SUMMARY/OBJECTIVE:
Under minimal supervision, this position is responsible for operation of pharmaceutical manufacturing equipment in a GMP environment for the purpose of making clinical supplies and performing development experiments. Incumbent is also responsible for leading manufacturing activities in assigned production rooms.
ESSENTIAL DUTIES AND RESPONSIBILITIES:
- Train on, comply with, and understand all policy and procedures at Experic including Regulatory, Safety, SOPs, Work Instructions, etc.
- Assist in the development of new processes in procedures under the management direction including:
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Becoming subject matter expert for pharmaceutical manufacturing equipment.
- Adapting understanding of equipment into (write) new SOPs and work instructions and assisting in the training of additional staff on equipment specialty.
- Front line troubleshooting of processes and equipment.
- Perform Pharmaceutical Manufacturing activities including:
- Batch Documentation/Record Generation
- Materials sampling, staging, dispensing, and return
- Pharmaceutical Equipment and Room set-up, operation, and cleaning
- Use of appropriate personal safety equipment and engineering controls
- In-process inspection and sampling
- Use Experic IT Platform
- Perform developmental manufacturing experiments under the direction of management.
- Support investigational and quality systems activities.
- Assist maintenance in the performance of preventative maintenance activities, troubleshooting and repair of equipment.
- Participate in continuous improvement activities at Experic.
- Carries out duties in compliance with all federal and state regulations and guidelines.
- Complies with all company and site policies and procedures.
- Mechanical Aptitude, curiosity to explore complex machinery, and a desire to learn new processes.
- An ability to learn and remain self-directed on tasks that are both well-defined and more exploratory.
- Learn, become and remains current in profession and industry trends.
- Makes a positive contribution as demonstrated by:
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making suggestions for improvement
- learning new skills, procedures, and processes.
- Is available for other duties as required.
QUALIFICATIONS AND EXPERIENCE:
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Requires a bachelor's degree in an Engineering or Scientific Field with one (1) year of experience in Pharmaceutical or Life Science area or a High School Diploma and four (4) years of experience in pharmaceutical manufacturing with an emphasis on working on the implementation of new equipment and processes.
COMPETENCIES/SKILLS:
LANGUAGE SKILLS
- Read and interpret documents such as standard operating procedures, manuals, batch records, work instructions and specifications.
- Legible Handwriting
- Communicate clearly in writing and orally including in the creation of standard operating procedures and work instructions.
MATHEMATICAL SKILLS
- Apply concepts of basic arithmetic such as addition, subtraction, fractions, percentages, ratios, and proportions to practical solutions.
- Graph data using spreadsheets and perform simple statistical analyses (means, standard deviations, linear regression).
REASONING ABILITY
- Identify simple and moderate problems related to job function.
- Scientific Reasoning the ability to gather data based on observations and measurement, formulate hypotheses, propose experimental tests, and draw conclusions, systematically.
- Deductive Reasoning: Demonstrated experience applying general and complex rules to specific problems to produce answers that make sense.
- Inductive Reasoning: Demonstrated experience applying a logical process in which multiple premises, all believed true or found true most of the time, are combined to obtain a specific conclusion (includes finding a relationship among seemingly unrelated events).
- Knowledge of cGMP.
- Familiar with Pharmaceutical Manufacturing.
- Successfully completes regulatory and job training requirements.
Computer skills:
- Enter data into computer using software applications for data entry and word processing. Work and be proficient with e-mail systems.
- Ability to perform repetitive tasks while maintaining speed of work and attention to detail without loss to production.
- Ability to work individually in a self-directed manner with less than daily oversight.
- Ability to work with others in a team environment.
SUPERVISORY RESPONSIBILITIES:
SCHEDULE:
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Fully Onsite: 5 days in office in Cranbury, NJ.
SALARY:
WORK ENVIRONMENT:
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Office Environment (standing and sitting) requires minimal physical exertion.
PHYSICAL DEMANDS:
- While performing the duties of this job, the employee is frequently required to stand, walk, use hands to touch, handle or feel, and talk or hear.
- The employee is occasionally required to sit and reach with hands and arms.
- The employee must be able to lift and/or move up to 50 pounds is preferred.
- The employee is occasionally required to sit; climb or balance; and stoop, kneel, crouch or crawl.
- Specific vision abilities required by this job include close vision, distance vision, color vision, peripheral
- vision, depth perception and ability to adjust focus.
TRAVEL:
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Less than 5% of the time.
The job demands described here are representative of those that must be met by an employee to successfully perform the functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions. This job description is not intended and should not be construed to be an exhaustive list of all responsibilities, skills, efforts, or working conditions associated with the job. It is intended to be a reflection of those principal job elements essential for recruitment and selection, for making fair job evaluations and for establishing performance standards. The percentage of time spent performing the various job duties is not absolute. The incumbent shall perform all other functions and/or be cross trained as shall be determined by the sole discretion of management, who has the right to amend, modify, or terminate this job in part or in whole. This document is not a contract for employment.
EXPERIC is an Equal Opportunity Employer and all qualified applicants will receive consideration for employment without regard to race, color, religion, sex, national origin, disability status, protected
