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Project Manager, Engineering

Strides Pharma Inc. Chestnut Ridge, NY

Job Description Job Title Project Mgr, Engineering Company Strides Pharma, Inc Function Engineering Location(s) Chestnut Ridge Department Engineering Services Direct Reports (list) N/A Reports to (title) Manager, Engineering Date Submitted Job Summary - a concise overview of the job The Project Manager, Engineering is responsible for coordinating and scheduling Project Engineering work. Projects include atypical preventive maintenance and planned Capital Project work. The Project Manager 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. All incumbents are responsible for following applicable Division & Company policies and procedures. Scope of Authority - span of control (work unit, site, department, division, etc.), monetary value of budget/spend authority ( capital, operating, etc.), P&L responsibility, etc. Budget Responsibilities Range ($50K- $3M) Annual expense and capital projects Key Accountabilities - key outcomes/deliverables, the major responsibilities, and % of time Accountability Responsibilities % of Time Project Management Project budget creation and execution. 30% 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 Relations Customer interface and support from A/E firms w/ construction management. 10% Leadership Leads and organizes activities of cross-functional project teams to assure completion of all phases of capital projects in a timely and efficient manner. 10% Support the development and management of a contract maintenance associate program. Project engineers the installation of plant process equipment, such as water systems, sterilizers and freeze dryers. 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. Process Development & Execution Development of SOPs, as required, to assure that newly engineered systems be operated as designed. 20% Executes the development and preparation of required cGMP documentation for complex pharmaceutical systems. Compliance Observes safe operating practices and established safety rules. 20% Reviews project work for compliance with cGMPs, OSHA regulations, and loss prevention insurer's requirements. Fiscal 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. 10% Total 100% Qualifications Education & Experience Minimal acceptable level of education, work experience and certifications required for the job 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 Proficiency in a body of information required for the job e.g. knowledge of FDA regulations, GMP/GLP/GCP, Lean Manufacturing, Six-Sigma, etc. Excellent computer skills. Proven organizational and supervisory skills. Skills Abilities Often referred to as "competencies", leadership attributes, skills, abilities or behaviors that may be enterprise, functional or job specific e.g. coaching, negotiation, calibration, technical writing etc. Project Management - Develops project plans; Coordinates projects; Communicates changes and progress; Completes projects on time and budget; Manages project team activities. Cost Consciousness - Works within approved budget; Develops and implements cost saving measures; Contributes to profits and revenue; Conserves organizational resources. Problem Solving - Identifies and resolves problems in a timely manner; Gathers and analyzes information skillfully; Develops alternative solutions; Works well in group problem solving situations; Uses reason even when dealing with emotional topics. Technical Skills - Assesses own strengths and weaknesses; Pursues training and development opportunities; Strives to continuously build knowledge and skills; Shares expertise with others. Oral Communication - Speaks clearly and persuasively in positive or negative situations; listens and gets clarification; Responds well to questions; Demonstrates group presentation skills; Participates in meetings. Written Communication - Writes clearly and informatively; Edits work for spelling and grammar; Varies writing style to meet needs; Presents numerical data effectively; Able to read and interpret written information. Teamwork - Balances team and individual responsibilities; Exhibits objectivity and openness to others' views; Gives and welcomes feedback; Contributes to building a positive team spirit; Puts success of team above own interests; Able to build morale and group commitments to goals and objectives; Supports everyone's efforts to succeed. Leadership - Exhibits confidence in self and others; Inspires and motivates others to perform well; effectively influences actions and opinions of others; Accepts feedback from others; Gives appropriate recognition to others. Judgment - Displays willingness to make decisions; Exhibits sound and accurate judgment; Supports and explains reasoning for decisions; Includes appropriate people in decision-making process; Makes timely decisions. Motivation - Sets and achieves challenging goals; Demonstrates persistence and overcomes obstacles; Measures self against standard of excellence; Takes calculated risks to accomplish goals. Planning/Organizing - Prioritizes and plans work activities; Uses time efficiently; Plans for additional resources; Sets goals and objectives; Organizes or schedules other people and their tasks; Develops realistic action plans. Managing People - Includes staff in planning, decision-making, facilitating and process improvement; Takes responsibility for subordinates' activities; Makes self-available to staff; Provides regular performance feedback; Develops subordinates' skills and encourages growth; Solicits and applies customer feedback (internal and external); Fosters quality focus in others; Improves processes, products and services.; Continually works to improve supervisory skills. Physical Requirements Physical & mental requirements e.g. lift 40 pounds, walk across plant/warehouse, business travel (% of time), driving as part of work responsibilities, etc. May be required to work in the following environments: Office Building rooftops, catwalks, crawl spaces Machine rooms Shop areas Manufacturing areas Warehouse Laboratories Plant Site Will sit or stand for long periods of time throughout the day. Required to lift up to 50 lbs. Will walk and climb stairs. Will reach over shoulder heights and below waist. Required to use hands to lift, handle, carry or feel. May be required to kneel, bend, talk and hear. Disclaimer: The above statements are intended to describe the general nature and level of work performed by employees assigned to this job. They are not intended to be an exhaustive list of all duties, responsibilities, and qualifications. Management reserves the right to change or modify such duties as required.

Jobs in Chestnut Ridge