Project Engineering Group Lead at CORDEN PHARMA

, Colorado, United States -

Full Time

Start Date

Immediate

Expiry Date

30 Jan, 26

Salary

0.0

Posted On

01 Nov, 25

Experience

10 year(s) or above

Remote Job

Yes

Telecommute

Yes

Sponsor Visa

Skills

Project Management, Engineering Design, Cost Estimation, Regulatory Compliance, Conflict Resolution, Mentoring, Technical Leadership, Budget Management, Communication Skills, Problem Solving, Team Building, Process Design, Construction Supervision, Quality Control, Safety Compliance, Financial Analysis

Industry

Pharmaceutical Manufacturing

Description

CORDENPHARMA IS A LEADING FULL-SERVICE CONTRACT DEVELOPMENT AND MANUFACTURING ORGANIZATION (CDMO) SPECIALIZING IN ACTIVE PHARMACEUTICAL INGREDIENTS (APIS), EXCIPIENTS, DRUG PRODUCTS (DPS), AND PACKAGING. WITH AROUND 3,000 EMPLOYEES WORLDWIDE, WE HELP PHARMACEUTICAL, AND BIOTECH COMPANIES MANUFACTURE MEDICINES WITH THE ULTIMATE GOAL OF IMPROVING PEOPLE’S LIVES. OUR NETWORK, SPANNING EUROPE AND THE U.S., PROVIDES FLEXIBLE AND SPECIALIZED SOLUTIONS ACROSS SIX TECHNOLOGY PLATFORMS: PEPTIDES, LIPIDS & CARBOHYDRATES, INJECTABLES, HIGHLY POTENT & ONCOLOGY, SMALL MOLECULES, AND OLIGONUCLEOTIDES. WE STRIVE FOR EXCELLENCE IN SUPPORTING THIS NETWORK AND ARE COMMITTED TO DELIVERING THE HIGHEST QUALITY PRODUCTS FOR PATIENT WELL-BEING. OUR PEOPLE VISION WE STRIVE FOR EXCELLENCE. WE SHARE OUR PASSION. TOGETHER, WE MAKE A DIFFERENCE IN PATIENTS' LIVES. SUMMARY The Project Engineering Group Lead is responsible for providing technical leadership for project engineers; as well as managing and executing capital projects in support of pharmaceutical drug substance, intermediates, and fine chemical development and production. The Project Engineering Group Lead provides strong technical leadership in the areas of civil, mechanical, and equipment and facilities design and installation projects. Also, providing leadership to ensure project costs, schedules, quality control, and adherence to regulatory laws and practices throughout the project life cycles. Interacting with management in developing project objectives, department goals, and site concepts and strategies; advises management regarding technical opportunities and advances. ESSENTIAL DUTIES AND RESPONSIBILITIES Include the following. Other duties may be assigned. * Takes a lead role in working with the project owner and supporting staff to develop the project business case and project objectives. Ensures relevant alternatives are evaluated and the recommended solution is supported by local staff and management. Generates and communicates (i.e., presentations), and effectively builds consensus for proposals with project stakeholders as well as management * Plans, develops, coordinates, and directs the entire engineering effort for assigned projects; and mentors and coaches on other projects with many complex features, while ensuring project success. Directs efforts relating to the generation of cost estimates, as well as cost and schedule tracking. Proactively demonstrates responsibility for ensuring that cost, scope, and schedule requirements are met * Reviews project design for compliance with engineering principles, company standards, customer contract requirements, and related specifications. Leads the evaluation of the feasibility and soundness of proposed engineering designs and procedures. Performs as a staff advisor and consultant as to a technical specialty, a type of facility or equipment, or a program function (involving the integration of several business systems) * Develops and evaluates plans and criteria for a variety of projects and activities to be carried out by others. Secures resources for specific phases or aspects of project such as technical studies, system design, preparation of specifications and technical plans, construction, and qualification * Leads timely resolutions of disputes & conflict resolution with external contractors, vendors, and stakeholders * Coaches, mentors and trains less experienced engineers and other project engineering personnel on technical and business issues; plans for and manages change by helping employees understand and accept change in a productive manner * Project activities include, but are not limited to user requirement specification input and review; scope development; process design; funding request preparations; evaluation of equipment system standards and specifications; project controls; implementation logistics; resolving internal and external disputes; resolving engineering design and performance problems; construction supervision; building permits; and qualification and validation efforts * Interacts with customers as “Technical Lead” for Project Engineering concerns * Provides updates (formal and informal) to Production Management and LT, as needed, regarding project progress, issues/issue resolution, and results LEADERSHIP & BUDGET RESPONSIBILITIES Provides leadership to project engineers in the including goal setting: work assignment, planning and prioritization; personal development and training; and coaching/mentoring. This position is responsible for providing leadership and management to assigned projects and is responsible for developing scopes, justifications, cost budgets, personnel requirements, and timelines for ensuring that all major project objectives are met. Provides leadership to other engineers. Fosters a project team atmosphere that facilitates positive employee morale. Willingness to take on significant challenges and difficult assignments without the promise of special rewards or recognition. Supervisory responsibilities include daily leadership of team; training and development; interviewing and hiring; managing time and attendance records; performance appraisals; rewarding and disciplining employees; and resolving daily problems and conflicts. SAFETY & ENVIRONMENTAL RESPONSIBILITIES Every individual is personally responsible for the safety and environmental aspects of his or her activities in the workplace. Each employee is expected to perform their job duties in a safe manner utilizing all their knowledge, training, ability, and experience. QUALIFICATIONS To perform this job successfully, an individual must be able to perform each essential duty satisfactorily. The requirements listed below are representative of the knowledge, skill, and/or ability required. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions. EDUCATION AND/OR EXPERIENCE Bachelor's Degree in Chemical Engineering (BSChE) from 4-year college or university preferred; along with 10 years related experience and/or training; or equivalent combination of education and experience. LANGUAGE SKILLS Ability to read, analyze, and interpret common scientific and technical journals, financial reports, and legal documents. Ability to respond to common inquiries or complaints from customers, regulatory agencies, or members of the business community. Ability to write reports and proposals that conform to prescribed style and format. Ability to effectively present information to top management, public groups, and/or technical staff. MATHEMATICAL SKILLS Ability to comprehend and apply principles of advanced calculus, modern algebra, and advanced statistical theory. Ability to understand basic accounting and financial principles (ROI & IRR analysis, cashflow, committed vs. actual costs, etc.) as they apply to project management. REASONING ABILITY Ability to apply principles of logical or scientific thinking to a wide range of intellectual and practical problems. Ability to deal with nonverbal symbolism (formulas, scientific equations, graphs, etc.,) in its most difficult phases. Ability to deal with a variety of abstract and concrete variables. CERTIFICATES, LICENSES, REGISTRATIONS NONE. TRAVEL MUST BE ABLE TO TRAVEL DOMESTICALLY AND INTERNATIONALLY. PHYSICAL DEMANDS The physical demands described here are representative of those that must be met by an employee to successfully perform the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions. While performing the duties of this job, the employee is regularly required to talk or hear. The employee frequently is required to sit and work with hands. The employee is occasionally required to stand; walk; reach above shoulder height; climb or balance; stoop, kneel, crouch, or crawl; and taste or smell. The employee must occasionally lift and/or move up to 50 pounds. Specific vision abilities required by this job include close vision, distance vision, and ability to adjust focus. WORK ENVIRONMENT The work environment characteristics described here are representative of those an employee encounters while performing the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions. While performing the duties of this job, the employee is occasionally exposed to wet and/or humid conditions; moving mechanical parts; high, precarious places; outside weather conditions; extreme cold; and extreme heat. The noise level in the work environment is usually quiet. While performing the duties of this job, the employee is occasionally exposed to moving mechanical parts, and fumes or airborne particles, and noise typical of an office environment. CORE COMPETENCIES These are the specific areas of knowledge, skill and ability that are important for successful job performance. They must be job related and consistent with business necessity. * Demonstrated expert ability in engineering project management and construction management. Knowledge of project controls, including scheduling, budgeting, and change order systems. Proven ability in managing simultaneous projects of significant value * Prioritization and organizational skills; proactive problem identification skills for technical, organizational, and personnel issues; management and resolution of conflicting priorities; and ability to delegate * Comprehensive knowledge and expertise in specification, selection and purchasing equipment systems and materials used for bulk pharmaceutical chemicals, and specialty chemical processing * Stays current with processing related equipment, technology, and innovations through regular reading of trade journals, contact with suppliers, and affiliation with professional organizations * Communication skills across all levels of the organization including: writing reports, proposals, and instructions incorporating both technical and business concepts; conducting briefings, presentations, and technical meetings for internal and external representatives; facilitating operator training, debriefings and problem resolution; providing oral presentations for leadership concerning business needs, project proposals, operations and scheduling of specific phases of projects or contracts; representing Corden in negotiations with outside entities to ensure best terms and conditions * Ability to carry out engineering calculations related to process/equipment design * Knowledge of qualification and validation systems, including test protocols, execution, and reports * Thorough working knowledge and application of QSHE regulatory compliance principles related to chemical and pharmaceutical manufacturing, including FDA, cGMPs, EPA, OSHA, and PSM requirements * Has a working knowledge of business and finance; basic accounting and financial principles (ROI & IRR analysis, cashflow, committed vs. actual costs, etc.) as they apply to project management; demonstrates vision of future business direction and needs; drives results which have major economic impact on the site’s profitability * Knowledge of supporting departments’ procedures and systems, such as purchasing, management of change, and SAP * Understands the impact of the following on the value of a project: life cycle ROI, future processing benefits, financial impacts on the business, regulatory compliance, physical implementation logistics, internal team and corporate approaches, as well as external community needs * Able to generate and implement novel ideas and methods to meet both site and project needs * Ability to analyze situations and anticipate impact of decisions * Skilled at team building, employee involvement, coaching, mentoring, facilitation, and communications both within and external to the department * Ability to lead, direct, and delegate subordinates in individual task areas SALARY Actual pay will be based on your skills and experience. BENEFITS * 401(k) matching - Corden Pharma will contribute 100% of the first 6% - 100% vested after 2 years of service * Accident Plan * Critical Illness Insurance * Dental Insurance * Disability Insurance * Employee Assistance Program * Flexible Spending Account * Health Insurance PPO/HSA * Hospital Indemnity Plan * ID Theft Protection * Life Insurance * Paid Parental Leave * Tuition Reimbursement * Wellness Program * Vacation – Three Weeks 1st Year * Vision Insurance EQUAL OPPORTUNITY EMPLOYER Corden Pharma provides equal employment opportunities to all employees and applicants for employment and prohibits discrimination and harassment of any type without regard to race, color, religion, age, sex, national origin, disability status, genetics, protected veteran status, sexual orientation, gender identity or expression, or any other characteristic protected by federal, state, or local laws. Corden Pharma embraces fair hiring practices. This post will expire December 1, 2025

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Responsibilities

The Project Engineering Group Lead is responsible for providing technical leadership for project engineers and managing capital projects in pharmaceutical development and production. This role includes ensuring project costs, schedules, quality control, and adherence to regulatory laws throughout project life cycles.