Process Development Technician Jobs Vacancy in Recro Pharma Gainesville
Recro Pharma Gainesville urgently required following position for Process Development Technician. Please read this job advertisement carefully before apply. There are some qualifications, experience and skills requirement that the employers require. Does your career history fit these requirements? Ensure you understand the role you are applying for and that it is suited to your skills and qualifications.
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Process Development Technician Jobs Vacancy in Recro Pharma Gainesville Jobs Details:
Pr imary Objective of Position
The Process Development Technician II operates process development (PD) equipment and is responsible for manufacturing of research and clinical products, cleanliness and routine monitoring of PD suite and equipment, and conducting inventory of PD materials and supplies. Assists in writing standard operating procedures, protocols, batch records and development reports. All functions of this position must be performed in accordance with regulatory requirements (cGMP, DEA, SOPs, etc).
M ajor Duties/Responsibilities
Weighing, dispensing and keeping manual inventory of raw and in-process materials and finished product.
Setting up, operating and cleaning equipment in Product Development such as Wurster fluid-bed processors, rotor granulators, tablet presses, Fitzmills, V-blenders, hard gelatin encapsulation machines, or capsule checkweighers.
Perform sampling and physical testing of research in-process materials, e.g. sieve analysis, particle size analysis, loss-on-drying, microscopy, etc.
Completing written documentation of work performed such as logbook entries, batch records, and material tracking forms.
Maintaining cleanliness of PD suite including mopping, disposing of garbage and general housekeeping duties.
Conducting physical inventories for controlled/non-controlled substances.
Routine monitoring of facilities and equipment, such as magnehelic gauges, water systems and stability chambers.
Assist in execution of IOQs for processing equipment.
Assist in training manufacturing operators for new product transfers.
Attend cGMP training sessions and comply with site-wide and departmental procedures including but not limited to change control, documentation, deviation reporting, cGMP compliance, safety and electronic data security. M i nimum Job Qualifications
E ducation: High School Diploma or General Education Degree (GED) required. Associates degree or technical training related to operation of equipment is highly preferred.
E xperience: At least 5 years’ experience in related pharmaceutical manufacturing work, including at least 2 years’ experience in solid oral dosage pharmaceutical manufacturing work.
Working knowledge of cGMP regulations and safety procedures, Microsoft Windows, Word, Excel, Outlook and Internet Explorer.
Strong mechanical skills.
Familiarity with the pharmaceutical industry’s concepts, practices and procedures.
Good interpersonal skills, ability to work effectively in a team environment and to lead and train junior staff members.
Ability to follow written and verbal instructions and to react quickly to changes in project priorities and timelines.
Extensive work experience with a wide variety of pharmaceutical manufacturing equipment.
Language/Reading Ability: Ability to independently read and comprehend documents such as safety rules, operating and maintenance instructions, and procedure manuals. Ability to write and complete batch record documentation. Ability to identify details that may not be clearly stated. Using the reading material context, figure out the definition of words not given to them. Apply multiple step instructions to a task that is the same of similar as the one they are reading about (i.e., performing major clean steps on two different machines). Select the correct actions when operational conditions change. (i.e. ability to follow “if-then” statements).
M ath Ability: Ability to solve problems that require multiple operations (add and subtract, add and multiply, subtract and divide, or multiply and divide using several positive or negative numbers – ((12+10-5)/3). Ability to solve problems that require simple ratios, multiple fractions with common denominators, and common fractions or percentages (i.e., add 1/3 + .4 + 50% or multiply 30.6 * 5/8). Ability to calculate averages and perform unit conversions. Ability to arrange problem information into the right order before performing the calculations (i.e., selecting what information needs to be added before dividing the sum).
Reasoning Ability: Ability to determine which details are important to remember.
P h y sical and Mental Demands and Work Environment
P h y sical Demands: The employee must be able to be fit tested to wear a respirator. While performing the duties of this Job, the employee is frequently required to stand. The employee is occasionally required to walk; sit; climb or balance; and stoop, kneel, crouch, or crawl. The employee must occasionally lift and/or move up to 25 pounds, frequently lift and/or move up to 50 pounds, and occasionally lift and/or move more than 50 pounds. Specific vision abilities required by this job include close vision, distance vision, color vision, peripheral vision, depth perception, and ability to adjust focus. Must have corrected visual acuity of 20/40 or better bilaterally. Must be able to pass color/contrast testing passing 9 of 12 elements. The employee must be able to pass a Pulmonary Function Test (PFT) and wear appropriate Personal Protective Equipment (PPE) such as a respirator per site policies and SOPs.
M ental Demands: While performing the duties of this job, the employee is regularly required to use English written and oral communication skills; interact appropriately with staff, management, and others encountered in the course of work; read and interpret a variety of documents and instructions furnished in written, oral, diagram, or schedule form such as safety rules, operating and maintenance instructions, and procedure manuals; collate and interpret technical and engineering data; generate technical reports of investigations; analyze and solve practical problems and deal with a variety of concrete variables in situations where only limited standardization exists; establish priorities and work on multiple assignments and projects concurrently. The employee is regularly required to apply computer skills covering word processing, and spreadsheet software. The employee is regularly required to apply mathematical formulae and engineering rules of thumb to tasks and execute technical and engineering calculations.
W ork Environment: In certain assignments, the employee will regularly work near moving mechanical parts. The employee will occasionally work around and with fumes or airborne particles; toxic or caustic chemicals. The noise level in the work environment is usually moderate to loud.