What are the responsibilities and job description for the Pharma Project Engineer II position at PROMED MOLDED PRODUCTS INC?
POSITION SUMMARY
The Project Engineer II coordinates projects to develop manufacturing processes for complex dosage pharmaceuticals and combination medical devices. Responsible for planning and coordinating technical tasks associated with feasibility work, equipment definition, testing, and documentation. Works with management to support relationships with customers. This position operates under minimal guidance from management or senior staff. The Project Engineer II ensures ProMed’s brand, philosophy, systems, policies, and procedures are properly implemented and observed.
ESSENTIAL DUTIES & RESPONSIBILITIES
Position duties and responsibilities include, but are not limited to the following:
Lead and contribute to projects (75%)
- Partner with Business Development to create feasibility proposals and plans
- Lead small teams to complete feasibility work
- May simultaneously lead multiple early-stage feasibility projects
- Take ownership of portions of large development projects
- Ensure team uses the Process Development Procedure
- Collaborate with internal and customer teams to generate ideas and solve technical problems
- Plan, design, and execute experiments in laboratory and clean room environments
- Analyze data to help drive team and customer decisions
- Execute equipment and process qualification and validation
- Develop manufacturing procedures, test methods, standard operating procedures, and protocols
- May guide work of technicians and/or less senior staff
Document and communicate (25%)
- Maintain thorough and compliant laboratory notebooks
- Author reports and presentations for internal teams and clients
- Communicate effectively with internal teams and customers
- Provide timely communication on project progress to immediate team and supervisor
This job also requires performing other duties as assigned.
QUALIFICATION, EDUCATION & EXPERIENCE
To perform this job successfully, an individual must be able to perform each essential duty satisfactorily. The requirements listed below are representative of the knowledge, skill, and/or ability required. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.
Required:
• B.S. ( 3 years of experience) or M.S. in an engineering or physical science field
-OR-
- Six years of experience in a regulated environment in lieu of education requirements
Preferred:
- Proficient with MS Office
- Experience with Minitab, Solidworks
- Ability to write clear technical documents
- Demonstrated aptitude for development in the medical device and pharmaceutical industry
- Strong technical skills/knowledge
- Problem-solving and critical thinking skills
- Demonstrated ability to prioritize tasks across multiple projects to meet objectives
WORK ENVIRONMENT
The work environment characteristics described here are representative of those an employee encounters while performing the principal roles and responsibilities of this job.
- Exposure to heated/air conditioned, ventilated facilities with fluorescent lighting;
- Exposure to building where a variety of chemical substances are used for cleaning, and/or operation of equipment;
- The noise level in the work environment is usually minor;
- Duties are performed indoors;
- Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.
PHYSICAL, SENSORY, COGNITIVE & NEUROLOGICAL DEMANDS
While performing the duties of this job:
- The employee may be required to stoop, bend, squat, kneel, reach, stand, walk, lift, pull, push, grasp, talk, hear, see and use repetitive motions;
- Specific vision abilities required include close vision such as to read handwritten or typed material and the ability to adjust focus;
- The position requires the individual to meet multiple demands from several people and interact with internal and external people;
- Employee moves about the building and be able to maneuver in tight spaces between desks, etc.;
- Employee may have duties involving walking on even or uneven surfaces;
- Employee occasionally to frequently use a whiteboard, which can require grasping whiteboard pens, reaching at, below, or above shoulder height and may require trunk or neck rotation to look back;
- Employee may use computers, overhead projectors, TV, VCR, and other work-related equipment, which may require an approximately 25 pound force to push or pull equipment;
- It is necessary to grasp and manipulate pens, markers, scissors, staplers, etc. occasionally to frequently.
- Employee must see and hear on a continuous basis as well as speak frequently;
- Position varies from standing, sitting, walking, etc. On some occasions it may be necessary to move quickly, run, etc. over smooth or uneven surfaces.
ProMed offers a generous benefits package including:
- 401k with company match
- Profit Sharing program
- Medical Insurance
- Health Savings Account/Flexible Spending Account
- Dental Insurance
- Vision Insurance
- Life Insurance
- Short, and Long-Term Disability Insurance
- Critical Illness, Accident, and Identity Theft Protection
- Pet Insurance
ProMed does not discriminate in employment opportunities or practices on the basis of race, color, creed, religion, national origin, ancestry, age, sex, marital status, order of protection, disability, military status, sexual orientation, gender identity, pregnancy, public assistance, family status, unfavorable discharge from military service, genetic information or other segmenting factor protected by law, or local human rights commission activity.
Salary : $75,000 - $120,000