Sr. Mfg. Engineer II

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Description:
SUMMARY OF FUNCTIONS:  
Provides Manufacturing Engineering support for contract manufactured and internally manufactured clinical and commercial products (aseptic and terminally sterilized processes). Provides guidance to Manufacturing Engineers.
 
QUALIFICATION REQUIREMENTS:
To perform this job successfully, an individual must be able to perform each essential duty satisfactorily. The requirements listed below are representative of knowledge, skill, and/or ability required. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.
 
ESSENTIAL DUTIES AND RESPONSIBILITIES:
Project/Team leader for new and existing process related changes (project management).
Participates in manufacturing management and planning meetings.
Assists with budget and scheduling for the department.
Participate on product development teams during the design validation and verification phases.
Initiate and execute equipment and process qualifications.
Perform aseptic operations in accordance with current industry standards.
Transition new products from Product Development to Contract Manufacturing suppliers including Bills of Materials, refinement of documentation to define both the product and manufacturing process in accordance with the US FDA QSR Design Control and Design Transfer requirements.
Assist Documentation with administration of Production Systems/Equipment Files. With Documentation, maintain equipment/systems master list.
ORGANIZATIONAL RELATIONSHIPS:
Reports to the Manager, Manuf. Engineering. Works closely with all departments throughout the organization.
 
SUPERVISORY RESPONSIBILITIES
Supervise work through the planning and scheduling of work, and the review and approval of tasks. May direct or guide the work of the Manufacturing Associates and Manufacturing Engineers.
 
WORK SCHEDULE/HOURS
This position works 8:00 AM-5:00 PM, M-F. Flexible work schedule is required to meet company goals and objectives.   During production of certain products hours will change. Occasional weekend hours and extended shifts required in order to meet the production schedule. 
 
SKILLS, EXPERIENCE AND EDUCATIONAL REQUIREMENTS:
A Bachelors degree in engineering from a four-year college or university with a minimum of 5-7 years related experience and/or training. 
Experience with a US FDA and or/ EU MDD regulated medical device or pharmaceutical company preferred. 
Experience processing resin-based, bis-glycidal dimethacrylate (Bis-GMA) or similar composites DESIRED!!!!
Cleanroom and aseptic filling experience in a pharmaceutical or medical processing company is preferred. 
Project management experience is preferred. 
Knowledge of electromechanical systems with various controls, PLC experience preferred. 
Ability to read, analyze, and interpret general business periodicals, professional journals, technical procedures, or governmental regulations.
Ability to write reports, business correspondence and procedure manuals. Ability to effectively present information and respond to questions from groups of managers, clients, customers and the general public. 
Ability to work with mathematical concepts such as probability and statistical inference, and fundamentals of plane and solid geometry and trigonometry. 
Ability to apply concepts such as fractions, percentages, ratios, and proportions to practical situations.  
Ability to solve practical problems and deal with a variety of concrete variables in situations where no standardization may exist. Ability to interpret a variety of instructions furnished in written, oral, diagram, or schedule form.
Proficient in Microsoft Office Suite skills including electronic mail, record keeping, routine database activity, word processing, spreadsheets, graphics, project management, etc. CAD software skills required (Solidworks preferred).
PHYSICAL DEMANDS:
The physical demands described here are moderate and represent those that must be met by an employee to successfully perform the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions. While performing the duties of this job, the employee is frequently required to stand, sit, talk, hear and use tools, or controls. The employee is occasionally required to reach with hands and arms, climb, stoop, kneel, crouch or crawl.    The employee must frequently lift and/or move up to 25 lbs and may occasionally lift and/or move up to 50 lbs. Specific vision abilities required by this job involve normal vision. 
 
WORK ENVIRONMENT:
The work environment characteristics described here are representative of those an employee encounters while performing the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.   The noise level in the work environment is usually moderate. Individuals will work in well lighted, heated and/or air conditioned indoor office/manufacturing, cleanroom environment with adequate ventilation. Occasionally around equipment with safety concerns and in unpleasant work environments. Cleanroom environment, will work with various chemicals (process and cleaning). Occasionally will work in confined spaces such as an isolator.
 
TRAINING AND STANDARD OPERATING PROCEDURES:
Employee is required to participate in all in-house training and education programs as instructed by their Manager. Upon hire and annually thereafter, all employees are required to read, adhere to and acknowledge receipt of Orthovita’s Corporate Governance Documents. 
 
Orthovita offers competitive compensation with an extensive benefits package. If you are interested in this position, please visit our website www.orthovita.com to complete an on-line application.
 
Orthovita is an equal opportunity and Affirmative Action employer and does not discriminate against otherwise qualified applicants on the basis of race, color, creed, religion, ancestry, age, sex, marital status, sexual orientation, national origin, disability or handicap, or veteran status. We encourage minorities, females and veterans to apply. NO PHONE CALLS OR RECRUITERS!! ...

Apply by eMail:do_not_reply@invalidemail.com

Job Created: Sat Aug 01 2009 05:38:25 AM
Last Modified: Sat Nov 21 2009 07:51:06 AM