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Title

Process Engineer III 

Category Manufacturing  
Description

Primary Objective of Position
The Process Engineer III will be responsible for performing process engineering activities in the manufacturing and packaging areas. Provide technical expertise for new and existing commercial capsule and tablet product families, ensuring a high level of technical competency is applied from process transfer throughout the commercial production lifecycle. Execute project activities associated with technical transfer of commercial products, installation/upgrade of production equipment, and process monitoring and control of commercial production and packaging processes.

Major Duties/Responsibilities
•Routinely monitor all commercial product processes including collection, collation, and analysis of relevant data such as CQAs, CPPs etc. as needed to ensure consistent and alert monitoring of the health and stability of commercial processes, and early warning of troubles or trends.
•Analyze and provide resolution of technical issues by means of formulation, process or machine modifications, providing innovative and regulatory-acceptable solutions to issues at hand.
•Develop project scope, work with vendors and internal stakeholders to establish capital estimates and timelines, and execute small capital projects.
•Identify opportunities for improvement and implement projects to address them.
•Provide technical assistance as required within manufacturing / packaging.
•Lead troubleshooting efforts for process and equipment issues to include risk assessments; lead root cause analysis investigations and implement sustainable solutions.
•Assist with establishing and measuring Key Performance Indexes (KPIs) for the operational areas utilizing Operational Equipment Efficiency (OEE) methods. Assist with process monitoring and trending.
•Provide technical expertise to project management teams during project lifecycles.
•Liaise with other site groups in relation to processing issues
•Assist in the development and maintenance of process equipment, procedures, batch records, training materials, and other technical documents.
•Write technical reports, SOPs, and Change Controls.
•Provide training as related to project/improvement initiatives.
•All other duties as assigned by management

 
Position Requirements Minimum Job Qualifications

Education
Bachelor's degree in Mechanical, Chemical, Electrical or related Engineering or Pharmaceutical Science field. Other science based degrees will be considered based on experience (i.e. Chemistry).

Experience
Minimum eight (8) years of work experience as an engineer in a regulated pharmaceutical facility. Minimum two (2) years of experience within a solid dose finished pharmaceutical manufacturing environment. Direct previous work experience with cGMPs is required, as well as with statistical process control techniques and software.

One - three (1-3) years of leadership experience (supervisory/management/project management) is highly preferred.

Licenses, Certificates, Registrations
•Lean/Six Sigma trained preferred

Knowledge/Skills/Abilities
•Demonstrable knowledge of cGMPs and applicable industry standards
•Proven project management skills
•Ability to prioritize and manage multiple projects simultaneously
•Organizational skills including the ability to create detailed plans and monitor progress against plans
•Strong analytical/ problem solving skills
•Excellent verbal and written communication skills
•Interpersonal effectiveness with the ability to interact with the operational workforce
•High energy level and a creative thinker

Physical and Mental Demands and Work Environment
The physical and mental demands and work environment described here 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 occasionally lift and/or move up to 50 pounds. While performing the duties of this job, the employee is regularly required to walk, stand, talk, hear, use hands to finger, handle, or feel and reach with hands and arms. The employee is occasionally required to sit; climb or balance and stoop, kneel and crouch.

Specific vision abilities required by this job include close vision, distance vision, color vision, peripheral vision, depth perception and the 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 and must be able to pass a peripheral assessment at 80Âş or better.

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 contractors, vendors 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, spreadsheet and presentation 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
As with all Recro positions, the person in this position is responsible for carrying out all duties in a safe and responsible manner.

In certain assignments, the employee will frequently work near moving mechanical parts, fumes, airborne particles, and chemicals, which may require the employee to wear specified Personal Protective Equipment.

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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