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Title

Process Development Technician II (Chestnut Facility) 

Category Research & Development  
Description

Primary 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).

Major 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.

 
Position Requirements

Minimum Job Qualifications

 

Education

 

High School Diploma or General Education Degree (GED).

 

 

Experience

 

At least 5 years’ experience in related pharmaceutical manufacturing work, including at least 2 years’ experience in solid oral dosage pharmaceutical manufacturing work.

 

 

Knowledge/Skills/Abilities

 

Working knowledge of cGMP regulations and safety procedures, Microsoft Windows, Word, Excel, Outlook and Internet Explorer.

 

Language/Reading Ability:

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.

 

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).

 

Math 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.

 

Physical and Mental Demands and Work Environment

 

The physical and mental demands and work environment described her are representative of those that must be met by an employee to successfully perform the essential functions of the job. Reasonable accommodations may be made to enable individuals with disabilities to perform essential functions.

 

Physical 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.

 

 

Mental 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.

 

Work 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.

 
About the Organization Societal is a bi-coastal contract development and manufacturing organization (CDMO) with expertise to deliver on our client's needs, regardless of complexity level. These projects span pre-Investigational New Drug (IND) development to commercial manufacturing and packaging for a wide range of therapeutic dosage forms. We provide industry leading support for small molecule therapeutic development, end-to-end regulatory support, clinical and commercial manufacturing, aseptic fill/finish, lyophilization, packaging and logistics services to the global pharmaceutical market. We do all of this in our best-in-class facilities in San Diego, California and Gainesville, Georgia.

New hires will pass a background check and drug screen as a condition of employment.  
EOE Statement We are an EOE dedicated to a diverse workforce and a Drug-Free work environment. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability, status as a protected veteran, or any other characteristic protected by law. If you require an accommodation to complete the application or interview process, please contact careers@societalcdmo.com.  
EmpID None Specified 


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