement to improve yield, quality, and safety to support products and processes implemented in the SSPF. Conduct research by following established processes and procedures, as well as recommending and utilizing published organic methodologies where required.
• Maintains and provides notebooks, records, and documentation which are current, legible, readily understood, complete and accurate to ensure compliance with established procedures and specifications, and are verifiable.
• Working knowledge of documentation and associated systems (such as Master Control, SAP, Biovia).
• Consults and collaborates with Process R D scientists, Operations staff and Process Engineers, and management where appropriate.
• On a project-basis, may assist with the procurement, installation and calibration of laboratory or plant instruments, equipment and supplies to ensure reliable, prompt, precise and accurate data. May assist with the setup, IQ, OQ and PQ of new equipment.
• Required to assist pilot plant or production operators during introduction of new or existing processes.
• Trains new personnel in procedures/processes and equipment. May train others in new processes/technology or equipment depending on area of expertise in accordance to internal procedures and guidelines.
• Maintain RCRA (Resource, Conservation, and Recover Act) training in accordance with EPA and OSHA requirements.
• Perform weekly inspection of hazardous waste accumulation areas on site, inventory and schedule hazardous waste pickup by outside contractors, and support documentation in preparation for audits.
• Practices continuous improvement in the development of new or refined materials, processes, products and/or scientific/business procedures and processes.
• Makes decisions regarding analyzing and interpreting data, drawing conclusions, and arriving at timely technical decisions.
• Implements equipment, materials, and process performance requirements, performs vendor searches and equipment evaluation to ensure adequate capability to produce quality products in the SSPF in required quantities at an effective cost.
• Familiar with analytical methods and instrumentation.
• Participates in team efforts to resolve issues related to manufacturing control/improvement.
• Supports the development of innovative engineering solutions in support of new or existing products or processes. May be responsible for contributing to multiple projects at one time.
• Provides engineering input to on-going research and development efforts.
• Performs other appropriate duties as assigned by the Operations & Supply Chain Manager.

ADDITIONAL POSITION REQUIREMENTS

• Adheres to and promotes company standards regarding conduct, housekeeping, safety and quality
• Successfully completes regulatory and job training requirements.
• Understands and responsibly performs duties with attention to quality, safety and environmental matters.

Items include; wearing appropriate personal protective equipment, recognizing, reporting and appropriately responding to hazards in the work area (spills/accidents/near misses), maintaining proper housekeeping at all times, properly labeling and storing chemicals, plus all other relevant job requirements.

• Carries out duties in compliance with all state and federal regulations and guidelines including FDA, EPA, OSHA and DEA. Complies with all company and site policies and procedures.
• Assumes responsibility for the environmental effects of work performed and for the identification and recording of environmental problems as they arise.
• Follow all applicable aspects of the site Environmental Management System as it pertains to normal job duties.
• Remains current in skills and industry trends.
• Must be available for non-traditional hours to support SSPF and process chemistry activities on a scheduled or emergency basis.
• Complete understanding and working knowledge of computerized data acquisition, analysis and handling techniques to ensure reliable, prompt, precise and accurate test data using established methods and procedures.
• Ability to make independent decisions within general guidelines and to work under minimum supervision.
• Is available for other duties as required.

SUPERVISORY RESPONSIBILITIES

None EDUCATION and/or

EXPERIENCE

• BS in engineering, chemistry or related field and a minimum of six years related experience. (Related experience would include direct experience with kilo lab/pilot plant operation, and/or process development activities in a similarly industry.)
• Experience in chemical processing and/or pharmaceutical industry is required.
• Basic knowledge of cGMP/cGLP regulations is required.

LANGUAGE SKILLS

• Read, analyze, and interpret complex documents including business periodicals, professional journals, technical procedures, or governmental regulations.
• Read, analyze, and interpret common scientific and technical journals, financial reports, and legal documents.
• Write technical reports, business correspondence, and procedure manuals.
• Effectively present information and respond to questions of top managers, clients, customers, regulatory agencies and the general public.
• Strong technical writing skills.
• Respond to common/sensitive inquiries or complaints from customers, regulatory agencies, or members of the business community.
• Writes presentations and technical documents using original or innovative techniques or style.

MATHEMATICAL SKILLS

• Applies advanced mathematical concepts such as exponents, logarithms, quadratic equations, and permutations.
• Applies mathematical operations to such tasks as frequency distribution, determination of test reliability and validity, analysis of variance, correlation techniques, sampling theory, and factor analysis.
• Apply principles of logical or scientific thinking to a wide range of intellectual and practical problems.
• Deal with nonverbal symbolism (formulas, scientific equations, graphs, etc.

,) in highly complex phases.

REASONING ABILITY

• Defines problems, collect data, establish facts, and draw valid conclusions.
• Interprets an extensive variety of technical instructions in mathematical or diagram form and deal with several abstract and concrete variables.
• Applies principles of logical or scientific thinking to a wide range of intellectual and practical problems.
• Deals with nonverbal symbolism (formulas, scientific equations, graphs, etc.

,) in its most difficult phases.

OTHER SKILLS ABILITIES OR QUALIFICATIONS

• Hands on experience with large laboratory scale (10-50L) equipment
• Familiar with automated systems and chemical/pharmaceutical plant equipment
• Knowledge of organic chemistry and cGMP regulations
• Uses computer software and customize programs to meet business needs, including word processing and mathematical applications.
• Must be able to work with people, influencing their output and work behavior.
• Must be able to work in situations where speed and sustained attention are essential, performing a variety of tasks without loss of production.
• Must be able to manage multiple priorities on a daily basis while being flexible and responsive to frequently shifting priorities.
• Strong organizational and communication skills are essential.
• Demonstrated ability to prioritize work of self and teams (when necessary) based on customer needs and compliance requirements.
• Possesses strong leadership, conflict management and team-building skills.
• Proven ability to perform repetitive tasks while maintaining speed of work and attention to detail without loss to production.

PHYSICAL DEMANDS

• While performing the duties of this job, the employee is regularly required to stand; walk; use hands to finger, handle, or feel; climb, bend and stoop; and reach with hands and arms.
• The employee must be able to lift, push, pull and/or move up to 40 pounds.
• Specific vision abilities required by this job include close vision, distance vision, color vision, depth perception, and ability to adjust focus.
• Must be able to qualify for respiratory protective equipment use.

Purisys considers all employees and applicants for employment and prohibits discrimination and harassment of any type without regard to race, color, religion, age, sex, national origin, disability status, genetics, protected veteran status, sexual orientation, gender identity or expression, or any other characteristic protected by federal, state or local laws.

Job Type:

Full-time Pay:

$90,000.00 - $120,000.00 per year

Benefits:

401(k) matching Dental insurance Employee assistance program Flexible spending account Health insurance Health savings account Life insurance Paid time off Referral program Vision insurance

Work Location:

In person