SAP SME - Safety, Health and Environmental at CORDEN PHARMA

, Colorado, United States -

Full Time

Start Date

Immediate

Expiry Date

15 Jun, 26

Salary

165000.0

Posted On

17 Mar, 26

Experience

5 year(s) or above

Remote Job

Yes

Telecommute

Yes

Sponsor Visa

Skills

SAP S/4HANA, Safety, Health, Environmental, EH&S Regulations, Business Process Translation, Data Migration, System Authorizations, Acceptance Testing, Training Material Preparation, Cutover Planning, Issue Resolution, System Enhancements, cGMP Compliance, Communication, Planning

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 SAP SME will contribute to the SAP S/4HANA implementation at the Corden Pharma Colorado sites, working both independently and as part of the implementation team, being accountable for all aspects of Safety, Health, and Environmental within the project. The successful candidate will possess in-depth knowledge of EH&S regulations, business processes and practices, and preferably have experience in the Pharmaceutical Industry using SAP software to execute some of those processes. The SAP SME will proactively share expert business knowledge, ensuring the SAP Project Team has sufficient understanding of any business processes, U.S. legal/regulatory compliance and customer requirements that are unique to the Colorado sites of Corden Pharma. The SAP SME will be an active contributor to the SAP S/4 project, capable of raising questions and making key business decisions on behalf of Corden Pharma Colorado Safety, Health, and Environmental. As an ambassador for the company, the SAP SME will personally exhibit behaviors that align with Corden Pharma’s values (Accountability, Collaboration, Integrity, Trust, Reliability) and help to ensure project team members follow company policies and procedures. ESSENTIAL DUTIES AND RESPONSIBILITIES Include the following. Other duties may be assigned. * During the SAP S/4 Project Implementation Project: * Works closely with project team members to ensure successful project delivery * Collaborates with business stakeholders to understand needs and translate into business requirements for the SAP implementation * Describes local business needs and ensures the provided solution is usable/acceptable, ensuring efficient and effective processes * Enthusiastically learns the Corden Pharma global SAP S/4HANA template functionality * Where template functionality does not meet local requirements, ensures business requirements/options/impacts are clearly and thoroughly documented via user stories * In case organizational or procedural changes are required, is responsible to initiate those changes in SME’s organization * Prepares migration data files according to technical requirements – identifies, cleanses, and maps source data to target data * Provides input and makes decisions for system authorizations assigned to SAP S/4 users in area(s) of responsibility * Defines acceptance test criteria and conducts thorough testing of SAP solutions to ensure functionality, stability, and data integrity; identifies and ensures resolution of test issues; gives business approval of test results * Prepares comprehensive training materials for end-users with help from the Corden Roll-out Manager and Implementation Partner Consultant * Actively contributes business aspects to cutover planning and execution * Provides end-user support post go-live/during the hyper care period of the SAP Project * Beyond the SAP S/4 project role, is responsible for: * Issue Resolution: * Is the first point of contact for end-users having process, system, authorization questions or issues * Resolves issues where possible; if unable, ensures issue is raised to the appropriate support team * Supports issue resolution via testing, approving results, updating documentation, training end-users (if applicable), and ensuring timely status updates for end-users and other business stakeholders * System Enhancements: * Gathers local business requirements, identifies business criticality and priority, aligns with fellow SMEs and Global Process Owner(s) * Supports implementation of enhancements, including performing tests, approving results, updating documentation, training end-users, and ensuring timely status updates for business stakeholders throughout the implementation * New SAP Users: * Ensures SAP System authorizations are setup appropriately based on job function * Trains in use of the system and business processes * Business Improvements: * Ensures continuous reviews of business processes, procedures, and practices to identify need for improvements * Aligns improvements with business stakeholders, including other business areas when relevant * Implements business improvements including testing, documentation, and training LEADERSHIP & BUDGET RESPONSIBILITIES Provides input and recommendations. Supports site objectives and plans. SAFETY & ENVIRONMENTAL RESPONSIBILITIES Every individual is personally responsible for the safety and environmental aspects of their 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. QUALITY RESPONSIBILITIES Corden Pharma Colorado (CPC) is a manufacturer of a variety of pharmaceutical products. In following Current Good Manufacturing Practices (cGMP), Corden Pharma Colorado manufactures in accordance with the US Food and Drug Administration (FDA), International Council for Harmonisation Q7 (ICH), and other global regulations as applicable. This is critical as it is our mission to not place patients at risk due to inadequate safety, quality, or efficacy. CPC’s Quality Management System, which incorporates cGMP, is designed to deliver this quality objective. Attainment is produced through the requisite participation and commitment of all staff across departments and at all levels within the company. cGMP is the part of Quality Management System ensuring products are consistently produced to accurate quality standards. Adherence to clearly defined procedures, in compliance with the principles of cGMP, is required when performing operations across Corden Pharma Colorado. 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 from a 4-year college or university or Associates Degree preferred; or 5 years of related experience; or equivalent combination of education and experience. * In-depth knowledge of Pharmaceutical Industry Safety, Health, and Environmental business processes and practices is required. * Experience with SAP ECC or S/4HANA is a plus. * Experience working for a CDMO is a plus. * Experience with Corden Pharma Colorado Safety, Health and Environmental current business processes, practices and use of current systems is a plus. LANGUAGE SKILLS Ability to read, analyze, and interpret general business periodicals, professional journals, technical procedures, or governmental regulations. Ability to write reports, business correspondence, and procedure manuals. Ability to effectively present information and respond to questions from groups of managers, clients, customers, and the general public. MATHEMATICAL SKILLS Ability to work with mathematical concepts such as probability and statistical inference. Ability to apply concepts such as fractions, percentages, ratios, and proportions to practical situations. REASONING ABILITY Ability to solve practical problems and deal with a variety of concrete variables in situations where only limited standardization exists. Ability to interpret a variety of instructions furnished in written, oral, diagram, or schedule form. CERTIFICATES, LICENSES, REGISTRATIONS None. 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 sit; work with hands; and talk or hear. 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 25 pounds. Specific vision abilities required by this job include the 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 moving mechanical parts, 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. * Effective in prioritizing workload * Excellent written and oral communication skills * Computer skills with intermediate ability to use Microsoft Office Suite and SAP within the modules needed to complete essential functions * Strong planning, implementation, and follow-up skills * Good facilitation skills and ability to interact with colleagues from all levels of the organization 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 April 27, 2026

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Responsibilities

The SAP SME will be accountable for all aspects of Safety, Health, and Environmental during the SAP S/4HANA implementation at Corden Pharma Colorado sites, collaborating with stakeholders to translate local needs into SAP requirements. Post-implementation, the role involves ongoing issue resolution, managing system enhancements, training new users, and driving continuous business process improvements.