Program manager jobs in Puerto Rico

The Chemistry, Manufacturing and Controls (CMC) Global Regulatory Affairs (GRA) professional is responsible for developing and executing global regulatory strategies for CMC aspects of small molecule products during late-stage development and throughout the commercial lifecycle. This includes initial marketing application, post-approval changes, and lifecycle management activities across multiple regions. Primary regions/markets of responsibility include US and secondarily EU and Canada for smooth, timely approvals or continued marketing. This position requires approximately 20% domestic/international travel. **** + Develop and implement global CMC regulatory strategies for late-stage development, marketing applications (e.g., NDA/MAA), and post-approval lifecycle activities (supplements, renewals, variations) around small molecule drug substance, drug products and drug-device combination products. Ensure compliance with global regulations (FDA, EMA, ICH, WHO) and anticipate regulatory changes impacting CMC requirements. + Plan, prepare, and review CMC sections of regulatory submissions (IND/IMPD/NDA/MAA, post-approval supplements). Determine regulatory CMC content and scientific/technical requirements to ensure documentation meets regulatory standards. Lead responses to Health Authority questions and deficiency letters. + Represents CMC RA in project team meetings and provides expert interpretation of regulatory guidelines and perspective to the cross-functional team. Serve as CMC regulatory lead on global project teams (Pharmaceutical Development, Quality, Manufacturing, Global Regulatory Strategy). + Assess and provide regulatory strategy for CMC technical changes, process improvements, and new product introductions. Develop CMC strategies for post-approval changes, line extensions, and global harmonization of product registrations. Monitor and implement regulatory updates impacting marketed products. + Represent the company in meetings and negotiations with global Health Authorities for CMC related matters. Prepare briefing packages and lead CMC discussions during regulatory interactions as required during late-stage product development as well as post approval changes. + Support departmental initiatives such as preparing/updating departmental job procedures. Help assess and develop innovative ideas to optimize local and global CMC RA departmental processes and improve efficiencies, addressing current and future challenges. + Experience in CPP application filing through eCATS, 510(j)(3) reporting through next Gen portals is a plus. + Develop and maintain collaborative relationships with other local and/or global functional units [OPC CMC Global Regulatory Affairs, Global Regulatory Strategy, Manufacturing facilities, Global Quality, Technical Operations, Business Development etc.] as well as affiliates, external partner companies, contract manufacturers, packagers and suppliers etc. + Be proficient in the tools and systems needed for the function including and not limited to CREDO (document management), PRISM (regulatory information management system), Global Trackwise, eCTS Viewer (Viewer), Adobe Acrobat, and Microsoft Office tools. + Performs other duties as assigned related to CMC RA function. **Qualifications** **Education** : + BS/MS/PhD in Chemistry, Pharmacy, or related scientific discipline. + RAC certification will be a plus. **Experience** : + 7+ years in Regulatory Affairs CMC, with significant experience in small molecules is required. The ideal candidate will also have some prior experience with biologic, peptide or oligonucleotide products. + Proven track record in late-stage development investigational filings, marketing applications (NDA/MAA), global submissions, and post-marketing lifecycle management as the CMC Regulatory lead. + Regulatory experience in handling-controlled substance applications will be a plus. **Skills:** + Comprehensive knowledge of drug development process, pharmaceutical technology, drug manufacturing processes, analytical/quality control, GMP and related issues. + Knowledge of CMC regulatory requirements for small molecules during late stage development, initial marketing application and post-approval. + Comprehensive knowledge and experience in preparing CMC (Quality) sections for investigational, marketed product submissions (IND/IMPD/NDA/MAA/DMF, post-approval supplements) for FDA and equivalent submissions for Europe and Canada. + Comprehensive understanding of the global regulatory environment. + Strong analytical, problem solving, organizational and negotiation skills. Strong ability to work in a matrix environment and across cultural lines. + Strong leadership, communication, and negotiation skills. + Ability to manage complex projects and timelines across multiple regions. + Computer skills with demonstrated experience in working with the Microsoft suite of programs (Word, Excel, PowerPoint, and Outlook). + CMC reviewer (assessor) with FDA or EMA will be a plus. **Competencies** **Accountability for Results -** Stay focused on key strategic objectives, be accountable for high standards of performance, and take an active role in leading change. **Strategic Thinking & Problem Solving -** Make decisions considering the long-term impact to customers, patients, employees, and the business. **Patient & Customer Centricity -** Maintain an ongoing focus on the needs of our customers and/or key stakeholders. **Impactful Communication -** Communicate with logic, clarity, and respect. Influence at all levels to achieve the best results for Otsuka. **Respectful Collaboration -** Seek and value others' perspectives and strive for diverse partnerships to enhance work toward common goals. **Empowered Development -** Play an active role in professional development as a business imperative. Minimum $146,955.00 - Maximum $219,650.00, plus incentive opportunity: The range shown represents a typical pay range or starting pay for individuals who are hired in the role to perform in the United States. Other elements may be used to determine actual pay such as the candidate's job experience, specific skills, and comparison to internal incumbents currently in role. Typically, actual pay will be positioned within the established range, rather than at its minimum or maximum. This information is provided to applicants in accordance with states and local laws. **Application Deadline** : This will be posted for a minimum of 5 business days. **Company benefits:** Comprehensive medical, dental, vision, prescription drug coverage, company provided basic life, accidental death & dismemberment, short-term and long-term disability insurance, tuition reimbursement, student loan assistance, a generous 401(k) match, flexible time off, paid holidays, and paid leave programs as well as other company provided benefits. Come discover more about Otsuka and our benefit offerings; ********************************************* . **Disclaimer:** This job description is intended to describe the general nature and level of the work being performed by the people assigned to this position. It is not intended to include every job duty and responsibility specific to the position. Otsuka reserves the right to amend and change responsibilities to meet business and organizational needs as necessary. Otsuka is an equal opportunity employer. All qualified applicants are encouraged to apply and will be given consideration for employment without regard to race, color, sex, gender identity or gender expression, sexual orientation, age, disability, religion, national origin, veteran status, marital status, or any other legally protected characteristic. If you are a qualified individual with a disability or a disabled veteran, you may request a reasonable accommodation, if you are unable or limited in your ability to apply to this job opening as a result of your disability. You can request reasonable accommodations by contacting Accommodation Request (EEAccommodations@otsuka-us.com) . **Statement Regarding Job Recruiting Fraud Scams** At Otsuka we take security and protection of your personal information very seriously. Please be aware individuals may approach you and falsely present themselves as our employees or representatives. They may use this false pretense to try to gain access to your personal information or acquire money from you by offering fictitious employment opportunities purportedly on our behalf. Please understand, Otsuka will **never** ask for financial information of any kind or for payment of money during the job application process. We do not require any financial, credit card or bank account information and/or any payment of any kind to be considered for employment. We will also not offer you money to buy equipment, software, or for any other purpose during the job application process. If you are being asked to pay or offered money for equipment fees or some other application processing fee, even if claimed you will be reimbursed, this is not Otsuka. These claims are fraudulent and you are strongly advised to exercise caution when you receive such an offer of employment. Otsuka will also never ask you to download a third-party application in order to communicate about a legitimate job opportunity. Scammers may also send offers or claims from a fake email address or from Yahoo, Gmail, Hotmail, etc, and not from an official Otsuka email address. Please take extra caution while examining such an email address, as the scammers may misspell an official Otsuka email address and use a slightly modified version duplicating letters. To ensure that you are communicating about a legitimate job opportunity at Otsuka, please only deal directly with Otsuka through its official Otsuka Career website ******************************************************* . Otsuka will not be held liable or responsible for any claims, losses, damages or expenses resulting from job recruiting scams. If you suspect a position is fraudulent, please contact Otsuka's call center at: ************. If you believe you are the victim of fraud resulting from a job recruiting scam, please contact the FBI through the Internet Crime Complaint Center at: ******************* , or your local authorities. Otsuka America Pharmaceutical Inc., Otsuka Pharmaceutical Development & Commercialization, Inc., and Otsuka Precision Health, Inc. ("Otsuka") does not accept unsolicited assistance from search firms for employment opportunities. All CVs/resumes submitted by search firms to any Otsuka employee directly or through Otsuka's application portal without a valid written search agreement in place for the position will be considered Otsuka's sole property. No fee will be paid if a candidate is hired by Otsuka as a result of an agency referral where no pre-existing agreement is in place. Where agency agreements are in place, introductions are position specific. Please, no phone calls or emails.

City/Cities: Cidra Travel Required: 00% - 25% No Shift: Plans and coordinates activities to ensure Company project goals are accomplished within defined scope, time, and cost constraints. Project Manager provides leadership and executes strategy for Engineering Projects efforts in support of plant's strategic and production plans. He/she leads short-term and long-term capital projects, along with day-to-day Plant Engineering and Financial activities and team/suppliers' management. Function Related Activities/Key Responsibilities: Strategic Planning and Capital Project Leadership Lead the planning, execution, and delivery of strategic capital projects in alignment with the company's strategic plan, budget, timelines, and quality standards. Participate in strategic master planning and the definition of new technology projects aligned with CPS Global strategy. Actively contribute to the CapEx Projects Justification process and serve as a key collaborator of the Capital Review Committee (CRC). Project Execution and Delivery Develop and manage project scopes, schedules, milestones, and deliverables from initiation to commissioning. Coordinate and supervise internal teams and contractors, ensuring compliance with contractual, safety, environmental, and regulatory requirements. Oversee contractor performance, ensuring adherence to environmental, safety, ergonomic, and efficiency standards. Conduct bidding analysis and contractor selection for CapEx projects, managing execution and quality throughout. Ensure change management processes are followed for project specification modifications. Communication, Reporting and Stakeholder Management Maintain effective and consistent communication with internal customers, contractors, and regulatory agencies. Prepare and present regular status updates, performance metrics, and financial projections to management and stakeholders. Ensure comprehensive documentation of project progress, decisions, and contractual matters. Financial and Resource Management Manage project budgets, track expenditures, and identify budget deviations, escalating where necessary for strategic decisions. Administer the capitalization process for assets purchased through capital funds. Support monthly, quarterly, and annual financial reporting, including carryover and RFA (Request for Authorization) processes related to funding adjustments. Compliance, Quality, and Risk Management Ensure all projects comply with applicable design codes, company standards, internal controls, environmental regulations, and legal requirements. Integrate environmental performance indicators (air emissions, water consumption, energy efficiency) into project design, contractor selection, and evaluations. Develop and enforce quality assurance plans, direct testing activities, and ensure accurate maintenance of project drawings and technical documentation. Identify and mitigate project risks, ensuring issues are escalated promptly with proposed solutions. Technical and Engineering Support Provide engineering consulting to other units, supporting current and future capital project needs. Design, test, and procure specialized process equipment unique to the concentrate manufacturing business. Ensure drafting resources maintain accurate, updated technical drawings with proper version control. Develop and implement business processes to ensure projects meet all functional and technical requirements. People Leadership and Development Coordinate the recruitment and allocation of internal and external project resources. Provide training to new associates and contractors on company procedures, safety, and environmental standards relevant to assigned projects. Foster collaboration, accountability, and continuous improvement among project teams and stakeholders. Participate in the Vertical Start Up of each Strategic project under his/her scope. Education Requirements: Architecture, Civil, Industrial, Mechanical or Electrical. Chemical Engineer, of Foods, or similar graduation. Fluent in English & Spanish Related Work Experience: Desirable Experience of minimum 7 years in the position or similar function as: Operations Manager Management of multi-disciplinary technical / engineering teams. Proven experience in the installation and commissioning of filling lines within an industrial manufacturing environment. Major Capital Projects (specification, design, installation, commissioning, cost control, purchasing, contract, planning, risk analysis & avoidance). Communications Skills: Fluent English and Spanish verbal and written Effective written and oral communication with cross-functional teams and management Effectively communicates and influences non-technical senior managers. Strong interpersonal and communication skills and the ability to work effectively with a diverse community Functional Skills: Project Management Business Excellence Lean Manufacturing Change Management Structured Problem Solving Skills: Change Management, Project Management Improvement, Stakeholder Management, Waterfall Model Our Purpose and Growth Culture: We are taking deliberate action to nurture an inclusive culture that is grounded in our company purpose, to refresh the world and make a difference. We act with a growth mindset, take an expansive approach to what's possible and believe in continuous learning to improve our business and ourselves. We focus on four key behaviors - curious, empowered, inclusive and agile - and value how we work as much as what we achieve. We believe that our culture is one of the reasons our company continues to thrive after 130+ years. Visit Our Purpose and Vision to learn more about these behaviors and how you can bring them to life in your next role at Coca-Cola.

LUMA - Built for Puerto Rico We rely on electricity every day. We need it to run our appliances, power the streetlights and produce the goods and services that drive our economy. At LUMA we are committed to provide Puerto Rico with electricity that we all can depend on. At LUMA, we put people first - our employees, our customers and the communities where we live and work. We encourage and inspire our people to embrace opportunities as they work to build an electricity system that will make Puerto Rico a better place. If you're looking for a career where you can make a tangible difference in the lives of your neighbors and your community, LUMA is the place for you. LUMA offers new jobs designed to respond to the current and future needs of the T&D system. Together we're transforming the island's electric transmission and distribution system, and energizing Puerto Rico. Please note that these new jobs with LUMA offer different terms and conditions of employment to those currently in place with PREPA. We will schedule interviews with all qualified PREPA candidates. All PREPA applicants will receive priority in hiring and a compensation package equal to or better than what they receive today. In order to receive notifications as additional positions and locations are posted, please create a profile on our career site. About the Position Reporting to Manager, Distribution Projects, is responsible for the overall project planning, organizing, management, coordination and administration of capital project work for distribution level substation and line work in order to achieve project completion on budget, on time, as per agreed scope and with proper risk and quality management. This position supports LUMA through the planning and delivery of project work through all phases of new capital projects and is responsible for the effective planning and delivery of all phases of project. What will you get up to everyday? Responsible for monitoring, tracking of schedules, costs, risks and quality, supervising and reporting on project deliverables including external contractors. Responsible for managing interfaces with contractors during construction and ensure that all Project deliverables are completed. Ensure contract policies and practices are followed to ensure the company achieves the accepted intent of agreements, have methods to manage change/exceptions and properly protects the company from failure risks. Effectively communicate with appropriate internal and external groups including Municipal, State and Federal agencies, Indigenous Groups, contractors. Provide daily direction and mentorship to Project Coordinators to ensure that PMO Processes, Procedures, Quality Assurance and inspection programs are being adhered to. Lead and monitor the construction of all assigned projects for scope, schedule and cost changes and report on changes that can impact the project and provide advice on course of action to maintain the schedule within authority levels or escalate to quickly address. Excellent, organizational, communication, interpersonal and leadership skills. Expert knowledge in Project Controls scheduling, tasks development, WBS, Costs, Estimating, Risks and Reporting (to Regulatory and Federal Aid Agencies). Supervisory skills relating to site management of multiple work groups and contractors. Proven skills in Project Execution and Contractor Management. Perform other duties as assigned. Perform major storm restoration work and associated drills as assigned. Follow all policies and procedures. What We are Hoping You Bring to LUMA LUMA's culture is rooted in the concept of People First, Safety Always. We want your knowledge and expertise to pair with LUMA's globally recognized experts in numerous fields such as customer service, field workforce development, high-voltage transmission engineering, distributed energy resources and mini/micro grid integration. Our employees receive substantial training and development, as well as opportunities for advancement and success. Within our People First, Safety Always culture, we're committed to offering continuous learning opportunities and career-long support for our employees. Education Bachelor of Science, Engineering, Business, or technical institute Project management Professional (PMP or PgMP) training and experience would be considered an asset. Experience Minimum of 5 years experience in a large electrical utility environment with knowledge in design, construction, and commissioning of electric utility systems, equipment and components. Experienced with working on Regulated Utilities and managing project interfaces with Regulatory Commission and Independent System Operators, International Aid Agency Interfaces on Large Utility Scale. Licenses/Certifications Valid Driver's License. More Details on what to expect with this position at LUMA space Travel Requirements 30% Physical Demands Stationary Position: Constantly Pushing/ Pulling/ Reaching: N/A Climb: N/A Kneel: Seldom Grab: Seldom Bend: Seldom Lift/ Carry over: 31-50 LBS Vision: 20/20 Corrected Vision Hearing: Receive detailed information if spoken to. Working Conditions Wet or humid: Seldom Working near or on moving mechanical parts: Seldom Working near or on heavy machinery: Seldom Working in high places: Seldom Exposed to fumes or airborne particles: Seldom Exposed to toxic or caustic chemicals: Seldom Frequency of working in outdoor weather conditions: Seldom Work with electricity: Seldom Work with explosives: N/A Work on or near a source of radiation: N/A Loud Noise conditions (abover 87 db): Seldom Other environmental factors including weather conditions: N/A Other: We are looking forward to seeing your application! You made it to the end of the job posting! Thank you for expressing interest in LUMA and taking the time to read all the details of this position. We encourage you to apply and give us the opportunity to get to know you better through the recruitment process. Together, we're energizing the people of Puerto Rico. Note: this job description is not designed to cover or contain a comprehensive listing of activities, duties or responsibilities that are required of the employee. Duties, responsibilities, working conditions, physical demands, and activities may change or new ones may be assigned at any time with or without notice. LUMA 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. This policy applies to all terms and conditions of employment, including recruiting, hiring, placement, promotion, termination, layoff, recall, transfer, leaves of absence, compensation and training.

Job DescriptionSalary: Were looking for a sharp, detail-obsessed Project Manager to lead the charge on campaigns that span creative, digital, media, and experiential. Youll be the nerve center of the operation planning, tracking, coordinating, and keeping projects on time, on brief, and on budget. If youre the kind of person who thrives on structure, loves solving problems before they surface, and can turn a tangle of tasks into a seamless flow this role is made for you. What Youll Do Lead end-to-end project management across a range of clients and campaign types Define scopes, build timelines, allocate resources, and monitor progress daily Manage budgets in collaboration with accounts, vendors, and internal teams ensuring every dollar is tracked, justified, and optimized Create and maintain detailed project documentation (budgets, schedules, task boards) Ensure deliverables meet deadlines, brand standards, and client expectations Track feedback, approvals, and revisions across departments Communicate clearly with creatives, strategists, media buyers, production vendors, and clients Anticipate roadblocks and proactively resolve issues to keep momentum Contribute to process improvements that boost efficiency and clarity across the agency What You Bring 24 years experience in a project management role, ideally within a marketing or creative agency Demonstrated experience managing campaign budgets, vendor quotes, and reconciliations Mastery of tools like ClickUp, Notion, Google Suite and you're not afraid to customize them Fluent in English and Spanish, written and verbal Calm under pressure with a solutions-first mindset Meticulous attention to detail and timeline discipline Strong interpersonal skills youre the teams go-to for clarity and accountability Comfort working across multiple projects and clients simultaneously Bonus Points Familiarity with production workflows (photo/video shoots, print, OOH) Experience managing public sector/government projects Understanding of media flowcharts, campaign pacing, and vendor coordination Project Management certifications (PMP, Agile, etc.) At SUP3RNOVA, we move fast, think bold, and build with precision. If you're ready to be the operational anchor in a sea of creative ambition, lets connect.

Treasury Project Manager (Non-IT) - Contract Opportunity A leading financial services institution is seeking an experienced Treasury Project Manager to support initiatives within derivatives operations, collateral management, and regulatory compliance. This role will lead cross-functional projects that enhance treasury processes, strengthen risk controls, and improve operational efficiency. Key Responsibilities * Lead and manage treasury- and derivatives-focused projects from initiation through delivery using Agile and/or Waterfall methodologies. * Drive initiatives related to collateral management, margining, derivatives operations, and compliance with regulatory frameworks such as Uncleared Margin Rules (UMR). * Collaborate with teams across Risk, Operations, Technology, and Compliance to gather requirements, define scope, and ensure alignment with business objectives. * Coordinate with external vendors and third-party partners on integrations, timelines, testing, and issue resolution. * Facilitate project governance, including meetings, progress updates, documentation, and communication plans for stakeholders and leadership. * Identify project risks, establish mitigation plans, and maintain strong project discipline. * Support enhancements, workflow improvements, and process changes related to the Calypso platform and associated collateral/derivatives functions. Preferred Qualifications * Background in derivatives operations, risk management, or regulatory compliance. * Strong understanding of UMR, derivatives regulations, and collateral management practices. * Proficiency in project management methodologies and tools (Agile/Waterfall). * Experience working with the Calypso system for derivatives and collateral management. * Excellent communication, coordination, and stakeholder management skills, including experience engaging with external vendors. Additional Details * Contract Duration: 6 months * Start Date: Early to mid-January (can start early if available) * Candidates should be open to periodic on-site meetings as needed.

We are looking for a dynamic and resourceful Project Manager to assist with the successful completion of construction and preventive/proactive maintenance of projects in our Facilities. These may include large-scale capital projects, major remodels, or smaller endeavors. The selected candidate will oversee facilities projects deployment & implementation of work plans while assuming the sole responsibility of the execution of the same while minimizing the clients responsibility. Must also assure the optimum service, minimizing change orders through precise execution & planning that contemplates mitigation and fast problem resolution. Supervises staff/crews of 5 to 20 employees whilst overseeing and assuring safety and security standards are followed all the time. In a nutshell- the ideal candidate would have total control over the project's deployment & execution focusing on preventing changes, obtaining optimum results, controlling budget expenses, avoiding schedule changes, and saving time being the key controller of the project. Responsibilities: Proficient in Microsoft Office Suite and eProject or similar project management tools (preferred). Bilingual- English & Spanish- complete proficiency wrote as spoken. Experience working with capital projection and budget. Precise knowledge of all the documentation and process required for changes, modifications & certifications for all project phases. Well acquainted with Safety & Security Practices Being strongly self-confident with an analytical mindset, plus having the capability of achieving customer satisfaction by understanding the clients needs is a must to succeed in this role. Exceptional managerial & supervising skills that promote teamwork commitment and discretionary effort. Good ability for handling pressure at critical times and execute tasks effectively. Willingness to do what is needed to ensure deadlines are met. Needs to be a fast learner for hitting the ground running on new projects. Resourceful and self-starter who enjoys challenges. Proficiency in both technical and business letter writing etiquette. Knowledge of HVAC & Plumbing systems, building products, construction details/design, and relevant rules, regulations, and quality standards. Requirements Bachelor's degree in engineering, architecture, project manager, or related area Construction Experience at least 1to 3 years Project Management Experience (commercial and/or industrial facilities) at least 1 to 3 years

We're looking for a collaborative, detail-oriented project manager to lead cross-functional initiatives that support our legal and healthcare operations. The ideal candidate is experienced in managing technology-driven projects and excels at coordination, communication, and execution. Key Responsibilities Project Management · Lead and manage operational and IT-related projects from planning through delivery. · Define project scope, timelines, and milestones aligned with business goals. · Track project progress, resolve issues, and communicate updates to stakeholders. · Coordinate tasks across multiple teams to ensure smooth delivery. Stakeholder Communication · Act as a liaison between internal teams, clients, and vendors. · Facilitate regular check-ins, document decisions, and keep everyone aligned. · Support client onboarding and ensure expectations are met throughout the project lifecycle. Process Improvement · Identify opportunities to streamline workflows and improve documentation. · Implement proper project tracking and reporting practices. · Support the team by removing blockers and enabling progress. Technology Coordination · Collaborate with IT and development teams to implement business solutions. · Ensure documentation, training, and support materials are created and shared. · Support integration efforts with external platforms such as EHR/EMR or legal case management tools. Required: · 3+ years of experience managing projects in legal, healthcare, or tech settings. · Strong understanding of project management practices (Agile, Waterfall, or Hybrid). · Comfortable coordinating cross-functional teams and communicating with stakeholders. · Basic understanding of HIPAA and data privacy concepts. Preferred: · Bachelor's degree in Business, IT, Health Information Management, or related field. · Project Management certification (PMP, CAPM, or similar) is a plus. · Exposure to data integrations or process automation is helpful but not required. Please send your resume in English

Job DescriptionSalary: Want to be part of a transformative team? This job is for you! The CSV Account & Project Manager is responsible for managing client accounts, developing new business opportunities, and overseeing project execution for Moriahs services. This role combines technical project leadership with client service excellence, ensuring projects are delivered on time, on budget, and in compliance with all applicable standards, particularly in regulated industries such as pharmaceuticals and medical devices. Responsibilities Serve as primary point of contact for assigned clients, maintaining strong, long-term relationships. Identify areas of service (sales) opportunity & develop proposal. Supervise, coach and lead the department team for overall projects and department objectives. Coordinate with Project Lead Coordinators to manage timelines, deliverables, and resources. Partner with upper management to develop strategies for business development growth. Identify areas of opportunity to expand services and support proposal development. Act as technical consultant for automation and CSV solutions, providing strategic recommendations to clients. Lead and supervise cross-functional project teams in planning and execution. Promote team engagement, accountability, and high performance throughout project execution. Conduct performance evaluations, one-on-one meetings, and approve PTO. Ensure that all projects meet compliance standards (e.g., FDA, GMP) and client expectations. Maintain strong internal communication with operations and leadership teams. Qualifications Bachelors Degree Engineering, science or related field. Ability to plan, manage and execute complex project activities to a successful conclusion with little or no oversight. 5+ years of experience in engineering consulting, project management, and CSV executionroles. Proven experience in account management, sales, or consultative sales within technical or regulated industries. Experience with network and system administration of Microsoft based systems, Visual Studio, ASP.Net and SQL is preferred. Demonstrated successful communication and negotiation skills in order to manage conflicting and/or multiple demands, including ability to present to various level within an organization. Demonstrated ability to apply analytical skills to identify problems; recognizes symptoms, causes, and alternate solutions and makes timely sound decisions even under risk and uncertainty. Strong understanding of automation systems, PLCs, CSV, and related validation frameworks. Proven track record in business development within the pharmaceutical or regulated industries. Skilled in managing multiple projects, teams, and priorities in parallel. Proficiency in project management and CRM software. Bilingual (Spanish and English) preferred. Physical/Manufacturing Requirements Office and plant environment. Able to climb/ ladders/steps Able to lift items 25 lbs Keyboarding, lifting, standing, bending, walking. Travel or Environment Requirements Adhere to safe work practices Some travel (including international) required (Approx. 5% of time) We are an equal opportunity employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability, protected veteran status, or any other characteristic protected by applicable law.

Company: Island Finance With over 65 years of service, Island Finance LLC is the largest financial institution in Puerto Rico. It serves over 70,000 clients, with consumer loans and a variety of financial products and services. Also, it has a comprehensive distribution network with 48 branches, a call center, and an advanced Internet banking service available through ********************** Island Finance is not only a Financial Company committed to the future of Puerto Rico, but also works every day to offer the highest quality of service and is the one who has reached out to thousands of clients when they have needed it most, in addition to maintaining a positive and dynamic work environment with a team committed to offering the best. We are the Financial Company of the 21st century, with over five decades helping you realize your dreams. Because there is one thing that does not change, and that is that sixty-five years later we are here... We deeply appreciate your support and reaffirm our commitment. That's why with us... ¡¡Yes, you can!! General Job Summary The Project Manager will lead, initiate, and manage company business projects and guide highly competent teams to achieve successful project implementation. PM will use the Project Management Methodology to initiate, plan, design, execute, monitor, control, and close projects. You will manage risks, including making decisions to reduce uncertainty. Serve as a point of contact and liaison between internal team members or SME's, external clients, IT partners, and suppliers. Monitor progress to ensure deadlines, requirements, and cost targets are met. Bring technical literacy, savvy, and knowledge to bear, with a keen eye for detail and strong project management organization. Essential Function and Responsibilities Defining the project scope, objectives, and creating a detailed plan that includes timelines, resources, and potential risks Building and leading a cohesive team, assigning tasks, and ensuring effective collaboration among team members Communication: Acting as a bridge between the team and stakeholders, maintaining transparent and consistent communication to keep everyone informed Identifying potential risks early on and developing strategies to mitigate them. Ensuring the project stays within budget by monitoring expenses and making necessary adjustments Tracking the project's progress, generating reports, and making necessary adjustments to keep the project on track. Closing Projects: Finalizing all project activities, ensuring all deliverables are met, and conducting post-project evaluations to identify lessons learned. Need to ensure that the project adheres to relevant laws, regulations, and standards. Support in the development of documentation applicable to the processes once the project is put into production (forms for the development of the service, procedures, contingency procedures, manuals, among others). Generate a Project Charter of the projects according to the established time and results objectives (technical, operational, and return on investment), for the final approval of the senior management, as required. Manage contracts with vendors and suppliers by assigning tasks and communicating the expected deliverables. Requirements Bachelor's degree in project management, business, computer science, industrial engineering, or related areas required. Knowledge of developing and working with schedules in Microsoft Project or similar tools Project Management Professional (PMP) certification preferred Minimum of two (2) years' project management experience required. Three (3) years of management experience is preferred. Advanced knowledge of developing and working with schedules in Microsoft Project Fully Bilingual (oral and written) Excellent analytical ability, critical thinking, organizational, problem-solving, and consulting skills Being flexible and able to adjust plans as needed in response to changes. Knowledge in Critical Path Analysis, Cost and Resource Management, and Project Controls. High level of commitment, initiative, and self-motivation Strong, effective communication skills (verbal and written). Managing and resolving conflicts within the team or with stakeholders Ability to prioritize, work to deadlines, and work under pressure. Results-oriented, flexible, adaptable. Work well independently and be a team player. Versatile, creative temperament, ability to think outside the box while defining sound and practical solutions. Island Finance is an Equal Opportunity Employer Learn more about us at Island Finance and keep updated with our latest job postings at Island Finance Empleos Connect with us! Linkdnl | Facebook

For Project Management services. WHAT MAKES YOU A FIT: The Technical Part: Bachelor of Science in Engineering and at least five (5) years of experience in Project Management within the Pharmaceutical Industry. Shift: Administrative and according to business needs. Bilingual: English and Spanish (verbal/written). Experience in: Project Management life cycle: Scope of Work, Cost Estimate, procurement, bidding process, scheduling, project control, contractor supervision, and start-up. Understanding of pharmaceutical manufacturing processes, regulations, and industry best practices. The Personality Part: Our Next Piece is someone who treats everyone they meet like family, especially our resources, clients, and team members. In other words, being a customer service pro is one of your (many) talents. Being the Piece means you're full of bright ideas and eager to innovate, always bringing top-quality results to the table. Are you ready to Be The Piece? AS A PIECE OF FITS, YOU WILL: (The day-to-day on the job) Manage all aspects of project(s): planning, implementation, monitoring, completion, and follow-up. Manage competing timelines and prioritize critical tasks. Establish and achieve project standards for work quality and quantity. Assess project issues and develop solutions to meet scientific, productivity, quality, and client satisfaction goals and objectives. Assist in technical, financial, and organizational issues by researching issues, providing recommendations, and maintaining document archives. Maintain and track project budget(s). Reconcile the use of resources for the projects. Identify and anticipate schedule slips or changes and analyze the costs and resource impact. Implement tools, techniques, and processes to provide or create information to enable informed decision-making within the teams. Actively participate in directing the evolution and defining the role of the project. Ensure the project goals and objectives are well understood by the various functional areas. Liaison with department staff, sub or satellite team leaders, and members to obtain their continued input and feedback on the benefits, needs, and issues associated with the project. Maintain the master project plan and schedule for assigned projects. Recommend and develop operational or process improvements for the performance and successful functioning of the project team. Provide department management with project management support on an as-needed basis, as well as for special projects. Complete and keep up to date with the training required for the position. Ensuring all activity and documentation is in compliance with the guidelines and procedures that regulate the pharmaceutical industry. WHO WE ARE: We are a Service Provider company different from the rest. We pride ourselves in how we treat the most important piece of our company's puzzle: you! We integrate Engineering, Construction, Maintenance, Utilities and Specialized Technical services across the Island (and in the US as well!). Our company is flexible, family-oriented and focused on our resources' well-being, while providing our Pharmaceutical, Medical Device and Manufacturing industry clients with top-notch quality talent. We're FITS! Are you the Next Piece?

Validation & Engineering Group, Inc. (V&EG) is a leading services supplier provides solutions for the Pharmaceutical, Biotechnology, Chemical, Food, and Medical Devices industries in the following areas: Laboratory, Compliance, Computer, Engineering, Project Management, Validation, and other services. We are seeking for talented, dedicated individuals who are committed to work under the highest standards of ethics to and with expertise in the following areas: * Validation Project Manager * Verify and facilitate actions for the New Laboratory Construction Schedule and the Validation Plan to flow in a coordinated way. * Overseeing the successful completion of projects assuring Mechanical Completion is achieved. * Managing relevant activities, facilitating the removal of road-blocks, setting deadlines, communicating with company executives about the state of the project, ensuring projects stay on track and on budget, and adjusting if necessary to meet new requirements. * The PM will develop the Validation Master Plan and lead the Risk Assessment exercise. * Manage that all Qualification activities are completed on time * Serving as a point of contact for teams when multiple units are assigned to the same project to ensure team actions remain in synergy * Communicating with executives or the board to keep the project aligned with their goals * Adjusting schedules and targets on the project as needed Skills & Qualifications * Understanding of the Project Management Institute (PMI) framework * Knowledge of various project management methodologies * Proven leadership skills * Cost and risk management skills * Excellent communication, interpersonal and negotiation skills * Problem-solving skills * Ability to delegate effectively * Time management skills * Friendly and approachable Education and Training Requirements: A minimum of 8 years experience and a bachelors degree in either sciences, including engineering or management is required.

Provides critical support in developing global regulatory strategy, planning and execution of global investigational and marketed prescription drug submissions and manages lifecycle activities for all assigned projects in alignment with the Global Regulatory Lead. Translates complex pertinent global requirements and provides an assessment of the associated regulatory challenges to the GRL, global regulatory team, assigned project teams, and internal/external functional business units as needed. Works collaboratively with members of the global regulatory team to develop global regulatory plans, address global regulatory issues, health authority queries, and regulatory obligations. **J** **ob Responsibilities** - Provides critical support in developing global regulatory strategy, planning and execution of global investigational and marketed prescription drug submissions and manages lifecycle regulatory activities in alignment with the Global Regulatory Lead (GRL). - Identifies the need and obtains regulatory intelligence, researches precedent approvals and prior health authority decisions to assess applicability to support development of strategic options for assigned Otsuka products. - Translates complex pertinent global requirements and provides an assessment of the associated regulatory challenges to the GRL, global regulatory team, assigned project teams, and internal/external functional business units as needed. - Works collaboratively with members of the global regulatory team (GRL, regional leads, CMC-RA, labeling, medical writing, regulatory operations, etc.) to develop global regulatory plans, address global regulatory issues, health authority queries, and regulatory obligations. - Authors, coordinates, reviews, and executes submissions and responses to regulatory authorities related to INDs, amendments, supplements, aggregate reports, NDAs (as applicable) within company timelines and in accordance with regulations and guidelines. - Independently manages preparation of INDs, CTAs, amendments, supplements, and aggregate reports within company timelines and in accordance with regulations and guidelines. - Confirms submission documents are accurate, compliant, and high-quality to allow for smooth and expeditious approvals from regulatory authorities. - Serves as the sponsor point of contact to the health authority. - Represents GRA in project team meetings and provides regulatory guidance and perspective to the cross-functional team in conjunction with GRL, to determine appropriate actions to meet timelines and/or resolve issues. - Effectively manages and directs internal support staff and external consultants for assigned projects. - Interacts effectively with internal/external functional business units to gather data and develop documentation required for on-time submissions. - Works closely with GRA department to execute departmental initiatives to improve overall efficiency, quality, and/or output. - Assess and develop innovative ideas to move GRA department to address current and future challenges. **K** **nowledge, Skills, and Competencies** **K** **nowledge** - Experience working in the pharmaceutical and/or healthcare industry. - Knowledge and experience with preparation of global regulatory submissions (IND, CTA, NDA or BLA, MAA). - RAC certification a plus. **Skills** - Strong oral and written communication skills. - Solid working knowledge and understanding of the drug development process, laws, regulations, and guidelines including FDA, ICH, etc. - Able to successfully interpret and apply regulatory intelligence to work output. - Ability to lead teams, prioritized work, proactively manage and communicate issues, scopes progress and risks throughout the project lifecycle ensuring key stakeholders are informed. - Able to establish close communications and working relationship with cross functional teams to meet business objectives. Results-oriented, entrepreneurial, and self-motivated with excellent organizational skills with ability to learn and grow. - Strong demonstrated experience with Microsoft Office programs (Word, Excel, PowerPoint, Outlook) and familiarity with electronic document management systems (EDMS). **Competencies** See OPDC Competencies Chart (Level X) **P** **hysical Demands and Work Environment** Travel (approximately 20%) See document Physical Demands and Work environment for further requirements. **Education and Related Experience** Bachelor's degree with 5+ years' experience or Master's degree with 2 years' experience in regulatory affairs or related areas (e.g., clinical development, project management, quality assurance, etc.) in pharmaceutical or healthcare related industry. Experience with FDA or other health authority interactions desirable. **Competencies** **Accountability for Results -** Stay focused on key strategic objectives, be accountable for high standards of performance, and take an active role in leading change. **Strategic Thinking & Problem Solving -** Make decisions considering the long-term impact to customers, patients, employees, and the business. **Patient & Customer Centricity -** Maintain an ongoing focus on the needs of our customers and/or key stakeholders. **Impactful Communication -** Communicate with logic, clarity, and respect. Influence at all levels to achieve the best results for Otsuka. **Respectful Collaboration -** Seek and value others' perspectives and strive for diverse partnerships to enhance work toward common goals. **Empowered Development -** Play an active role in professional development as a business imperative. Minimum $146,955.00 - Maximum $219,650.00, plus incentive opportunity: The range shown represents a typical pay range or starting pay for individuals who are hired in the role to perform in the United States. Other elements may be used to determine actual pay such as the candidate's job experience, specific skills, and comparison to internal incumbents currently in role. Typically, actual pay will be positioned within the established range, rather than at its minimum or maximum. This information is provided to applicants in accordance with states and local laws. **Application Deadline** : This will be posted for a minimum of 5 business days. **Company benefits:** Comprehensive medical, dental, vision, prescription drug coverage, company provided basic life, accidental death & dismemberment, short-term and long-term disability insurance, tuition reimbursement, student loan assistance, a generous 401(k) match, flexible time off, paid holidays, and paid leave programs as well as other company provided benefits. Come discover more about Otsuka and our benefit offerings; ********************************************* . **Disclaimer:** This job description is intended to describe the general nature and level of the work being performed by the people assigned to this position. It is not intended to include every job duty and responsibility specific to the position. Otsuka reserves the right to amend and change responsibilities to meet business and organizational needs as necessary. Otsuka is an equal opportunity employer. All qualified applicants are encouraged to apply and will be given consideration for employment without regard to race, color, sex, gender identity or gender expression, sexual orientation, age, disability, religion, national origin, veteran status, marital status, or any other legally protected characteristic. If you are a qualified individual with a disability or a disabled veteran, you may request a reasonable accommodation, if you are unable or limited in your ability to apply to this job opening as a result of your disability. You can request reasonable accommodations by contacting Accommodation Request (EEAccommodations@otsuka-us.com) . **Statement Regarding Job Recruiting Fraud Scams** At Otsuka we take security and protection of your personal information very seriously. Please be aware individuals may approach you and falsely present themselves as our employees or representatives. They may use this false pretense to try to gain access to your personal information or acquire money from you by offering fictitious employment opportunities purportedly on our behalf. Please understand, Otsuka will **never** ask for financial information of any kind or for payment of money during the job application process. We do not require any financial, credit card or bank account information and/or any payment of any kind to be considered for employment. We will also not offer you money to buy equipment, software, or for any other purpose during the job application process. If you are being asked to pay or offered money for equipment fees or some other application processing fee, even if claimed you will be reimbursed, this is not Otsuka. These claims are fraudulent and you are strongly advised to exercise caution when you receive such an offer of employment. Otsuka will also never ask you to download a third-party application in order to communicate about a legitimate job opportunity. Scammers may also send offers or claims from a fake email address or from Yahoo, Gmail, Hotmail, etc, and not from an official Otsuka email address. Please take extra caution while examining such an email address, as the scammers may misspell an official Otsuka email address and use a slightly modified version duplicating letters. To ensure that you are communicating about a legitimate job opportunity at Otsuka, please only deal directly with Otsuka through its official Otsuka Career website ******************************************************* . Otsuka will not be held liable or responsible for any claims, losses, damages or expenses resulting from job recruiting scams. If you suspect a position is fraudulent, please contact Otsuka's call center at: ************. If you believe you are the victim of fraud resulting from a job recruiting scam, please contact the FBI through the Internet Crime Complaint Center at: ******************* , or your local authorities. Otsuka America Pharmaceutical Inc., Otsuka Pharmaceutical Development & Commercialization, Inc., and Otsuka Precision Health, Inc. ("Otsuka") does not accept unsolicited assistance from search firms for employment opportunities. All CVs/resumes submitted by search firms to any Otsuka employee directly or through Otsuka's application portal without a valid written search agreement in place for the position will be considered Otsuka's sole property. No fee will be paid if a candidate is hired by Otsuka as a result of an agency referral where no pre-existing agreement is in place. Where agency agreements are in place, introductions are position specific. Please, no phone calls or emails.

Plans and coordinates activities to ensure Company project goals are accomplished within defined scope, time, and cost constraints. Project Manager provides leadership and executes strategy for Engineering Projects efforts in support of plant's strategic and production plans. He/she leads short-term and long-term capital projects, along with day-to-day Plant Engineering and Financial activities and team/suppliers' management. **Function Related Activities/Key Responsibilities:** **Strategic Planning and Capital Project Leadership** + Lead the planning, execution, and delivery of strategic capital projects in alignment with the company's strategic plan, budget, timelines, and quality standards. + Participate in strategic master planning and the definition of new technology projects aligned with CPS Global strategy. + Actively contribute to the CapEx Projects Justification process and serve as a key collaborator of the Capital Review Committee (CRC). **Project Execution and Delivery** + Develop and manage project scopes, schedules, milestones, and deliverables from initiation to commissioning. + Coordinate and supervise internal teams and contractors, ensuring compliance with contractual, safety, environmental, and regulatory requirements. + Oversee contractor performance, ensuring adherence to environmental, safety, ergonomic, and efficiency standards. + Conduct bidding analysis and contractor selection for CapEx projects, managing execution and quality throughout. + Ensure change management processes are followed for project specification modifications. **Communication, Reporting and Stakeholder Management** + Maintain effective and consistent communication with internal customers, contractors, and regulatory agencies. + Prepare and present regular status updates, performance metrics, and financial projections to management and stakeholders. + Ensure comprehensive documentation of project progress, decisions, and contractual matters. **Financial and Resource Management** + Manage project budgets, track expenditures, and identify budget deviations, escalating where necessary for strategic decisions. + Administer the capitalization process for assets purchased through capital funds. + Support monthly, quarterly, and annual financial reporting, including carryover and RFA (Request for Authorization) processes related to funding adjustments. **Compliance, Quality, and Risk Management** + Ensure all projects comply with applicable design codes, company standards, internal controls, environmental regulations, and legal requirements. + Integrate environmental performance indicators (air emissions, water consumption, energy efficiency) into project design, contractor selection, and evaluations. + Develop and enforce quality assurance plans, direct testing activities, and ensure accurate maintenance of project drawings and technical documentation. + Identify and mitigate project risks, ensuring issues are escalated promptly with proposed solutions. **Technical and Engineering Support** + Provide engineering consulting to other units, supporting current and future capital project needs. + Design, test, and procure specialized process equipment unique to the concentrate manufacturing business. + Ensure drafting resources maintain accurate, updated technical drawings with proper version control. + Develop and implement business processes to ensure projects meet all functional and technical requirements. **People Leadership and Development** + Coordinate the recruitment and allocation of internal and external project resources. + Provide training to new associates and contractors on company procedures, safety, and environmental standards relevant to assigned projects. + Foster collaboration, accountability, and continuous improvement among project teams and stakeholders. + Participate in the Vertical Start Up of each Strategic project under his/her scope. **Education Requirements:** + Architecture, Civil, Industrial, Mechanical or Electrical. Chemical Engineer, of Foods, or similar graduation. + Fluent in English & Spanish **Related Work Experience:** Desirable Experience of minimum 7 years in the position or similar function as: + Operations Manager + Management of multi-disciplinary technical / engineering teams. + Proven experience in the installation and commissioning of filling lines within an industrial manufacturing environment. + Major Capital Projects (specification, design, installation, commissioning, cost control, purchasing, contract, planning, risk analysis & avoidance). **Communications Skills:** + Fluent English and Spanish verbal and written + Effective written and oral communication with cross-functional teams and management + Effectively communicates and influences non-technical senior managers. + Strong interpersonal and communication skills and the ability to work effectively with a diverse community **Functional Skills:** + Project Management + Business Excellence + Lean Manufacturing + Change Management + Structured Problem Solving **Skills:** Change Management; Project Management Improvement; Waterfall Model; Stakeholder Management Annual Incentive Reference Value Percentage:15 Annual Incentive reference value is a market-based competitive value for your role. It falls in the middle of the range for your role, indicating performance at target. We are an Equal Opportunity Employer and do not discriminate against any employee or applicant for employment because of race, color, sex, age, national origin, religion, sexual orientation, gender identity and/or expression, status as a veteran, and basis of disability or any other federal, state or local protected class.

LUMA - Built for Puerto Rico We rely on electricity every day. We need it to run our appliances, power the streetlights and produce the goods and services that drive our economy. At LUMA we are committed to provide Puerto Rico with electricity that we all can depend on. At LUMA, we put people first - our employees, our customers and the communities where we live and work. We encourage and inspire our people to embrace opportunities as they work to build an electricity system that will make Puerto Rico a better place. If you're looking for a career where you can make a tangible difference in the lives of your neighbors and your community, LUMA is the place for you. LUMA offers new jobs designed to respond to the current and future needs of the T&D system. Together we're transforming the island's electric transmission and distribution system, and energizing Puerto Rico. Please note that these new jobs with LUMA offer different terms and conditions of employment to those currently in place with PREPA. We will schedule interviews with all qualified PREPA candidates. All PREPA applicants will receive priority in hiring and a compensation package equal to or better than what they receive today. In order to receive notifications as additional positions and locations are posted, please create a profile on our career site. About the Position Reporting to the Senior Project Manager, the Project Manager, Transmission Projects, is responsible for the overall project planning, organizing, management, coordination and administration of capital project work for transmission level substation and line work in order to achieve project completion on budget, on time, as per agreed scope and with proper risk and quality management. This position supports LUMA through the planning and delivery of project work through all phases of new capital projects and is responsible for the effective planning and delivery of all phases of project. What will you get up to everyday? Responsible for monitoring, tracking of schedules, costs, risks and quality, supervising and reporting on project deliverables including external contractors. Responsible for managing interfaces with contractors during construction and ensure that all Project deliverables are completed. Ensure contract policies and practices are followed to ensure the company achieves the accepted intent of agreements, have methods to manage change/exceptions and properly protects the company from failure risks. Effectively communicate with appropriate internal and external groups including Municipal, State and Federal agencies and contractors. Provide daily direction and mentorship to Project Coordinators to ensure that PMO Processes, Procedures, Quality Assurance and inspection programs are being adhered to. Lead and monitor the construction of all assigned projects for scope, schedule and cost changes and report on changes that can impact the project and provide advice on course of action to maintain the schedule within authority levels or escalate to quickly address. Excellent, organizational, communication, interpersonal and leadership skills. Excellent knowledge in Project Controls, scheduling, tasks development, WBS, Costs, Estimating, Risks and Reporting (to Regulatory and Federal Aid Agencies). Supervisory skills relating to site management of multiple work groups and contractors. Proven skills in Project Execution and Contractor Management. Perform other duties as assigned. Perform major storm restoration work and associated drills as assigned. Follow all policies and procedures. What We are Hoping You Bring to LUMA LUMA's culture is rooted in the concept of People First, Safety Always. We want your knowledge and expertise to pair with LUMA's globally recognized experts in numerous fields such as customer service, field workforce development, high-voltage transmission engineering, distributed energy resources and mini/micro grid integration. Our employees receive substantial training and development, as well as opportunities for advancement and success. Within our People First, Safety Always culture, we're committed to offering continuous learning opportunities and career-long support for our employees. Education Bachelor of Science, Engineering, Business, or technical institute Project management Professional (PMP or PgMP) training and experience would be considered an asset. Experience Minimum of 5 years experience in a large electrical utility environment with knowledge in design, construction, and commissioning of electric utility systems, equipment and components. Experience working on Regulated Utilities and managing project interfaces with Regulatory Commission and Independent System Operators, International Aid Agency Interfaces on Large Utility Scale. Expert knowledge in Project Controls, scheduling, tasks development, WBS, Costs, Estimating, Risks and Reporting. Expert in identifying and managing risk on projects. Licenses/Certifications Valid Driver's License. More Details on what to expect with this position at LUMA space Travel Requirements 30% Physical Demands Stationary Position: Constantly Pushing/ Pulling/ Reaching: N/A Climb: N/A Kneel: Seldom Grab: Seldom Bend: Seldom Lift/ Carry over: 31-50 LBS Vision: 20/20 Corrected Vision Hearing: Receive detailed information if spoken to. Working Conditions Wet or humid: Seldom Working near or on moving mechanical parts: Seldom Working near or on heavy machinery: Seldom Working in high places: Seldom Exposed to fumes or airborne particles: Seldom Exposed to toxic or caustic chemicals: Seldom Frequency of working in outdoor weather conditions: Seldom Work with electricity: Seldom Work with explosives: N/A Work on or near a source of radiation: N/A Loud Noise conditions (abover 87 db): Seldom Other environmental factors including weather conditions: N/A Other: We are looking forward to seeing your application! You made it to the end of the job posting! Thank you for expressing interest in LUMA and taking the time to read all the details of this position. We encourage you to apply and give us the opportunity to get to know you better through the recruitment process. Together, we're energizing the people of Puerto Rico. Note: this job description is not designed to cover or contain a comprehensive listing of activities, duties or responsibilities that are required of the employee. Duties, responsibilities, working conditions, physical demands, and activities may change or new ones may be assigned at any time with or without notice. LUMA 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. This policy applies to all terms and conditions of employment, including recruiting, hiring, placement, promotion, termination, layoff, recall, transfer, leaves of absence, compensation and training.

Job DescriptionSalary: Want to be part of a transformative team? This job is for you! The CSV Account & Project Manager is responsible for managing client accounts, developing new business opportunities, and overseeing project execution for Moriahs services. This role combines technical project leadership with client service excellence, ensuring projects are delivered on time, on budget, and in compliance with all applicable standards, particularly in regulated industries such as pharmaceuticals and medical devices. Responsibilities Serve as primary point of contact for assigned clients, maintaining strong, long-term relationships. Identify areas of service (sales) opportunity & develop proposal. Supervise, coach and lead the department team for overall projects and department objectives. Coordinate with Project Lead Coordinators to manage timelines, deliverables, and resources. Partner with upper management to develop strategies for business development growth. Identify areas of opportunity to expand services and support proposal development. Act as technical consultant for automation and CSV solutions, providing strategic recommendations to clients. Lead and supervise cross-functional project teams in planning and execution. Promote team engagement, accountability, and high performance throughout project execution. Conduct performance evaluations, one-on-one meetings, and approve PTO. Ensure that all projects meet compliance standards (e.g., FDA, GMP) and client expectations. Maintain strong internal communication with operations and leadership teams. Qualifications Bachelors Degree Engineering, science or related field. Ability to plan, manage and execute complex project activities to a successful conclusion with little or no oversight. 5+ years of experience in engineering consulting, project management, or client facing technical roles. Proven experience in account management, sales, or consultative sales within technical or regulated industries. Experience with network and system administration of Microsoft based systems, Visual Studio, ASP.Net and SQL is preferred. Demonstrated successful communication and negotiation skills in order to manage conflicting and/or multiple demands, including ability to present to various level within an organization. Demonstrated ability to apply analytical skills to identify problems; recognizes symptoms, causes, and alternate solutions and makes timely sound decisions even under risk and uncertainty. Strong understanding of automation systems, PLCs, CSV, and related validation frameworks. Proven experience in CSV execution projects. Proven track record in business development within the pharmaceutical or regulated industries. Skilled in managing multiple projects, teams, and priorities in parallel. Proficiency in project management and CRM software. Bilingual (Spanish and English) preferred. Physical/Manufacturing Requirements Office and plant environment. Able to climb/ ladders/steps Able to lift items 25 lbs Keyboarding, lifting, standing, bending, walking. Travel or Environment Requirements Adhere to safe work practices Some travel (including international) required (Approx. 5% of time) We are an equal opportunity employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability, protected veteran status, or any other characteristic protected by applicable law.

Job Description Validation & Engineering Group, Inc. (V&EG) is a leading services supplier who provides solutions for the Pharmaceutical, Biotechnology, Chemical, Food, and Medical Devices industries in the following areas: Laboratory, Compliance, Computer, Engineering, Project Management, Validation, and other services. We are seeking a talented, dedicated individual committed to work under the highest ethics standards for the following position: CQV Project Manager The CQV Project Manager is responsible for leading the successful planning, execution, and delivery of Commissioning, Qualification, and Validation (CQV) activities for a biotechnology manufacturing project. This role requires coordination across functional teams-including QA, Engineering, Automation, Operations, and external vendors-to ensure the project achieves compliance with cGMP standards, adheres to schedule and budget constraints, and is aligned with the project's strategic objectives. The ideal candidate has a strong background in CQV delivery within biotech/pharmaceutical environments and experience managing multiple systems or project streams. Key Responsibilities: Project Planning & Execution Develop and maintain the integrated CQV project schedule, including commissioning and qualification activities for process, utility, and facility systems. Define project scope, milestones, deliverables, and resource requirements across upstream, downstream, and support systems. Coordinate and lead CQV planning meetings, system handoffs, and readiness reviews. Track progress against the CQV schedule; report status to stakeholders and leadership. Drive alignment with construction turnover and engineering deliverables (e.g., URS, design docs, P&IDs, FAT/SAT plans). Team Leadership & Resource Management Manage CQV team members and third-party contractors/consultants. Assign workstreams, ensure accountability, and monitor deliverable quality. Support onboarding and training of new team members and ensure safety and compliance awareness. Stakeholder Communication & Reporting Act as the primary point of contact for CQV-related activities, issues, and updates. Interface with QA, Facilities, Engineering, Manufacturing, and Automation to align schedules and priorities. Generate weekly/monthly progress reports, risk logs, and executive summaries. Compliance & Quality Oversight Ensure all CQV activities meet regulatory expectations (FDA, EMA), ASTM E2500, ISPE Baseline Guides, and internal procedures. Facilitate deviation management, change control impact assessments, and documentation reviews. Ensure that commissioning and qualification documentation supports future inspection readiness and PPQ requirements. Systems in Scope: Upstream and Downstream Biotech Process Equipment Clean Utilities (WFI, Clean Steam, Process Gases) Black Utilities (HVAC, Electrical, Water, Compressed Air) Automation Systems (DeltaV, SCADA, PLCs) Laboratory and QC Equipment Facility/Environmental Monitoring Systems Qualifications: Bachelor's degree in Engineering, Life Sciences, or related technical field. 8+ years of experience in the biopharma or biotech industry, with 4+ years in CQV project leadership roles. Strong knowledge of cGMP manufacturing operations and validation lifecycle requirements. Demonstrated experience managing complex CQV projects from design through operational readiness. Familiarity with scheduling software (e.g., MS Project, Primavera P6) and project management tools. Preferred Skills: PMP or equivalent project management certification. Experience with electronic validation systems (e.g., Valgenesis, Kneat). Experience supporting greenfield or large capital expansion projects. Strong interpersonal, organizational, and communication skills.

For Project Management services in the Manufacturing and Engineering area. WHAT MAKES YOU A FIT: The Technical Part: Bachelor's Degree in Engineering or related field and at least eight (8) years of previous exposure to Project Management activities within the regulated industry. Bilingual: (Spanish and English) Shift: Administrative & according to business needs Experience in: Capital project management Regulatory compliance (cGMP/cGLP/cGCP) Engineering coordination Contractor supervision Cost estimation & scheduling The Personality Part: Our Next Piece is someone who treats everyone they meet like family, especially our resources, clients and team members. In other words, being a customer service pro is one your (many) talents. Being the Piece means you're full of bright ideas and eager to innovate, always bringing top-quality results to the table. Are you ready to take on this new challenge? AS A PIECE OF FITS, YOU WILL: (The day-to-day on the job) Lead execution of assigned capital projects, ensuring timely documentation and alignment with site processes and systems. Ensure all activities comply with company policies, SOPs, values, and global regulatory standards. Manage multi-disciplinary projects from concept to completion, supporting site operations and business needs. Apply engineering principles to identify and resolve technical issues during project execution. Promote and enforce safety and cGMP compliance across all project phases and work environments. Oversee design development, including selection and coordination with A&E firms and internal stakeholders. Facilitate design reviews, meetings, and documentation of team decisions. Prepare and track project estimates, forecasts, schedules, and cost reports. Manage contractor activities, including bid reviews, inspections, and compliance with safety and quality standards. Provide technical support to site operations through investigations, assessments, and design input. WHO WE ARE: We are a Service Provider company different from the rest. We pride ourselves in how we treat the most important piece of our company's puzzle: you! We integrate Engineering, Construction, Maintenance, Utilities and Specialized Technical services across the Island (and in the US as well!). Our company is flexible, family-oriented and focused on our resources' well-being, while providing our Pharmaceutical, Medical Device and Manufacturing industry clients with top-notch quality talent. We're FITS! Are you the Next Piece?

City/Cities: Cidra Travel Required: 00% - 25% No Shift: Plans and coordinates activities to ensure Company project goals are accomplished within defined scope, time, and cost constraints. Project Manager provides leadership and executes strategy for Engineering Projects efforts in support of plant's strategic and production plans. He/she leads short-term and long-term capital projects, along with day-to-day Plant Engineering and Financial activities and team/suppliers' management. Function Related Activities/Key Responsibilities: Strategic Planning and Capital Project Leadership * Lead the planning, execution, and delivery of strategic capital projects in alignment with the company's strategic plan, budget, timelines, and quality standards. * Participate in strategic master planning and the definition of new technology projects aligned with CPS Global strategy. * Actively contribute to the CapEx Projects Justification process and serve as a key collaborator of the Capital Review Committee (CRC). Project Execution and Delivery * Develop and manage project scopes, schedules, milestones, and deliverables from initiation to commissioning. * Coordinate and supervise internal teams and contractors, ensuring compliance with contractual, safety, environmental, and regulatory requirements. * Oversee contractor performance, ensuring adherence to environmental, safety, ergonomic, and efficiency standards. * Conduct bidding analysis and contractor selection for CapEx projects, managing execution and quality throughout. * Ensure change management processes are followed for project specification modifications. Communication, Reporting and Stakeholder Management * Maintain effective and consistent communication with internal customers, contractors, and regulatory agencies. * Prepare and present regular status updates, performance metrics, and financial projections to management and stakeholders. * Ensure comprehensive documentation of project progress, decisions, and contractual matters. Financial and Resource Management * Manage project budgets, track expenditures, and identify budget deviations, escalating where necessary for strategic decisions. * Administer the capitalization process for assets purchased through capital funds. * Support monthly, quarterly, and annual financial reporting, including carryover and RFA (Request for Authorization) processes related to funding adjustments. Compliance, Quality, and Risk Management * Ensure all projects comply with applicable design codes, company standards, internal controls, environmental regulations, and legal requirements. * Integrate environmental performance indicators (air emissions, water consumption, energy efficiency) into project design, contractor selection, and evaluations. * Develop and enforce quality assurance plans, direct testing activities, and ensure accurate maintenance of project drawings and technical documentation. * Identify and mitigate project risks, ensuring issues are escalated promptly with proposed solutions. Technical and Engineering Support * Provide engineering consulting to other units, supporting current and future capital project needs. * Design, test, and procure specialized process equipment unique to the concentrate manufacturing business. * Ensure drafting resources maintain accurate, updated technical drawings with proper version control. * Develop and implement business processes to ensure projects meet all functional and technical requirements. People Leadership and Development * Coordinate the recruitment and allocation of internal and external project resources. * Provide training to new associates and contractors on company procedures, safety, and environmental standards relevant to assigned projects. * Foster collaboration, accountability, and continuous improvement among project teams and stakeholders. * Participate in the Vertical Start Up of each Strategic project under his/her scope. Education Requirements: * Architecture, Civil, Industrial, Mechanical or Electrical. Chemical Engineer, of Foods, or similar graduation. * Fluent in English & Spanish Related Work Experience: Desirable Experience of minimum 7 years in the position or similar function as: * Operations Manager * Management of multi-disciplinary technical / engineering teams. * Proven experience in the installation and commissioning of filling lines within an industrial manufacturing environment. * Major Capital Projects (specification, design, installation, commissioning, cost control, purchasing, contract, planning, risk analysis & avoidance). Communications Skills: * Fluent English and Spanish verbal and written * Effective written and oral communication with cross-functional teams and management * Effectively communicates and influences non-technical senior managers. * Strong interpersonal and communication skills and the ability to work effectively with a diverse community Functional Skills: * Project Management * Business Excellence * Lean Manufacturing * Change Management * Structured Problem Solving Skills: Change Management, Project Management Improvement, Stakeholder Management, Waterfall Model Our Purpose and Growth Culture: We are taking deliberate action to nurture an inclusive culture that is grounded in our company purpose, to refresh the world and make a difference. We act with a growth mindset, take an expansive approach to what's possible and believe in continuous learning to improve our business and ourselves. We focus on four key behaviors - curious, empowered, inclusive and agile - and value how we work as much as what we achieve. We believe that our culture is one of the reasons our company continues to thrive after 130+ years. Visit Our Purpose and Vision to learn more about these behaviors and how you can bring them to life in your next role at Coca-Cola.

For Project Management services. WHAT MAKES YOU A FIT: The Technical Part: Bachelor of Science in Engineering and at least five (5) years of experience in Project Management within the Pharmaceutical Industry. Shift: Administrative and according to business needs. Bilingual: English and Spanish (verbal/written). Experience in: Project Management life cycle: Scope of Work, Cost Estimate, procurement, bidding process, scheduling, project control, contractor supervision, and start-up. Understanding of pharmaceutical manufacturing processes, regulations, and industry best practices. The Personality Part: Our Next Piece is someone who treats everyone they meet like family, especially our resources, clients, and team members. In other words, being a customer service pro is one of your (many) talents. Being the Piece means you're full of bright ideas and eager to innovate, always bringing top-quality results to the table. Are you ready to Be The Piece? AS A PIECE OF FITS, YOU WILL: (The day-to-day on the job) Support Project Managers in the specific project assigned by the Project Manager to track scope, schedule, cost and resources against approved funds. Assist the sponsor of the project in the preparation of client funding documents. Participates in meetings and coordinates cost meetings with project staff. Provide project engineering and technical advice. Review project plan to be generated by the various system integrators. Review contractors project schedule, provide feedback and procure alignment with overall project schedule and each building operational windows. Lead weekly project planning and execution meetings. Identified key support resources needed for documentation approval and execution, followup for timely execution. Support cutover windows coordination with different buildings. Support field-testing activities. Support field walkdowns. Attend building operational windows planning meetings. WHO WE ARE: We are a Service Provider company different from the rest. We pride ourselves in how we treat the most important piece of our company's puzzle: you! We integrate Engineering, Construction, Maintenance, Utilities and Specialized Technical services across the Island (and in the US as well!). Our company is flexible, family-oriented and focused on our resources' well-being, while providing our Pharmaceutical, Medical Device and Manufacturing industry clients with top-notch quality talent. We're FITS! Are you the Next Piece?