|at ( view profile)|
|Date Posted||July 24, 2019|
Contract GMP Manufacturing
|Address||W132N10550 Grant Drive|
The Project Engineer is accountable for driving results in a fast-paced environment by being responsible for multiple capital related projects, validation and is a “hands-on", on-the-floor, Project Leader, with a record of designing, and executing projects on time and within budget. The Project Engineer works closely with cross-functional departments to understand the scope, user requirements and needs of the project and develops the project implementation plan. The Project Engineer also reviews and designs for quality compliance, safety, and adherence to company standards, developing communications and risk management plans when needed. The position requires superior leadership behaviors of the Alcami core competencies and non-negotiables, as well as expertise in functional competencies included in this position profile.
- Develops project objectives working with user requirements and business plans;
- Determines project specifications and technology and completes preliminary technical studies; determines project phases and prepares cost estimates;
- Participates in internal discussions with internal customers to determine timing for project execution and sequencing of various project milestones;
- Establishes equipment specifications with internal customers;
- Works with leaders to schedule and execute validation activities, identifies/resolves validation issues and designs validation test plans. Authors and follows up on closure documentation for IQ, OQ and PQ.
- Creates and reviews SOPs and related manufacturing process documentation. Performs duties related to Corrective and Preventative Action (CAPA) plans, deviations and Change Control (CC).
- Provides validation, facilities and utilities support for new or modified equipment used to manufacture new active pharmaceutical ingredients.
- Request bids from contractors and suppliers by providing; working with procurement group, recommends best provider;
- Formal CAPEX document preparation and submission;
- Controls project plan and maintains project schedule by close monitoring of project progress; coordinating activities on critical path;
- Controls project costs by approving expenditures; administers contracts and monthly expenditures against planned cash flow;
- Prepares project status reports;
- Responsible for commissioning and coordinating equipment/areas for validation;
- Maintains company reputation by complying with applicable federal and state regulations.
- Ensures timely completion and compliance with cGMP and all other relevant company training requirements.
Education and Experience
- Bachelor’s Degree in engineering in Chemical / Mechanical / Electrical / Facility / Pharmaceutical preferred
- Minimum 4 years’ experience in engineering project planning/management.
- Consistently demonstrates honesty and integrity through personal example.
- Follows all safety policies and leads by example a safety first culture.
- Produces high quality work product with a focus on first time right.
- Complies with the company code of conduct and policies and regulatory standards.
Alcami Core Leadership Competencies
- Thinks strategically. Quickly identifies and acts on opportunities. Considers the downstream impact. Seeks to understand the why. Focuses on work that matters.
- Develops organization and others. Takes ownership to develop self and others. Seeks out new opportunities and experiences for continuous learning.
- Acts decisively. Makes and acts on decisions quickly. Makes decisions with the customer and their patients in mind. Meets commitments with a sense of urgency. Seeks ways to be more efficient.
- Drives performance. Holds self and others accountable. Delivers results first time right. Never settles for status quo. Willing to have tough conversations. Asks for feedback and takes action to improve.
- Passion for customers. Listens to understand. Asks the right questions. Gets to the heart of the matter and uses that insight to provide value.
- Works collaboratively. Seeks out the experience of others with the aim for better results. Open minded regardless where ideas originate. Flexible and easy to work with.
- Performs assigned tasks carefully and on schedule according to standard operating procedure and supervisor instructions.
- Demonstrates company loyalty in relations with company personnel.
- Maintains a safe, clean and organized work environment free of safety hazards.
- The ability to work with people at all levels of the organization.
- Ability to perform complex math functions, compute ratios, rates, and percentages.
- Ability to draw and interpret graphs and charts.
- Ability to solve practical problems and deal with a variety of concrete variables in situations where limited standardization exists.
- Ability to interpret a variety of instructions furnished in written, oral, diagram or schedule form.
- Previous work experience in regulated Active Pharmaceutical Ingredients manufacturing environment preferred.
- Excellent verbal communications and presentation skills required.
- Proficiency with Microsoft Office (Word, Excel, PowerPoint) required.
- Proficiency with Autocad, MS Project preferred
What We Offer You:
- Competitive salary with career advancement opportunities
- Profit sharing bonus plan
- Medical, dental and vision coverage from day one
- 401(k) with company match
- Company paid vacation, holiday and sick-leave
- Voluntary benefits including short & long term disability, life, accident, critical illness insurances