Position Summary:
The Project Engineer II will be responsible for contributing to the successful completion of global engineering projects as well as developing internal engineering procedures. The Project Engineer II will primarily focus on the completion of medium size engineering projects with moderate complexity that will support large and complex Engineering projects related to capital expenditures.
Duties and Responsibilities:
- Develops project deliverables for medium engineering projects, including but not limited to the Capital Acquisition Request, Project Scope, Project Schedule, and Project Budget.
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Creates and maintains project schedules, budgets and documentation for medium engineering projects up to $2,500,000.
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Oversees the completion of medium engineering projects.
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Manages the purchase of multiple capital equipment according to the Capital Program.
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Aids in the creation of User Requirement Specifications necessary for project completion.
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Aids in the development of Capital Acquisition Request, Project Scope, Project Schedule, and Project Budget for large engineering projects.
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Provides engineering expertise to design elements of the project.
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Provides engineering solutions for all engineering projects.
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Provides documentation essential to the turnover of the completed project to Manufacturing Engineering.
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Performs equipment qualification and validation (FAT/SAT) according to approved protocols.
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Partners with contractors as required.
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Escalates issues or concerns when necessary.
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Coordinates with material/equipment vendors.
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Provides technical engineering expertise to facilities and engineering staff.
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Assists in setting up total preventative maintenance programs for machines and equipment.
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Assists with all engineering projects and facility modifications.
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Assist with the coordination of engineering project shutdowns to ensure the availability of resources for timely completion.
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Assists with safety assessments for modifications to equipment.
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Keeps up to date with regulatory guidance for compounding pharmacies/outsourcing facilities.
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Adheres to Quality and safety guidelines by communicating with management in a timely manner of regulatory inspections, such as serious Good Manufacturing Practice (GMP) deficiencies, product defects, and related actions (e.g., quality-related complaints, recalls, regulatory actions, etc.).
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Performs other duties as assigned.
To perform this job successfully, an individual must be able to perform each essential function satisfactorily. The requirements listed above are representative of the knowledge, skill, and/or ability required. Reasonable accommodations may be made to enable qualified individuals with disabilities to perform essential functions.
Work in an office environment most of the time, but the employee will spend considerable time working in construction areas, utility areas, and clean room areas. Must have the ability to climb ladders, work on feet for extended periods, and lift packages/equipment of up to 50 lbs. While performing the responsibilities of the job, the employee is required to talk and hear. The employee is often required to remain in a stationary position for a significant amount of the workday and frequently use their hands and fingers to handle or feel in order to access, input, and retrieve information from the computer and other office productivity devices. The employee is regularly required to move about the office and around the corporate campus. The employee is regularly required to stand, walk, reach with arms and hands, climb or balance, and to stoop, kneel, crouch or crawl. Vision abilities required by this job include close vision.
Knowledge and Skills:
- Ability to effectively communicate at all levels, strong problem-solving ability, solid technical knowledge, appropriate feedback/follow-up, effective planning, and work management skills are required of this role.
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Proficient in Microsoft Office Skills-Excel, Word, PowerPoint, Outlook.
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Ability to cope with varied levels of workload and multiple tasks.
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Ability to work in a fast-paced, team environment.
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Excellent attention to detail.
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Flexible and proactive to meet varied company needs.
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Basic AutoCAD skills preferred.
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Professional Engineer preferred.
Key Competencies
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Customer Focus: Ability to build strong customer relationships and deliver customer centric solutions.
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Optimizes Work Processes: Know the most effective and efficient processes to get things done, with a focus on continuous improvement.
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Collaborates: Builds partnerships and works collaboratively with others to meet shared objectives.
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Resourcefulness: Secures and deploys resources effectively and efficiently.
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Manages Complexity: Makes sense of complex, high quality, and sometimes contradictory information to effectively solve problems.
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Ensures Accountability: Holds self and others accountable to meet commitments and objectives.
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Situational Adaptability: Adapts approach and demeanor in real time to match shifting demands of different situations.
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Communicates Effectively: Develops and delivers multi-mode communications that convey a clear understanding of the unique needs of different audiences.
Experience and Qualifications:
- Bachelor’s degree in chemical or mechanical Engineering required.
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3-6 years of hands-on application of engineering principles to plant systems.
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3-6 years of experience in a cGMP-compliant engineering environment.
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Previous experience in troubleshooting operational and design issues within an industrial environment.
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Pharmaceutical/process experience preferred.
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Previous experience in the management and coordination of engineering consultants, equipment vendors, and contractors is preferred.
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Pharmaceutical and/or Bio-pharma industry experience preferred.
Benefits:
- No-Cost Medication: Get your prescribed compounded medications at no cost, ensuring your health without the financial burden.
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Onsite Health & Wellness – IV Therapy Drips: Rejuvenate with complimentary onsite IV Therapy drips, enhancing your well-being and energy levels.
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Comprehensive Medical, Dental, and Vision Options: Choose from three medical plans tailored to your needs, plus options for dental and vision coverage for you and your family.
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Telehealth visits: Access board-certified Doctors anytime, anywhere for you and your family.
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Paid & Volunteer Time Off: Enjoy paid time off for personal pursuits and contribute to causes you care about with volunteer time off.
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Paid Holidays (8 scheduled; 2 floating): Celebrate with eight scheduled holidays and two floating holidays, giving you flexibility and time for personal traditions.
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Life & AD&D Coverage: Secure your and your family's financial future with life and accidental death and dismemberment (AD&D) insurance.
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FSA (Flexible Spending Account): Manage healthcare expenses smartly with pre-tax dollars in a Flexible Spending Account (FSA).
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401K Dollar-for-Dollar Up to 4%: Invest in your future with our 401K plan, featuring a dollar-for-dollar match up to 4%.
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Company Paid Long-Term Disability: Provided at no cost, which replaces 60% of your income if you become disabled for a long period of time.
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Flexible Schedules: Balance work and life seamlessly with our flexible scheduling options.
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Rewards & Recognition Program: Your hard work doesn't go unnoticed – enjoy rewards and recognition beyond your paycheck.
Additional Voluntary Benefits
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Accident Insurance: Pays a lump sum benefit to help cover expenses following an accidental injury.
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Hospital Indemnity Insurance: Enhance your peace of mind with supplemental hospital insurance for unexpected stays.
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Critical Illness: Protect your finances from the expenses of a serious health issue.
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Short-Term Disability: Protect your income during illness or injury with short-term disability coverage.
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Supplemental Life & AD&D: Add an extra layer of financial protection for you and your loved ones with supplemental life and AD&D coverage.
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Legal Services: Access professional legal assistance to address concerns confidently.
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Identity Theft Protection: Safeguard your identity and finances with our identity theft protection benefit.
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Pet Insurance: Care for your furry family members with our pet insurance coverage.
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Employee Assistance Program: Confidential counseling and support services for a holistic approach to your well-being.