Senior Mechanical/Electrical Engineer
Unither Pharmaceuticals · Rochester, NY · 1 wk ago
EngineeringFull-time
About the role
We are seeking a Technical Resource to support our company's objectives with respect to engineering design, process, and implementation, focusing on machinery used in the packaging production process. This role serves as a subject matter expert (SME) with regards to filling and packaging systems.
Responsibilities
- Engage in technical discussions with potential suppliers
- Organize and write specifications based on the needs and requirements (URS)
- Launch calls for tenders (Request for Proposal, Request for Service)
- Ensure the solution designed respects the established specifications
- Document and validate technical choices that may deviate from established specifications in a formal manner
- Execute projects and tasks to the approved completion deadlines and within the defined budget
- Work in partnership with external companies
- Propose and apply solutions to mitigate and compensate for possible work delays
- Proactively alert site management to potential problems
- Monitor the installations and commissioning of equipment
- Cook up and coordinate with various suppliers and vendors to ensure their compliance to health and safety instructions
- Possess adequate technical expertise allowing problem resolution
- Respect the data in the specifications
- Communicate with Production to coordinate activities with respect to production constraints
- Assist with commissioning activities and in putting the equipment into production
- Carry out an assessment after each commissioning
- Serve in an expert role in writing feasibility and line trials, qualification protocols, execution of the tests, writing and approval of any resulting reports
- Participate in operator training (training)
- Work with internal customers to define the training requirement and provide technical content
- Organize training in collaboration with suppliers
- Study the technical needs associated with new site investments
- Participate in different project groups
- Collect and analyze needs from internal stakeholders
- Define technical solutions and implementations
- Respect the technical, regulatory and quality requirements issued by Management and Quality Assurance
- Take into account the necessary parameters (water production, energy, etc.)
- Respect flows, workshop ergonomics and safety constraints
- Ensure the documentation of completed projects is updated
- Create technical drawings of the factory and update according to approved documentation practices
Qualifications/Experience
- Minimum 8 years in either a manufacturing environment, or equipment and packaging technology
- Proficiency in CAD and P&ID diagram creation, editing and review
- PMP a plus
- Experience in a regulated environment (FDA) a plus
Skills
- This position requires the ability to think in high level terms to develop engineering solutions for new processes
- The ability to think in specific, detailed terms when problem solving for existing processes
- Strong background in technical troubleshooting, problem solving
- Detailed knowledge of packaging equipment operation, vision systems, and validation requirements
- Ability to work in a matrix organization with cross-functional teams
- Ability to specify, procure, oversee installation, and commission systems and processing equipment
- Strong project management skills
- Batch processing, facilities, building utilities and infrastructure knowledge and experience
- Proficient knowledge of pharmaceutical cGMP requirements and systems a plus
Physical Requirements/Environment
- Traditional office environment, with frequent visits to other areas of the facility, including production areas, loading docks, and laboratories
- Must be able to work on a computer for extended periods of time
- Must wear safety glasses and other protective items as required
- Sitting 75% of the day; standing or walking 25%
Benefits
- 100% employer-paid medical premiums (a $2,000–$6,000+ annual value)
- 401(k) contributions: 6% match plus an additional 4% company-funded contribution
- HSA contributions with wellness incentives
- Annual performance bonuses and merit increase eligibility
- And more—because we invest in your health, your future, and your peace of mind
Pay
$100,000.00 - $115,000.00 USD
Schedule
Traditional office environment, with occasional travel for business (Domestic and International)