Project Engineer

The Project Engineer is responsible for coordinating and scheduling Project Engineering work.  Projects include atypical preventive maintenance and planned Capital Project work.  The Project Engineer must have experience with complete asset management lifecycle from concept to retirement of an asset as well as a strong background in facilities management activities which will include conceptual design thru validation and into operations.  The position defines and implements necessary facilities improvements to maintain current GMP and Industry Best practices and implements changes to enhance effectiveness at increasing value-maximizing performance.  Implementation is accomplished by directing in-house resources, system integrators, consultants, and contractors to design, plan, coordinate, and execute engineering activities specifically related to capital and expenses project budgets.

• Project budget creation and execution.
• Executes the preparation of Project Manuals, Design Drawings, Specifications, and Cost estimates by outside engineering firms for all phases of a project.
• Investigates potential projects, develops justifications, and executes approved projects to completion.
• Coordinates, facilitates and executes the coordination of project activities with affected departments including Manufacturing, Quality Assurance, Validation, Safety and Environmental.
• Small/Large project execution information controls.
• Executes the preparation of designs, specifications, and cost estimates of a project.
• Provides documentation to Validation on a timely basis for new projects or any design changes that are proposed or implemented.
• Customer interface and support from A/E firms w/ construction management.
• Leads and organizes activities of cross-functional project teams to assure completion of all phases of capital projects in a timely and efficient manner.
• Support the development and management of a contract maintenance associate program.
• Coordinates the installation of plant & process equipment, such as air handlers, stability chambers and packaging equipment.
• Observes conditions in all areas of the plant, i.e., on roofs, above ceilings, out-of-doors, etc., for the purpose of directing contractor personnel and obtaining information necessary to direct the preparation of engineering drawings and specifications.
• Development of SOPs, as required, to assure that newly engineered systems be operated as designed.
• Executes the development and preparation of required cGMP documentation for complex pharmaceutical systems, including IQ/OQ/PQ protocols.
• Observes safe operating practices and established safety rules.
• Reviews project work for compliance with cGMPs, OSHA regulations, and loss prevention insurer’s requirements.
• Responsible for the spending of funds for Capital Improvement Projects to assure that project spending is controlled and that Project Change Orders and CIP Supplements are submitted and approved before project budgets are exceeded.

Education & Experience

• Bachelor’s in a field related to engineering, mechanical or electrical required.
• Project Management Certification preferred.
• Minimum 5 years specializing in pharmaceutical related environment.
• Experience in designing and installing clean rooms, liquids manufacturing and packaging equipment, purified water systems, sanitary pipelines.

Knowledge

• Excellent computer skills
• Proven organizational and supervisory skills.

Skills  &  Abilities

• Proven project management skills with on-time, on-budget delivery
• Cost-conscious mindset with experience managing budgets and resources
• Strong analytical and problem-solving abilities
• Solid technical aptitude with a commitment to continuous learning
• Clear and effective oral and written communication skills
• Collaborative team player with strong interpersonal skills
• Demonstrated leadership and ability to influence others
• Sound judgment with timely decision-making
• Highly motivated with the ability to meet challenging goals
• Strong planning, organization, and time-management skills
• Experience managing and developing people while driving continuous improvement

The anticipated annual base salary range for this position in New Jersey is $90,000 to $120,000, plus a discretionary performance bonus (based upon eligibility). The final salary offered to a successful candidate may vary and will be dependent on several factors that may include but are not limited to: the type and length of experience within the job, the type and length of experience within the industry, skillset, education, business needs, etc. Lupin is a multi-state employer, and this salary range may not reflect positions that work in other states