Production Manager
Production manager job in Arecibo, PR
Eaton's ES AMER PCS division is currently seeking a Production Manager. What you'll do: Essential Functions: List the essential functions which must be performed in order to fulfill the purpose of your position as described above. 1. Monitors production activities to eliminate delays and ensure adherence to production and shipping schedules.
2.
Directs preparation of cost control reports, cost estimates, manpower and facilities requirement forecasts.
3.
Directs the plant manufacturing and production activities toward the accomplishment of corporate objectives.
4.
Directs the manufacture of all plant products at lowest cost consistently with established specifications as to quality and quantity.
5.
Plans, directs and supervises activities of supervisors of various sections in the performance of their assigned responsibilities.
7.
Coordinates and collaborates with other departments of the division in establishing and carrying out responsibilities.
8.
Oversees installation and maintenance of all processing equipment used in manufacturing.
9.
Develops and recommends plant manufacturing and operating profit.
10.
Implements plant policies and supervise the application of such policies to the plant's manufacturing operations.
11. Plans production schedules so that daily and monthly loads may be kept.
12.
Assists immediate supervisor, staff personnel or others with problems related to operation of section.
13.
Maintains good housekeeping practices and safety by reviewing the sections with the supervisor.
14.
Insures timely order placing and expediting.
15.
Monitors and follow up on inventory levels to fulfill production demands. Maintains appropriate inventory levels.
#Li-SL4
What you'll do:
16.
Coordinates and collaborates with other departments in order to obtain good information for the benefit of our customers.
17.
Maintains daily and monthly performance records.
18. Responsible for the deployment of Continuous Improvement tools at the Production Area
19. Lead and support Operational Outstanding Events and World Class Manufacturing
20. Champion Tier meetings at the Assembly Area.
21.
Responsibilities related to Health, Safety and Environment (EHS):
1. Attend and performs all EHS training assigned.
2. Promotes MESH processes and policies to his department employees.
3. Provides all resources needed to ensure that all MESH policies and procedures all performed by all personnel under his/her supervision.
IIoT Project responsibilities and accountabilities based on role scope:
* Discuss Key metrics on Tier 2, Use IIOT information to define fast response actions. Follow actions with the respectively team. Support Usage of IIOT system through the plant. Thru IIOT Dashboard, Visual Display, Tier 2 Board
* Discuss Key metrics daily with production floor manufacturing /support personnel (safety, quality issues, daily previous production, actions and usage of IIOT system) thru IIOT Dashboard, Visual Display, Tier 1 Board
* Maintain and enforce usage of TDM and PDES system in mfg. areas thru Shop Floor Connectivity
* PDES / UI support & maintenance thru Shop Floor Connectivity
* Workstation - ongoing support & maintenance thru Infrastructure
Qualifications:
Specialized Knowledge: Describe any specialized knowledge (e.g., technical, scientific, administrative) which your position requires.
EDUCATION: Engineering Degree
EXPERIENCE: Minimum five years' experience in management and ten years of experience in Manufacturing
1.
Manufacturing Management
2.
Manufacturing Excellence
3.
Cost Productivity
4.
Talent Development
We are committed to ensuring equal employment opportunities for job applicants and employees. Our recruitment processes use balanced selection criteria and avoid unlawful discrimination against applicants on the basis of their age, colour, disability, marital status, national origin, gender, gender identity, genetic information, race or racial origin, religion, sexual orientation or any other status protected or required by law.
Digital Manufacturing Director
Production manager job in Juncos, PR
At Medtronic you can begin a life-long career of exploration and innovation, while helping champion healthcare access and equity for all. You'll lead with purpose, breaking down barriers to innovation in a more connected, compassionate world. **A Day in the Life**
This position is an exciting opportunity to work with Medtronic's Diabetes business. Medtronic has announced its intention to separate the Diabetes division to promote future growth and innovation within the business and reallocate investments and resources across Medtronic, subject to applicable information and consultation requirements. This separation provides our team with a bold opportunity to unleash our potential, enabling us to operate with greater speed and agility. As a separate entity, we anticipate leveraging increased investments to drive meaningful innovation and enhance our impact on patient care.
The Digital Manufacturing Director will lead the transformation of our medical device manufacturing operations into an ISA-95-compliant, Industry 4.0-ready environment. This role combines strategic vision with hands-on technical leadership, ensuring automation, information systems, and data integrity work seamlessly within a regulated environment. The director will also oversee data analytics initiatives across automated and non-automated assets, leveraging predictive analytics and performance insights to drive operational excellence.
The ideal candidate brings deep expertise in manufacturing systems (MES, SCADA, ERP), ISA-95 architecture, latency mitigation strategies, and advanced analytics, with the ability to translate digital concepts into validated, compliant solutions that directly support production and patient safety.
Responsibilities may include the following and other duties may be assigned.
+ Plans, directs and implements all aspects of the company's design and development of new medical device products or software systems.
+ May develop, evaluate, implement and maintain technical quality assurance and control systems or reliability systems and standards pertaining to materials, techniques, or company products.
+ Oversees the investigation and evaluation of existing technologies.
+ Guides the conceptualization of new methodologies, materials, machines, processes or products.
+ Directs the development of new concepts from initial design to market release.
+ Manages feasibility studies of the design to determine if capable of functioning as intended.
+ Monitors documentation maintenance throughout all phases of research and development.
+ Organizes the coordination of activities with outside suppliers and consultants to ensure timely delivery.
+ Selects, develops and evaluates personnel to ensure the efficient operation of the function.
+ **Strategic Leadership**
+ Develop and execute the ISA-95-based Digital Manufacturing Roadmap, aligned with corporate manufacturing and quality strategy.
+ Define and lead Industry 4.0 initiatives.
+ Establish layered architecture for data flow and system interoperability across ERP, MES, SCADA, historians, and automation layers.
+ Partner with IT, Quality, and Operations to ensure data integrity, traceability, and system validation (21 CFR Part 11, GxP).
+ Drive global governance and standardization of digital manufacturing platforms and analytics frameworks.
+ **Operational & Hands-On Execution**
+ Oversee deployment, integration, and validation of MES, OPC-UA gateways, historians (OSIsoft PI), and analytics platforms.
+ Implement ISA-95 layered architecture and best practices:
+ Network segmentation
+ Event-driven communication (push vs. poll)
+ Edge processing near PLCs
+ Enable parametric data capture and SPC evidence through validated historian systems.
+ Lead stress testing and performance validation to improve latency
+ Develop and manage data analytics programs to:
+ Aggregate data from automated and non-automated assets
+ Apply predictive analytics for equipment performance, quality trends, and process optimization
+ Support OEE dashboards and advanced KPI reporting
+ **Leadership & Change Management**
+ Build and lead a cross-functional Digital Factory team combining automation, data, and IT system engineers.
+ Champion digital culture and ISA-95 compliance mindset across manufacturing and quality functions.
+ Manage vendor relationships for MES, historians, OPC-UA gateways, and analytics platforms.
+ Develop training programs to strengthen digital competencies and data-driven decision-making.
**Must Have: Minimum Requirements**
+ Requires Engineering bachelor's degree
+ Requires minimum of 10 years of relevant experience with 7+ years of managerial experience, or advanced degree with a minimum of 8 years relevant experience with 7+ years of managerial experience.
**Nice to Have:**
**Education & Experience**
+ Bachelor's degree in Engineering, Manufacturing Systems, Computer Science or related technical discipline
+ 10+ years of experience in medical device or life sciences manufacturing, with strong exposure to automation and information systems.
+ Proven track record leading ISA-95-compliant digital transformation and analytics initiatives in regulated environments.
+ Deep knowledge of cGMP, ISO 13485, FDA 21 CFR Part 11, and data integrity principles.
**Technical Skills**
+ Expertise in MES, SCADA, PLCs, OPC-UA gateways, historians (OSIsoft PI), and ERP integration.
+ Strong understanding of ISA-95 architecture, system validation (CSV), and latency mitigation strategies.
+ Experience with data analytics platforms (Power BI, Tableau, or similar), predictive modeling, and machine learning for manufacturing.
+ Familiarity with cybersecurity in OT environments, edge/cloud architectures, and IIoT readiness.
+ Knowledge of automation systems (robots, vision, feeders) and their role in validated processes.
**Leadership Attributes**
+ Hands-on leader with strong technical intuition and problem-solving skills.
+ Strategic thinker able to balance innovation, latency performance, and regulatory rigor.
+ Strong communicator who can bridge technical, quality, and business perspectives.
+ Collaborative and pragmatic, capable of leading through influence and credibility.
**Key Performance Indicators (KPIs)**
+ Execution of **ISA-95 Digital Factory Roadmap** and adoption of global digital standards.
+ Reduction in **communication faults and latency issues** across MES and PLC layers.
+ Compliance and audit readiness of digital systems (validated states maintained).
+ Integration maturity and uptime of digital systems and automation infrastructure.
+ Predictive analytics adoption and measurable improvements in OEE, quality, and downtime reduction.
**Physical Job Requirements**
The above statements are intended to describe the general nature and level of work being performed by employees assigned to this position, but they are not an exhaustive list of all the required responsibilities and skills of this position.
The physical demands described within the Responsibilities section of this job description 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. For Office Roles: While performing the duties of this job, the employee is regularly required to be independently mobile. The employee is also required to interact with a computer, and communicate with peers and co-workers. Contact your manager or local HR to understand the Work Conditions and Physical requirements that may be specific to each role.
**Benefits & Compensation**
**Medtronic offers a competitive Salary and flexible Benefits Package**
A commitment to our employees lives at the core of our values. We recognize their contributions. They share in the success they help to create. We offer a wide range of benefits, resources, and competitive compensation plans designed to support you at every career and life stage.
This position is eligible for a short-term incentive called the Medtronic Incentive Plan (MIP).
This position is eligible for an annual long-term incentive plan.
Medtronic benefits and compensation plans (**************************************************************************************************************
**About Medtronic**
We lead global healthcare technology and boldly attack the most challenging health problems facing humanity by searching out and finding solutions.
Our Mission - to alleviate pain, restore health, and extend life - unites a global team of 95,000+ passionate people.
We are engineers at heart- putting ambitious ideas to work to generate real solutions for real people. From the R&D lab, to the factory floor, to the conference room, every one of us experiments, creates, builds, improves and solves. We have the talent, diverse perspectives, and guts to engineer the extraordinary.
Learn more about our business, mission, and our commitment to diversity here (*************************
It is the policy of Medtronic to provide equal employment opportunity (EEO) to all persons regardless of age, color, national origin, citizenship status, physical or mental disability, race, religion, creed, gender, sex, sexual orientation, gender identity and/or expression, genetic information, marital status, status with regard to public assistance, veteran status, or any other characteristic protected by federal, state or local law. In addition, Medtronic will provide reasonable accommodations for qualified individuals with disabilities.
If you are applying to perform work for Medtronic, Inc. ("Medtronic") in any position which will involve performing at least two (2) hours of work on average each week within the unincorporated areas of Los Angeles County, you can find here (*************************************************************************************************************************************** a list of all material job duties of the specific job position which Medtronic reasonably believes that criminal history may have a direct, adverse and negative relationship potentially resulting in the withdrawal of a conditional offer of employment. Medtronic will consider for employment qualified job applicants with arrest or conviction records in accordance with the Los Angeles County Fair Chance Ordinance for Employers and the California Fair Chance Act.
We lead global healthcare technology and boldly attack the most challenging health problems facing humanity by searching out and finding solutions.
Our Mission - to alleviate pain, restore health, and extend life - unites a global team of 95,000+ passionate people.
We are engineers at heart- putting ambitious ideas to work to generate real solutions for real people. From the R&D lab, to the factory floor, to the conference room, every one of us experiments, creates, builds, improves and solves. We have the talent, diverse perspectives, and guts to engineer the extraordinary.
**We change lives** . Each team member, each day, helps to improve and redefine how the world treats the most pressing health conditions, from heart disease to diabetes. Our industry leadership comes from the passion and ingenuity of our people. That's who we are. Working alongside one another, we use science, medicine, and a profound understanding of the human body to build extraordinary technologies that can transform lives.
**We build extraordinary solutions as one team** . With one Medtronic Mindset defining how we work. Speed and decisiveness run through our DNA. Diverse perspectives inspire our bold answers to any challenge that comes our way. And we deliver results the right way, breakthrough after patient breakthrough.
**This life-changing career is yours to engineer** . By bringing your ambitious ideas, unique perspective and contributions, you will...
+ **Build** a better future, amplifying your impact on the causes that matter to you and the world
+ **Grow** a career reflective of your passion and abilities
+ **Connect** to a dynamic and inclusive culture that welcomes the challenge of life-long learning
These commitments set our team apart from the rest:
**Experiences that put people first** . Respect for people is the hallmark of our humanity. It fuels our team to positively impact even a single life. And it means we put our people first at Medtronic as well, creating a culture of belonging and always pushing to get you the career-building resources you need.
**Life-transforming technologies** . No matter your role, you contribute to technologies that transform lives. What we build empowers patients to live life on their terms.
**Better outcomes for our world** . Here, it's about more than the bottom line. Our Mission to improve human welfare drives us. We advance healthcare, society, and equity with every design, inside and outside our walls.
**Insight-driven care** . Fresh viewpoints. Cutting-edge AI, data, and automation. You're shaping the future of healthcare technology and defining the next generation of breakthroughs in care
It is the policy of Medtronic to provide equal employment opportunity (EEO) to all persons regardless of age, color, national origin, citizenship status, physical or mental disability, race, religion, creed, gender, sex, sexual orientation, gender identity and/or expression, genetic information, marital status, status with regard to public assistance, veteran status, or any other characteristic protected by federal, state or local law. In addition, Medtronic will provide reasonable accommodations for qualified individuals with disabilities.
For sales reps and other patient facing field employees, going into a healthcare setting is considered an essential function of the job and we expect our employees to comply with all credentialing requirements at the hospitals or clinics they support.
This employer participates in the federal E-Verify program to confirm the identity and employment authorization of all newly hired employees. For further information about the E-Verify program, please click here (*********************************** .
For updates on job applications, please go to the candidate login page and sign in to check your application status.
If you need assistance completing your application please email *******************
To request removal of your personal information from our systems please email *****************************
Production Manager
Production manager job in Vega Baja, PR
At ABB, we help industries outrun - leaner and cleaner. Here, progress is an expectation - for you, your team, and the world. As a global market leader, we'll give you what you need to make it happen. It won't always be easy, growing takes grit. But at ABB, you'll never run alone. Run what runs the world.
This Position reports to:
Manufacturing Unit Manager
In this role, you will have the opportunity to ensure efficient and cost-effective production results. Each day, you will be responsible to meet order demand, specifications, quality, and planning targets through the coordination and management of plant equipment, personnel, and production processes (quantity, quality, budgeted costs, and proper productivity level). You will also showcase your expertise by developing programs, projects, goals, and metrics to lead the organization to the highest level of operational performance while optimizing working capital throughout Operations.
The work model for the role is onsite in Vega Baja
#LI-Onsite
This role is contributing to the Vega Baja facility in Puerto Rico. Main stakeholder is the Electrification Installation Products Division.
You will be mainly accountable for:
Develops programs, projects, goals, and metrics to drive the organization to the highest level of operational performance while optimizing working capital throughout operations
Collaborates with Operational Excellence teams to integrate lean manufacturing principles into production processes
Develops and executes plans to reduce non-value-added costs, increase revenues, and delight customers by delivering products on time with high factory and supplier yields while decreasing product field failure rates
Ensures that 4Q Program (the standard ABB process improvement methodology) training and methods are implemented into the organization
Oversees the creation of manufacturing subcontracts and manages subcontractors jointly with other involved disciplines, including Supply Chain Management (e.g., subcontract employees are provided guidance on health and safety requirements and work practices, issued permits to work)
Ensures compliance with Group health, safety, and environmental directives and regulations, while monitoring and reporting progress and results; assesses risks and safety hazards and implements plans to ensure people and equipment safety
Ensures (with HR Business Partner support) that the area of responsibility is properly organized, staffed, skilled, and directed; guides, motivates, and develops direct and indirect subordinates within HR policies
Carries out additional functions and assumes additional responsibilities related to the position, as needed and/or assigned
Qualifications for the role
Bachelor's or Master's degree in Engineering or Business Administration
Proficiency with System AS/400
5+ years of experience in a multinational business environment
Strong judgment and initiative with the ability to resolve complex problems, be a change agent who selects the most efficient methods of work execution
Knowledge and application of Lean practices
Demonstrated active listening abilities
Excellent communication and leadership skills
Advanced analytical and mathematical skills
Solid understanding of computerized systems
Strong oral and written communication skills in English and Spanish
Proven negotiation skills, with the ability to bring diverse stakeholders together and reconcile differences
Why ABB?
What's in it for you?
We want you to bring your full self to work-your ideas, your energy, your ambition. You'll have the tools and freedom to grow your skills, shape your path, and take on challenges that matter. Here, your work creates impact you can see and feel, every day.
ABB is an Equal Employment Opportunity and Affirmative Action employer for protected Veterans and Individuals with Disabilities at ABB.
All qualified applicants will receive consideration for employment without regard to their- sex (gender identity, gender expression, sexual orientation), marital status, citizenship, age, race and ethnicity, inclusive of traits historically associated with race or ethnicity, including but not limited to hair texture and protective hairstyles, color, religious creed, national origin, pregnancy, physical or mental disability, genetic information, protected Veteran status, or any other characteristic protected by federal and state law.
For more information regarding your (EEO) rights as an applicant, please visit the following websites: ********************************************************************************************
As an Equal Employment Opportunity and Affirmative Action Employer for Protected Veterans and Individuals with Disabilities, applicants may request to review the plan of a particular ABB facility between the hours of 9:00 A.M. - 5:00 P.M. EST Monday through Friday by contacting an ABB HR Representative at **************.
Protected Veterans and Individuals with Disabilities may request a reasonable accommodation if you are unable or limited in your ability to use or access ABB's career site as a result of your disability. You may request reasonable accommodations by calling an ABB HR Representative at ************** or by sending an email to ****************.
Resumes and applications will not be accepted in this manner.
We value people from different backgrounds. Could this be your story? Apply today or visit *********** to read more about us and learn about the impact of our solutions across the globe.
We value people from different backgrounds. Could this be your story? Apply today or visit *********** to read more about us and learn about the impact of our solutions across the globe.
Auto-ApplyEmbedded Camera Lead
Production manager job in San Juan, PR
We are the movers of the world and the makers of the future. We get up every day, roll up our sleeves and build a better world -- together. At Ford, we're all a part of something bigger than ourselves. Are you ready to change the way the world moves?
Ford's Electric Vehicles, Digital and Design (EVDD) team is charged with delivering the company's vision of a fully electric transportation future. EVDD is customer-obsessed, entrepreneurial, and data-driven and is dedicated to delivering industry-leading customer experience for electric vehicle buyers and owners. You'll join an agile team of doers pioneering our EV future by working collaboratively, staying focused on only what matters, and delivering excellence day in and day out. Join us to make positive change by helping build a better world where every person is free to move and pursue their dreams.
What you'll do...
+ Evaluate and provide feedback on embedded cameraelectronics stack
+ Integration of HDR capable image sensor
+ Bring up camera feed stack on ST micro controller
+ Bring up camera streaming over RTSP in zephyr or other RTOS
+ Calibrate ISP to ensure clear images in all lighting conditions
+ Create and implement an end of line camera calibration plan
+ Work with vendors and contract manufacturers to resolve issues
You'll have...
+ Embedded RTOS MCU Camera Experience
+ STM or NXP MCUs Experience Prefer
+ Camera sensors, drivers, algorithm development, Lens Distortion & Correction, Latency optimization, Performance & Stability
+ Electronic Image Stabilization
+ Computer Vision - Depth estimation, Visual Feature Extraction, ROS
+ Latency and performance optimization for Visual Perception
+ Secure Video, DRM, secure boot, Multimedia
Even better, you may have...
+ Prior Experience at places such as Wyze, Ring, Logitech
You may not check every box, or your experience may look a little different from what we've outlined, but if you think you can bring value to Ford Motor Company, we encourage you to apply!
As an established global company, we offer the benefit of choice. You can choose what your Ford future will look like: will your story span the globe, or keep you close to home? Will your career be a deep dive into what you love, or a series of new teams and new skills? Will you be a leader, a changemaker, a technical expert, a culture builder...or all of the above? No matter what you choose, we offer a work life that works for you, including:
- Immediate medical, dental, vision and prescription drug coverage
- Flexible family care days, paid parental leave, new parent ramp-up programs, subsidized back-up child care and more
- Family building benefits including adoption and surrogacy expense reimbursement, fertility treatments, and more
- Vehicle discount program for employees and family members and management leases
- Tuition assistance
- Established and active employee resource groups
- Paid time off for individual and team community service
- A generous schedule of paid holidays, including the week between Christmas and New Year's Day
- Paid time off and the option to purchase additional vacation time.
This position is a leadership level 6.
For more information on salary and benefits, click here:
*****************************
Visa sponsorship is available for this position.
Candidates for positions with Ford Motor Company must be legally authorized to work in the United States. Verification of employment eligibility will be required at the time of hire.
We are an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, religion, color, age, sex, national origin, sexual orientation, gender identity, disability status or protected veteran status. In the United States, if you need a reasonable accommodation for the online application process due to a disability, please call **************.
This position is hybrid. Candidates who are in commuting distance to a Ford hub location may be required to be onsite four or more days per week. #LI-Hybrid #LI-MZ1
**Requisition ID** : 53137
Actuarial Lead
Production manager job in San Juan, PR
GENERAL DESCRIPTION
Responsible for analyzing pricing, financial reporting and reserves, and product development for all companies' products. Accountable for assessing the financial risks associated with products, and related services. Provide guidance and analytical support to optimize pricing, manage risk, and ensure the financial stability and competitiveness of the organization.
ESSENTIAL FUNCTIONS
Researches and analyzes various types of data to produce reserve estimates and/or actuarial support for filings with state insurance departments; and/or to implement new rates and rating plans, using existing procedures, and recommending changes where appropriate.
Analyzes data for developing and proposing solutions for actuarial or product line management.
Oversees the determination of the reserve for claims necessary in the estimation of incurred claims included in the financial statements. Assess and recommend the actuarial liabilities/receivables to be reported in the financial statements.
Develop the budget by-product of both lines of business and create all necessary supporting documentation for internal and external purposes including but not limited to the budget package.
Responsible for the communication between the certifying actuary and the company, preparing data, and supporting assumption development with reviewers for rate and product approvals.
Participate in the development, which includes assessing the actuarial assumptions to be used in the pricing model, providing recommendations for product design, and completing the required documentation. Work with multidisciplinary areas to serve as liaison with external actuarial consultants.
Prepare experience studies and monitor each segment's profitability.
Participate in the development and revision of statistical and actuarial models that reflect the tendencies of costs and memberships by business segment.
Provides support and reviews the development of rates for capitated and FFS agreements.
Responsible for the design of reports and spreadsheets that describe and present actuarial and statistical information according to its type of financing.
Assess the actuarial impact of potential regulation changes that affect premium or medical costs and prepare a communication report describing the impact and the analysis developed.
Identify and report significant issues and underlying problems, accompanied by proposed solutions, promptly to leadership. Also, resolving issues before health plan performance results are impacted.
Prepare and deliver presentation materials for management level, internal or external users.
Participates and collaborates with internal and external audits, in the department processes automation, corporate and departmental projects, and other similar tasks.
Participates in the implementation of tactical plans, and follows up on assigned tasks, projects, or objectives to ensure that expectations are met.
Must comply fully and consistently with all company policies and procedures, with local and federal laws as well as with the regulations applicable to our Industry, to maintain appropriate business and employment practices.
May carry out other duties and responsibilities as assigned, according to the requirements of education and experience contained in this document.
MINIMUM QUALIFICATIONS
Education & Experience: Bachelor's degree (Master's degree, preferable) in Actuarial Sciences, Mathematics, Statistics, Finance, or Economy. At least five (5) years of previous experience in a managed-care environment preferably in the Healthcare industry.
Certifications / Licenses: completed at least four (4) SOA examinations.
Other: Knowledge of SQL, SAS, Oracle, and MS Office (Word, Excel). Possess an approved actuarial examination. Must be part of the Actuarial Association.
Languages:
Spanish - Advanced (writing, comprehension, reading, or conversational)
English - Advanced (writing, comprehension, reading, or conversational)
Job Type: Full-time
Salary: $92,000.00 - $98,000.00 per year
Benefits:
401(k)
Dental insurance
Health insurance
Life insurance
Paid time off
Vision insurance
Auto-ApplyHealth Information Operations Supervisor
Production manager job in San Juan, PR
Datavant is a data platform company and the world's leader in health data exchange. Our vision is that every healthcare decision is powered by the right data, at the right time, in the right format. Our platform is powered by the largest, most diverse health data network in the U.S., enabling data to be secure, accessible and usable to inform better health decisions. Datavant is trusted by the world's leading life sciences companies, government agencies, and those who deliver and pay for care.
By joining Datavant today, you're stepping onto a high-performing, values-driven team. Together, we're rising to the challenge of tackling some of healthcare's most complex problems with technology-forward solutions. Datavanters bring a diversity of professional, educational and life experiences to realize our bold vision for healthcare.
**You will:**
+ Have a passion to lead, train and motivate a growing and excited Team.
+ Communicate and collaborate with leadership on issues, opportunities, or challenges.
+ Lead Audit Team which receives requests from Payors
+ Review data and provide client and leadership solutions
+ Comfortable bringing new ideas, process improvement suggestions, and feedback to internal stakeholders.
+ Manage the Request coming in from the Risk Management Team of the client
+ Be the leader of client locations and plan for fluctuating needs.
+ Oversee the escalation calls from our centralized call centers
+ Participates in project teams and committees to advance operational Strategies and initiatives
+ Coordinates with location/client management on complex issues while building a strong relationship
**What you will bring to the table:**
+ A true leadership philosophy in which the goal of the leader is to serve
+ Ability to support clients and your Team working both on-site and remotely.
+ 1-2 years of Health Information related experience
+ Well-versed with HIPAA standards.
+ A knack for presenting to leadership, clients, and your Team via Video or in person.
+ Solution provider and forward thinking
+ Detail and quality oriented as it relates to accurate and compliant information for medical records.
+ Power BI, MS Office
**Bonus points if:**
+ EMR experience with EPIC, or Cerner.
+ Previous production/metric-based work experience
+ Team building and experience elevating individuals' careers.
Pay ranges for this job title may differ based on location, responsibilities, skills, experience, and other requirements of the role.
The estimated base pay range per hour for this role is:
$21.25-$27.13 USD
To ensure the safety of patients and staff, many of our clients require post-offer health screenings and proof and/or completion of various vaccinations such as the flu shot, Tdap, COVID-19, etc. Any requests to be exempted from these requirements will be reviewed by Datavant Human Resources and determined on a case-by-case basis. Depending on the state in which you will be working, exemptions may be available on the basis of disability, medical contraindications to the vaccine or any of its components, pregnancy or pregnancy-related medical conditions, and/or religion.
This job is not eligible for employment sponsorship.
Datavant is committed to a work environment free from job discrimination. We are proud to be an Equal Employment Opportunity employer and all qualified applicants will receive consideration for employment without regard to race, color, sex, sexual orientation, gender identity, religion, national origin, disability, veteran status, or other legally protected status. To learn more about our commitment, please review our EEO Commitment Statement here (************************************************** . Know Your Rights (*********************************************************************** , explore the resources available through the EEOC for more information regarding your legal rights and protections. In addition, Datavant does not and will not discharge or in any other manner discriminate against employees or applicants because they have inquired about, discussed, or disclosed their own pay.
At the end of this application, you will find a set of voluntary demographic questions. If you choose to respond, your answers will be anonymous and will help us identify areas for improvement in our recruitment process. (We can only see aggregate responses, not individual ones. In fact, we aren't even able to see whether you've responded.) Responding is entirely optional and will not affect your application or hiring process in any way.
Datavant is committed to working with and providing reasonable accommodations to individuals with physical and mental disabilities. If you need an accommodation while seeking employment, please request it here, (************************************************************** Id=**********48790029&layout Id=**********48795462) by selecting the 'Interview Accommodation Request' category. You will need your requisition ID when submitting your request, you can find instructions for locating it here (******************************************************************************************************* . Requests for reasonable accommodations will be reviewed on a case-by-case basis.
For more information about how we collect and use your data, please review our Privacy Policy (**************************************** .
WWTP Operations Lead Team
Production manager job in Catao, PR
Mentor Technical Group (MTG) provides a comprehensive portfolio of technical support and solutions for the FDA-regulated industry. As a world leader in life science engineering and technical solutions, MTG has the knowledge and experience to ensure compliance with pharmaceutical, biotechnology, and medical device safety and efficacy guidelines. With offices in Caguas, PR, Boston, MA & San Francisco, CA and we serve life sciences clients in six global markets: United States, Puerto Rico, Dominican Republic, Mexico, Germany, Canada, and South America
SUMMARY:
Responsible for defining, planning, developing, executing, and monitoring the proposed scope of work for the administration and operation of the laboratory, “limited maintenance,” and operations of the advanced wastewater treatment systems. Responsible for defining and negotiating strategies and programs related to wastewater treatment operations in accordance with the operational contract, ensuring compliance with client expectations and/or goals as well as regulatory requirements.
Creates, through leadership and results, a culture of safe and advanced operations that integrates all elements of operational excellence. Monitors advanced treatment processes and implements and executes continuous improvement initiatives for wastewater treatment operations. Influences clients to prioritize work plans and ensures total customer satisfaction in a cost-effective manner.
At times, and when required, may operate, control, monitor, and maintain the wastewater treatment system, which includes: effluent pumping systems, aerobic and anaerobic treatment systems, biogas treatment system (Thiopaq), laboratory area, solids separation (“Decanters”), biogas burning flares, softener systems, receiving and/or movement of production materials, and general (limited) maintenance, as required by the process.
REQUIREMENTS:
Education:
Bachelor's or master's degree in Environmental Engineering or Chemical Engineering
Experience:
Experience in the field of Environmental or Chemical Engineering, with emphasis on design, construction, operation, and/or maintenance of wastewater treatment systems; or equivalent management and supervisory experience in industrial or consulting roles within Quality, Environmental, and Occupational Safety Programs, with a record of excellence.
Additional Requirements:
Wastewater Treatment Plant Operator License - Category IV (for treatment plant) (preferred)
EIT and/or Engineer License from the Puerto Rico Department of State; CIAPR credentials (preferred)
Experience in Project Management (PMI) of advanced treatment systems
Knowledge in the operation and maintenance of systems through computerized controls (PLCs, HMIs, PCs, etc.)
Bilingual (English/Spanish)
Willing to work in shifts (7 days/24 hours), overtime, and during emergencies as required
Must observe and promote compliance with company safety rules, reporting any violation or deviation to the immediate supervisor
Work may be performed indoors and outdoors, occasionally at heights. Exposed to temperature changes, occasional heat, wet areas, high and low humidity, noise, and vibrations.
Mentor Technical Group es un empleador que ofrece igualdad de oportunidades y todos los solicitantes calificados recibirán consideración para el empleo sin importar raza, color, religión, sexo, orientación sexual, identidad de género, información genética, origen nacional, estado de veterano protegido, estado de discapacidad o cualquier otro grupo protegido por ley.
Mentor Technical Group is an equal opportunity employer, and all qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, genetic information, national origin, protected veteran status, disability status, or any other characteristic protected by law.
Auto-ApplyCommissioning & Qualification Lead (Facilities & Utilities) LL02-250822
Production manager job in Juncos, PR
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 for talented, dedicated individuals who are committed to work under the highest standards of ethics to and with expertise in the following areas:
Facility/Utility/HVAC CQV Lead
Responsibilities:
Develop and review with the Program Lead and the construction subcontractors the mechanical completion and start-up of facility/utility/HVAC equipment and systems.
Provide a list of potential gaps, opportunities for alignment of efforts and opportunities to leverage construction quality verifications into commissioning and qualification.
Determine whether the definition and timing of system handover as well as the timing of system turnover packages is sufficient to support the C&Q plan.
Develop and obtain approval of document templates.
Ensure that quality documents are produced.
Ensure that the deliverables are developed in the proper sequence, to the appropriate level of detail and with the expected quality.
Develop and track execution plans with Class Staff.
Communicate progress on an established team meeting schedule; promptly escalating any challenges/delays that may require additional support to resolve and remain on schedule.
Initiates change controls and document changes/creation as necessary.
Supports generation of validation and support documents (SOP's, Configuration Specification, etc.).
Executes validation protocols against systems as necessary.
Requirements:
Have substantial experience with integrated commissioning and qualification programs, and aseptic fill/finish facilities.
Ten (10) or more years preferred in a aseptic pharmaceutical manufacturing role with SME status in multiple Validation disciplines.
Bachelor's degree preferably in Science or Engineering discipline. Other disciplines and/or equivalent job experience will be considered.
Strong understanding of Regulatory Guidance Framework FDA/EU, Industry Best Practices and cGMPs.
Strong problem-solving and critical thinking skills with demonstrated ability to conduct technical programs and to achieve program goals; strong organization skills to handle and delegate multiple projects at differing levels of complexity.
Experience in C&Q of New classified and non-classified production areas and support areas
Experience in room qualification, disinfection efficacy and smoke studies.
Experience in C&Q of: WFI, clean steam, process gases, HVAC and associated classified spaces, Warehouse.
Experience in DQ, IQ, OQ, PQ.
Experience in enhanced commissioning/ leverage approach qualification efforts.
Experience working with Kneat.
Ability to work independently while maintaining communication with all team members.
Requires teamwork, leadership, and influencing skills with a strong focus on customer service.
Excellent communication skills, both written and verbal, are required.
Working Conditions
The incumbent will be required to work in an office environment potentially requiring ergonomic considerations.
The incumbent will be required to work in a conference room environment for moderate periods of time.
The incumbent will be required to work with computers for up to 8 hours per day, including typing and viewing computer screens during this time.
Occasional excursions to labs, production area or warehouse requiring some level of gowning.
Exposure to typical manufacturing, laboratory, mechanical and warehouse environments.
Commissioning & Qualification Lead (C&Q)
Production manager job in Juncos, PR
For C&Q services in Capital Projects area. WHAT MAKES YOU A FIT: The Technical Part:
Bachelor's Degree in Science or Engineering with five (5) years of experience in the validation life cycle, within the pharmaceutical industry.
Bilingual (English & Spanish).
Shift: Administrative, and according to business needs.
Experience in:
Sterile Product Filling Lines
Generation & Execution Protocols Commissioning, Qualification, and validation.
Develop validation engineering policies and procedures.
Remediation activities.
Project Management and lead
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)
Validation, Commissioning Qualification, Technical Writing, Protocol Drafting.
Review and Execution of deviation processes.
Develop validation engineering policies and procedures that affect multiple organizational units.
Supervise, coordinate, and review the work of a small staff of engineers and/or technicians on an ongoing basis and on a project basis.
Employ advanced validation engineering techniques and/or modifications of advanced techniques within the area of validation engineering expertise.
Apply knowledge of validation engineering principles and practices outside of the area of expertise to a broad variety of assignments in related fields.
Develop technical solutions to complex problems that require regular ingenuity and creativity.
Work with manufacturing, process development, utilities, facilities, labs, and/or quality assurance in developing requirements and recommendations for large and/or highly complex process, system/facility modifications.
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?
Auto-ApplyCivil Works Supervisor - Photovoltaic (PV) Plant 125 MW
Production manager job in Ponce, PR
In the framework of a Photovoltaic plant construction project (125MW), we are currently looking for a Civil Works Supervisor with emphasis on monitoring the work of civil subcontractors (progress, distribution of work, control of personnel and machinery).
Roles and Responsibilities:
Supervision of civil works on\-site: land preparation (earthworks), clearing, cable trenches, road construction, foundations for structures (for photovoltaic panels, came ra poles, transformation centers) and fencing (perimeter enclosures, access gates).
Organisation, planning and control of the work of civil works subcontractors: control of progress, distribution of work, control of personnel (delivery notes, listeria, etc.) and machinery, management of incidents and taking of measurements.
Support the quality department: filling in the required documents and following up on said documentation with the subcontractors.
Support the prevention department: complying with and enforcing compliance with all safety requirements on site.
Requirements
Bachelor's degree from an accredited university in Civil Engineering, Construction, or related discipline and 9 years of related experience, or in lieu of a degree, 15 years related experience with an emphasis on Civil (Mandatory: Valid License \/ Active membership with the CIAPR).
Experience working with, supervising, and administering subcontractors.
Knowledge of state, federal, and local contracting requirements.
Knowledge of local labor laws and issues.
Familiarity with photovoltaic and industry quality standards.
Demonstrated leadership in a team\-based environment.
Ability to work in a fast\-paced environment and under tight deadlines.
Must be physically able to conduct field inspections and participate in project walk\-downs which may require extensive walking in and around a construction site, walking on uneven surfaces.
Must be able to complete and pass a drug screen, physical, and background check which includes verification of employment and education.
Good knowledge in MS Word, Excel, PowerPoint, and other common applications used in the construction industry.
Fluency in English and Spanish is required.
Willingness to be located on remote site.
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Performance Supervisor
Production manager job in San Juan, PR
In the role of Performance Supervisor, you will be the leader of our associate staff. Critical to maintaining a positive and productive relationship with our associates, you are responsible for consistently exceeding established goals, demonstrating a commitment to customers, and a dedication to excellence and innovation.
Location: San Juan, PR
ESSENTIAL JOB FUNCTIONS:
+ Retains and reviews warehouse documents and business metrics.
+ Responsible for successfully organizing and executing the daily workflow plan to ensure hourly associates obtain the daily order volume and deliver the expected customer service.
+ Supervises and coordinates staff and operations in a logistics distribution environment, plans and assigns daily work, trains employees, and has authority for discipline and performance decisions
+ Oversee daily activities of employees working in various areas to ensure daily work volume and service level meets production standards.
+ Responsible for coaching employees on production performance, quality standards, and productivity goals in an hourly environment.
+ Will be responsible for coordinating training to ensure that all associates are properly trained, and all training is documented.
+ Ensure a strong safety awareness and safety culture.
+ Develop methods for improving operating efficiencies and implementing procedures/policies to drive production.
+ Lead and control activities of up to 35-50 associates in multiple job functions. Take precautions to protect warehouse contents against loss.
+ Communicate with SIMOS Operations Manager on matters of employee discipline, safety, vacations, attendance, and policy-related matters.
+ Responsible for ensuring SIMOS/customer workload specifications are met and accurate metrics of results are maintained.
EDUCATION/EXPERIENCE:
+ 2+ years of supervisory experience in a production-driven logistics and distribution environment.
+ Strong technical proficiency with computers and warehouse management systems.
+ Strong interpersonal skills with proven experience, training and supervising people.
+ Entrepreneurial spirit, someone looking to take ownership and work for results.
Salary Range: $49,176 - $61,470 annually, depending on experience and geographic location.
Please note that actual compensation offered may vary based on local pay requirements, and will meet or exceed state-specific minimum wage or salary thresholds.
Benefits and Well-Being:
We offer a competitive benefits package, including 6 paid holidays, 1 paid floating holiday and up to 20 days of Paid Time Off per year, Medical/Dental/Vision insurance, Company-matching 401(k) and Employee Stock Purchase Program, in addition to other programs and perks. More details about our benefits can be found here. (****************************************************************************************************************
TrueBlue, Inc. and its brands welcome and encourage applications from candidates with disabilities. Accommodations are available upon request for candidates taking part in the application or interview process. If you require disability-related accommodation during the application or interview process, please contact your Recruiter directly, Employee Relations at HR-Advice@trueblue.com, or **************. TrueBlue, Inc. and its brands will consult with all applicants who request disability-related accommodation during the application or interview process to ensure that the accommodation provided takes into account the applicant's individual accessibility needs.
We are an equal opportunity employer, and all qualified applicants will receive consideration for employment without regard to race, color, religion, sex, national origin, disability status, protected veteran status, sexual orientation, gender identity, or any other characteristic protected by law.
SIMOS, a TrueBlue company, is dedicated to driving productivity and success for leading companies by placing skilled, dedicated teams onsite in distribution, fulfillment, reverse logistics, and manufacturing roles. We uphold high standards in workforce management, providing clients with flexible staffing solutions that emphasize training, timely payments and adaptable schedules.
Our mission is to connect people with positions that match their skills and aspirations, fostering a supportive environment where individuals can thrive. With a focus on efficiency and client satisfaction, SIMOS offers performance-driven staffing solutions that help businesses reach their goals while providing meaningful work opportunities for our associates across North America.
WHS Supervisor
Production manager job in Carolina, PR
Job Title
Warehouse Supervisor
Job Description: The supervisor of the warehouse is trained to make the daily work plan and ensure daily operational.
efficiency. Supervise assigned tasks and ensured that the tasks are preformed correctly.
Specific Responsibilities:
Generate the daily work plan.
Supervise and make entries in Magaya of all the merchandise received in the facilities.
Supervise the dispatches, carry out the cargo releases of dispatched merchandise, collect signatures and
personal information of the customers for reference and then be able to archive them.
Supervisors need to verify that the cold rooms are in function and monitor the temperature and humidity.
control of those rooms.
Proportion inventory to the employees to verify and account for the different accounts stored in the
warehouse.
Supervise the loads and unloads of the trucks and containers.
Create and provide delivery documents to traffic so that they can work with the next day's deliveries.
Find solutions to any problem that may arise with a dispatch o receipt of merchandise.
Work with multiple assigned tasks.
Work under pressure.
Supervisor, Manufacturing / Operations- 3rd shift (Puerto Rico-Onsite)
Production manager job in Santa Isabel, PR
**Country:** United States of America ** Onsite **U.S. Citizen, U.S. Person, or Immigration Status Requirements:** U.S. citizenship is required, as only U.S. citizens are authorized to access information under this program/contract.
**Security Clearance:**
None/Not Required
Joining Collins Aerospace isn't just about finding a job; it's about embarking on a journey to redefine the future of aerospace technology.
Collins Aerospace, an RTX company, is a leader in technologically advanced and intelligent solutions for the global aerospace and defense industry. Collins Aerospace has the capabilities, comprehensive portfolio, and expertise to solve customers' toughest challenges and to meet the demands of a rapidly evolving global market.
We are seeking a dedicated Manufacturing Operations Supervisor to oversee a team of support and production-level employees. In this role, you will set day-to-day activities, assist in managing and monitoring production operations, maintenance, plant engineering, scheduling, and personnel. You will plan, design, and execute activities directly related to the physical creation of RTX products and the functional operation of RTX facilities, encompassing both professional and para-professional disciplines. Join our team to play a key role in maintaining and enhancing our manufacturing operations and facility functionality.
**What You Will Do**
+ Ensures all quality related items for one cell are complete and documented to meet established quality standards.
+ Assists in cost reduction and process improvement to ensure efficiency of operations and cost effectiveness.
+ Assists in scheduling for one cell so that production schedules are met.
+ Assists in sequencing of work, such as build and delivery, for a cell to optimize productivity.
+ Coordinates activities for materials and logistics problem resolution of a cell to ensure availability of materials and smooth operations.
+ Monitors cell performance and productivity of a cell to maximize productivity.
+ Assists in production innovation, including additive manufacturing, of a cell to enhance the cell's production capabilities.
+ Interfaces with customers to understand customer needs and issues and ensure that the customers receive satisfactory standards of services.
**Qualifications You Must Have**
+ Typically requires a University Degree and minimum 2 years of prior relevant experience
+ Demonstrated professional or educational experience communicating in English and Spanish (verbal and written).
+ U.S. citizenship is required, as only U.S. citizens are authorized to access information under this program/contract
**Qualifications We Prefer**
+ Bachelor's degree in engineering, preferred
+ Prior relevant experience with specialized knowledge of technical or operational practices
+ Strong data-driven decision-making and analytical thinking.
+ Communication and stakeholder management skills.
+ Ability to drive continuous improvement initiatives and influence change across the organization.
+ Experience managing high-demand or recovery situations (e.g., material shortages, supplier disruptions).
+ Experience supporting digital transformation, automation, or smart manufacturing initiatives is a plus
**What We Offer**
Some of our competitive benefits package includes:
+ Medical, dental, and vision insurance
+ Three weeks of vacation for newly hired employees
+ Generous 401(k) plan that includes employer matching funds
+ Participation in the Employee Scholar Program (ESP)
+ Life insurance and disability coverage
+ Employee Assistance Plan, including up to 8 free counseling sessions
+ And more!
**Learn More & Apply Now!**
The next chapter of our future as an aerospace company is here, and we are excited about what this means for our employees and customers! Get onboard the Collins Aerospace Operations team and play a part in managing our innovative products from inception to delivery. The Operations team continues to grow and aims to strengthen the connection of Manufacturing Operations, Supply Chain and Environment, Health & Safety (EH&S) across Collins Aerospace. In this dynamic environment, you will have the opportunity to network across our businesses and functions, all while improving the productivity, quality and efficiency of our operations worldwide.
*Please ensure the role type (defined below) is appropriate for your needs before applying to this role.
**Onsite:** Employees who are working in Onsite roles will work primarily onsite. This includes all production and maintenance employees, as they are essential to the development of our products.
At Collins, the paths we pave together lead to limitless possibility. And the bonds we form - with our customers and with each other -- propel us all higher, again and again.
Apply now and be part of the team that's redefining aerospace, every day.
_RTX is 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, age, disability or veteran status, or any other applicable state or federal protected class. RTX provides affirmative action in employment for qualified Individuals with a Disability and Protected Veterans in compliance with Section 503 of the Rehabilitation Act and the Vietnam Era Veterans' Readjustment Assistance Act._
**Privacy Policy and Terms:**
Click on this link (******************************************************** to read the Policy and Terms
Raytheon Technologies is An Equal Opportunity/Affirmative Action Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability or veteran status, age or any other federally protected class.
Digital Manufacturing Director
Production manager job in Juncos, PR
At Medtronic you can begin a life-long career of exploration and innovation, while helping champion healthcare access and equity for all. You'll lead with purpose, breaking down barriers to innovation in a more connected, compassionate world. A Day in the Life
This position is an exciting opportunity to work with Medtronic's Diabetes business. Medtronic has announced its intention to separate the Diabetes division to promote future growth and innovation within the business and reallocate investments and resources across Medtronic, subject to applicable information and consultation requirements. This separation provides our team with a bold opportunity to unleash our potential, enabling us to operate with greater speed and agility. As a separate entity, we anticipate leveraging increased investments to drive meaningful innovation and enhance our impact on patient care.
The Digital Manufacturing Director will lead the transformation of our medical device manufacturing operations into an ISA-95-compliant, Industry 4.0-ready environment. This role combines strategic vision with hands-on technical leadership, ensuring automation, information systems, and data integrity work seamlessly within a regulated environment. The director will also oversee data analytics initiatives across automated and non-automated assets, leveraging predictive analytics and performance insights to drive operational excellence.
The ideal candidate brings deep expertise in manufacturing systems (MES, SCADA, ERP), ISA-95 architecture, latency mitigation strategies, and advanced analytics, with the ability to translate digital concepts into validated, compliant solutions that directly support production and patient safety.
Responsibilities may include the following and other duties may be assigned.
* Plans, directs and implements all aspects of the company's design and development of new medical device products or software systems.
* May develop, evaluate, implement and maintain technical quality assurance and control systems or reliability systems and standards pertaining to materials, techniques, or company products.
* Oversees the investigation and evaluation of existing technologies.
* Guides the conceptualization of new methodologies, materials, machines, processes or products.
* Directs the development of new concepts from initial design to market release.
* Manages feasibility studies of the design to determine if capable of functioning as intended.
* Monitors documentation maintenance throughout all phases of research and development.
* Organizes the coordination of activities with outside suppliers and consultants to ensure timely delivery.
* Selects, develops and evaluates personnel to ensure the efficient operation of the function.
* Strategic Leadership
* Develop and execute the ISA-95-based Digital Manufacturing Roadmap, aligned with corporate manufacturing and quality strategy.
* Define and lead Industry 4.0 initiatives.
* Establish layered architecture for data flow and system interoperability across ERP, MES, SCADA, historians, and automation layers.
* Partner with IT, Quality, and Operations to ensure data integrity, traceability, and system validation (21 CFR Part 11, GxP).
* Drive global governance and standardization of digital manufacturing platforms and analytics frameworks.
* Operational & Hands-On Execution
* Oversee deployment, integration, and validation of MES, OPC-UA gateways, historians (OSIsoft PI), and analytics platforms.
* Implement ISA-95 layered architecture and best practices:
* Network segmentation
* Event-driven communication (push vs. poll)
* Edge processing near PLCs
* Enable parametric data capture and SPC evidence through validated historian systems.
* Lead stress testing and performance validation to improve latency
* Develop and manage data analytics programs to:
* Aggregate data from automated and non-automated assets
* Apply predictive analytics for equipment performance, quality trends, and process optimization
* Support OEE dashboards and advanced KPI reporting
* Leadership & Change Management
* Build and lead a cross-functional Digital Factory team combining automation, data, and IT system engineers.
* Champion digital culture and ISA-95 compliance mindset across manufacturing and quality functions.
* Manage vendor relationships for MES, historians, OPC-UA gateways, and analytics platforms.
* Develop training programs to strengthen digital competencies and data-driven decision-making.
Must Have: Minimum Requirements
* Requires Engineering bachelor's degree
* Requires minimum of 10 years of relevant experience with 7+ years of managerial experience, or advanced degree with a minimum of 8 years relevant experience with 7+ years of managerial experience.
Nice to Have:
Education & Experience
* Bachelor's degree in Engineering, Manufacturing Systems, Computer Science or related technical discipline
* 10+ years of experience in medical device or life sciences manufacturing, with strong exposure to automation and information systems.
* Proven track record leading ISA-95-compliant digital transformation and analytics initiatives in regulated environments.
* Deep knowledge of cGMP, ISO 13485, FDA 21 CFR Part 11, and data integrity principles.
Technical Skills
* Expertise in MES, SCADA, PLCs, OPC-UA gateways, historians (OSIsoft PI), and ERP integration.
* Strong understanding of ISA-95 architecture, system validation (CSV), and latency mitigation strategies.
* Experience with data analytics platforms (Power BI, Tableau, or similar), predictive modeling, and machine learning for manufacturing.
* Familiarity with cybersecurity in OT environments, edge/cloud architectures, and IIoT readiness.
* Knowledge of automation systems (robots, vision, feeders) and their role in validated processes.
Leadership Attributes
* Hands-on leader with strong technical intuition and problem-solving skills.
* Strategic thinker able to balance innovation, latency performance, and regulatory rigor.
* Strong communicator who can bridge technical, quality, and business perspectives.
* Collaborative and pragmatic, capable of leading through influence and credibility.
Key Performance Indicators (KPIs)
* Execution of ISA-95 Digital Factory Roadmap and adoption of global digital standards.
* Reduction in communication faults and latency issues across MES and PLC layers.
* Compliance and audit readiness of digital systems (validated states maintained).
* Integration maturity and uptime of digital systems and automation infrastructure.
* Predictive analytics adoption and measurable improvements in OEE, quality, and downtime reduction.
Physical Job Requirements
The above statements are intended to describe the general nature and level of work being performed by employees assigned to this position, but they are not an exhaustive list of all the required responsibilities and skills of this position.
The physical demands described within the Responsibilities section of this job description 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. For Office Roles: While performing the duties of this job, the employee is regularly required to be independently mobile. The employee is also required to interact with a computer, and communicate with peers and co-workers. Contact your manager or local HR to understand the Work Conditions and Physical requirements that may be specific to each role.
Benefits & Compensation
Medtronic offers a competitive Salary and flexible Benefits Package
A commitment to our employees lives at the core of our values. We recognize their contributions. They share in the success they help to create. We offer a wide range of benefits, resources, and competitive compensation plans designed to support you at every career and life stage.
This position is eligible for a short-term incentive called the Medtronic Incentive Plan (MIP).
This position is eligible for an annual long-term incentive plan.
Medtronic benefits and compensation plans
About Medtronic
We lead global healthcare technology and boldly attack the most challenging health problems facing humanity by searching out and finding solutions.
Our Mission - to alleviate pain, restore health, and extend life - unites a global team of 95,000+ passionate people.
We are engineers at heart- putting ambitious ideas to work to generate real solutions for real people. From the R&D lab, to the factory floor, to the conference room, every one of us experiments, creates, builds, improves and solves. We have the talent, diverse perspectives, and guts to engineer the extraordinary.
Learn more about our business, mission, and our commitment to diversity here
It is the policy of Medtronic to provide equal employment opportunity (EEO) to all persons regardless of age, color, national origin, citizenship status, physical or mental disability, race, religion, creed, gender, sex, sexual orientation, gender identity and/or expression, genetic information, marital status, status with regard to public assistance, veteran status, or any other characteristic protected by federal, state or local law. In addition, Medtronic will provide reasonable accommodations for qualified individuals with disabilities.
If you are applying to perform work for Medtronic, Inc. ("Medtronic") in any position which will involve performing at least two (2) hours of work on average each week within the unincorporated areas of Los Angeles County, you can find here a list of all material job duties of the specific job position which Medtronic reasonably believes that criminal history may have a direct, adverse and negative relationship potentially resulting in the withdrawal of a conditional offer of employment. Medtronic will consider for employment qualified job applicants with arrest or conviction records in accordance with the Los Angeles County Fair Chance Ordinance for Employers and the California Fair Chance Act.
Auto-ApplyManufacturing Supervisor (Second Shift)
Production manager job in Arecibo, PR
What you'll do: The Manufacturing Supervisor is responsible to directly supervise employees in the Production Department. Carries out supervisory responsibilities in accordance with the organization's policies and applicable laws. Responsibilities include interviewing, hiring, and training employees; planning, assigning, and directing work; appraising performance; rewarding and disciplining employees; addressing complaints and resolving problems.
* Complies with all the requirements in the operational procedures at the area of responsibility in order to meet the requirements of all applicable Quality System regulations.
* Use Problem Solving tools to resolve (Six Sigma, 8D) quality issues and establish systems to improve yield, reduce scrap and minimize rework.
* Develop employee Problem Solving Skills and establish metrics to monitor employee and area performance (area efficiency, utilization and equipment downtime) in terms of quality.
* Responsible for the execution of Continuous Improvement tools.
* Leads Tier 2 meetings and takes care of the updating and tracking process of Visual Boards.
* Responsible to meet daily production goals by following and prioritizing production schedules based on product introduction, equipment efficiency, materials supply and agenda.
* Plans and administers procedures and budgets. Makes budgetary recommendations on capital expenditures and direct/indirect labor.
Qualifications:
* Bachelor's degree in Business Administration, Industrial, Mechanical or Electrical Engineering
* 3 years leadership and supervisory experience in Manufacturing environment
* English and Spanish written and speaking.
* Computer literate: Intermediate knowledge and experience using: Microsoft Office Excel, Word and PowerPoint; and Inventory Management Systems.
* Availability to work the second shift (2:30 PM - 11:00 PM, Monday to Friday)
Skills:
* Thinks & Acts Strategically
* Builds Organizational Capabilities
* Gets results
#LI-MV1
Production Manager
Production manager job in Vega Baja, PR
At ABB, we help industries outrun - leaner and cleaner. Here, progress is an expectation - for you, your team, and the world. As a global market leader, we'll give you what you need to make it happen. It won't always be easy, growing takes grit. But at ABB, you'll never run alone. Run what runs the world.
This Position reports to:
Manufacturing Unit Manager
In this role, you will have the opportunity to ensure efficient and cost-effective production results. Each day, you will be responsible to meet order demand, specifications, quality, and planning targets through the coordination and management of plant equipment, personnel, and production processes (quantity, quality, budgeted costs, and proper productivity level). You will also showcase your expertise by developing programs, projects, goals, and metrics to lead the organization to the highest level of operational performance while optimizing working capital throughout Operations.
The work model for the role is onsite in Vega Baja
#LI-Onsite
This role is contributing to the Vega Baja facility in Puerto Rico. Main stakeholder is the Electrification Installation Products Division.
You will be mainly accountable for:
* Develops programs, projects, goals, and metrics to drive the organization to the highest level of operational performance while optimizing working capital throughout operations
* Collaborates with Operational Excellence teams to integrate lean manufacturing principles into production processes
* Develops and executes plans to reduce non-value-added costs, increase revenues, and delight customers by delivering products on time with high factory and supplier yields while decreasing product field failure rates
* Ensures that 4Q Program (the standard ABB process improvement methodology) training and methods are implemented into the organization
* Oversees the creation of manufacturing subcontracts and manages subcontractors jointly with other involved disciplines, including Supply Chain Management (e.g., subcontract employees are provided guidance on health and safety requirements and work practices, issued permits to work)
* Ensures compliance with Group health, safety, and environmental directives and regulations, while monitoring and reporting progress and results; assesses risks and safety hazards and implements plans to ensure people and equipment safety
* Ensures (with HR Business Partner support) that the area of responsibility is properly organized, staffed, skilled, and directed; guides, motivates, and develops direct and indirect subordinates within HR policies
* Carries out additional functions and assumes additional responsibilities related to the position, as needed and/or assigned
Qualifications for the role
* Bachelor's or Master's degree in Engineering or Business Administration
* Proficiency with System AS/400
* 5+ years of experience in a multinational business environment
* Strong judgment and initiative with the ability to resolve complex problems, be a change agent who selects the most efficient methods of work execution
* Knowledge and application of Lean practices
* Demonstrated active listening abilities
* Excellent communication and leadership skills
* Advanced analytical and mathematical skills
* Solid understanding of computerized systems
* Strong oral and written communication skills in English and Spanish
* Proven negotiation skills, with the ability to bring diverse stakeholders together and reconcile differences
Why ABB?
What's in it for you?
We want you to bring your full self to work-your ideas, your energy, your ambition. You'll have the tools and freedom to grow your skills, shape your path, and take on challenges that matter. Here, your work creates impact you can see and feel, every day.
ABB is an Equal Employment Opportunity and Affirmative Action employer for protected Veterans and Individuals with Disabilities at ABB.
All qualified applicants will receive consideration for employment without regard to their- sex (gender identity, gender expression, sexual orientation), marital status, citizenship, age, race and ethnicity, inclusive of traits historically associated with race or ethnicity, including but not limited to hair texture and protective hairstyles, color, religious creed, national origin, pregnancy, physical or mental disability, genetic information, protected Veteran status, or any other characteristic protected by federal and state law.
For more information regarding your (EEO) rights as an applicant, please visit the following websites: ********************************************************************************************
As an Equal Employment Opportunity and Affirmative Action Employer for Protected Veterans and Individuals with Disabilities, applicants may request to review the plan of a particular ABB facility between the hours of 9:00 A.M. - 5:00 P.M. EST Monday through Friday by contacting an ABB HR Representative at **************.
Protected Veterans and Individuals with Disabilities may request a reasonable accommodation if you are unable or limited in your ability to use or access ABB's career site as a result of your disability. You may request reasonable accommodations by calling an ABB HR Representative at ************** or by sending an email to ****************.
Resumes and applications will not be accepted in this manner.
We value people from different backgrounds. Could this be your story? Apply today or visit *********** to read more about us and learn about the impact of our solutions across the globe.
We value people from different backgrounds. Could this be your story? Apply today or visit *********** to read more about us and learn about the impact of our solutions across the globe.
LL03-251105 CIP/SIP CQV Lead for Biotech
Production manager job in Juncos, PR
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:
* CIP/SIP CQV Lead for Biotech
The CIP/SIP CQV Lead is responsible for the planning, coordination, and execution of all Commissioning, Qualification, and Validation (CQV) activities related to Cleaning-In-Place (CIP) and Sterilization-In-Place (SIP) systems within a biotech manufacturing environment.
This role ensures that cleaning and sterilization systems are installed, tested, and qualified in compliance with GMP, FDA, EMA, and ASTM E2500 standards, supporting readiness for process validation and commercial manufacturing.
Key Responsibilities
CQV Planning & Strategy
* Develop and maintain the CIP/SIP CQV Plan, integrating it with the overall project CQV Master Plan.
* Define the CQV scope, strategy, and approach for all CIP and SIP skids, loops, and interfaces.
* Coordinate with process design, automation, and operations teams to ensure system functionality meets User Requirements Specifications (URS).
* Lead risk assessments (RA/IOQ/Performance Qualification) and ensure alignment with site validation policies.
Commissioning & Qualification Execution
* Review and approve vendor FAT/SAT protocols for CIP/SIP equipment.
* Lead and oversee execution of IOQ and PQ protocols for CIP/SIP systems, including:
* Cleaning recipe verification
* Steam sterilization cycle qualification
* Temperature mapping, time/temperature distribution, and drainability studies
* Ensure qualification of utilities supporting CIP/SIP systems (Clean Steam, WFI, Process Air).
* Interface closely with Automation, Process, and QA Validation for recipe verification and data integrity.
Documentation & Compliance
* Develop and review URS, FAT/SAT, IOQ, and PQ documentation in compliance with ASTM E2500 and GAMP 5.
* Ensure traceability from design specifications through executed testing.
* Manage deviations, non-conformances, and change controls related to CIP/SIP systems.
* Prepare summary reports and ensure timely approval from Quality Assurance.
Cross-functional Collaboration
* Collaborate with Process Engineers, Automation, QA, and Manufacturing to ensure successful integration of CIP/SIP operations with process equipment.
* Support operations during process validation batches and cleaning validation campaigns.
* Provide training and technical guidance to CQV engineers and contractors executing test protocols.
Qualifications
Education
* Bachelors degree in Chemical, Mechanical, or Biochemical Engineering (or equivalent).
Experience
* Minimum 710 years of experience in CQV within biotech or pharmaceutical manufacturing environments.
* At least 3 years leading CQV activities for CIP/SIP systems or related sterile process equipment.
* Strong knowledge of cleaning validation, sterilization principles, and automation integration.
* Experience with DeltaV, SCADA, or PLC systems for CIP/SIP recipe management.
Technical Competencies
* Expertise in ASTM E2500, ISPE Baseline Guides, GAMP 5, and FDA/EMA guidelines.
* Proficiency in reviewing P&IDs, piping isometrics, and functional design specifications.
* Experience executing or overseeing FAT/SAT, IOQ, PQ activities.
* Familiarity with data integrity, 21 CFR Part 11, and electronic validation systems (e.g., Kneat, ValGenesis).
Soft Skills
* Excellent leadership and coordination abilities in multi-disciplinary project environments.
* Strong communication skills for interaction with QA, Engineering, and Operations.
* Analytical, detail-oriented, and proactive problem-solver.
* Capable of managing timelines, priorities, and multiple concurrent systems.
Preferred
* Experience with bioreactor, media/buffer prep, and downstream CIP/SIP integrations.
* Prior participation in greenfield or expansion projects for biotech facilities.
* Familiarity with LEED / sustainability concepts in clean utility systems.
Supervisor, Manufacturing / Operations- 3rd shift (Puerto Rico-Onsite)
Production manager job in Santa Isabel, PR
Country: United States of America Onsite U.S. Citizen, U.S. Person, or Immigration Status Requirements: U.S. citizenship is required, as only U.S. citizens are authorized to access information under this program/contract.
Security Clearance:
None/Not Required
Joining Collins Aerospace isn't just about finding a job; it's about embarking on a journey to redefine the future of aerospace technology.
Collins Aerospace, an RTX company, is a leader in technologically advanced and intelligent solutions for the global aerospace and defense industry. Collins Aerospace has the capabilities, comprehensive portfolio, and expertise to solve customers' toughest challenges and to meet the demands of a rapidly evolving global market.
We are seeking a dedicated Manufacturing Operations Supervisor to oversee a team of support and production-level employees. In this role, you will set day-to-day activities, assist in managing and monitoring production operations, maintenance, plant engineering, scheduling, and personnel. You will plan, design, and execute activities directly related to the physical creation of RTX products and the functional operation of RTX facilities, encompassing both professional and para-professional disciplines. Join our team to play a key role in maintaining and enhancing our manufacturing operations and facility functionality.
What You Will Do
* Ensures all quality related items for one cell are complete and documented to meet established quality standards.
* Assists in cost reduction and process improvement to ensure efficiency of operations and cost effectiveness.
* Assists in scheduling for one cell so that production schedules are met.
* Assists in sequencing of work, such as build and delivery, for a cell to optimize productivity.
* Coordinates activities for materials and logistics problem resolution of a cell to ensure availability of materials and smooth operations.
* Monitors cell performance and productivity of a cell to maximize productivity.
* Assists in production innovation, including additive manufacturing, of a cell to enhance the cell's production capabilities.
* Interfaces with customers to understand customer needs and issues and ensure that the customers receive satisfactory standards of services.
Qualifications You Must Have
* Typically requires a University Degree and minimum 2 years of prior relevant experience
* Demonstrated professional or educational experience communicating in English and Spanish (verbal and written).
* U.S. citizenship is required, as only U.S. citizens are authorized to access information under this program/contract
Qualifications We Prefer
* Bachelor's degree in engineering, preferred
* Prior relevant experience with specialized knowledge of technical or operational practices
* Strong data-driven decision-making and analytical thinking.
* Communication and stakeholder management skills.
* Ability to drive continuous improvement initiatives and influence change across the organization.
* Experience managing high-demand or recovery situations (e.g., material shortages, supplier disruptions).
* Experience supporting digital transformation, automation, or smart manufacturing initiatives is a plus
What We Offer
Some of our competitive benefits package includes:
* Medical, dental, and vision insurance
* Three weeks of vacation for newly hired employees
* Generous 401(k) plan that includes employer matching funds
* Participation in the Employee Scholar Program (ESP)
* Life insurance and disability coverage
* Employee Assistance Plan, including up to 8 free counseling sessions
* And more!
Learn More & Apply Now!
The next chapter of our future as an aerospace company is here, and we are excited about what this means for our employees and customers! Get onboard the Collins Aerospace Operations team and play a part in managing our innovative products from inception to delivery. The Operations team continues to grow and aims to strengthen the connection of Manufacturing Operations, Supply Chain and Environment, Health & Safety (EH&S) across Collins Aerospace. In this dynamic environment, you will have the opportunity to network across our businesses and functions, all while improving the productivity, quality and efficiency of our operations worldwide.
* Please ensure the role type (defined below) is appropriate for your needs before applying to this role.
Onsite: Employees who are working in Onsite roles will work primarily onsite. This includes all production and maintenance employees, as they are essential to the development of our products.
At Collins, the paths we pave together lead to limitless possibility. And the bonds we form - with our customers and with each other -- propel us all higher, again and again.
Apply now and be part of the team that's redefining aerospace, every day.
RTX is 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, age, disability or veteran status, or any other applicable state or federal protected class. RTX provides affirmative action in employment for qualified Individuals with a Disability and Protected Veterans in compliance with Section 503 of the Rehabilitation Act and the Vietnam Era Veterans' Readjustment Assistance Act.
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Auto-ApplyManufacturing Supervisor Feeders - 3rd Shift
Production manager job in Arecibo, PR
Eaton's ES AMER PCS division is currently seeking a Manufacturing Supervisor Feeders - 3rd Shift. What you'll do: Primary Function: The Manufacturing Supervisor is responsible to directly supervise employees in the Production Department. Carries out supervisory responsibilities in accordance with the organization's policies and applicable laws. Responsibilities include interviewing, hiring, and training employees; planning, assigning, and directing work; appraising performance; rewarding and disciplining employees; addressing complaints and resolving problems. Also, it is his/her responsibility to maintain a safe work environment free of any harassment, discrimination, and high on ethical/quality standards and following and modeling the Leadership Attributes as established by Eaton policies & procedures.
Essential Functions:
Safety
* Attend and perform all EHS training assigned.
* Promote MESH processes and policies to all employees under his/her supervision.
* Provide all resources needed to ensure that all MESH policies and procedures all performed by all personnel under his/her supervision.
* Actively participates in Job Safety Analysis and timely resolution of safety corrective actions.
Quality
* Complies with all the requirements in the operational procedures at the area of responsibility in order to meet the requirements of all applicable Quality System regulations.
* Use Problem Solving tools to resolve (Six Sigma, 8D) quality issues and establish systems to improve yield, reduce scrap and minimize rework.
* Develop employee Problem Solving Skills and establish metrics to monitor employee and area performance (area efficiency, utilization and equipment downtime) in terms of quality.
Delivery
* Applies Eaton Lean Six Sigma tools to improve materials flow through production shop floor.
* Interfaces with internal business partners to understand their needs related to technology, product reviews, performance objectives, device features/functions, cost, delivery schedules and quantities.
* Delivers process and manufacturing excellence.
#LI-DS2
Qualifications:
Inventory
* Work in close collaboration and partner with SCM, OPEX, Quality, HR, and Finance Teams to optimize overall operational efficiency and effectiveness.
* Assure the Material Management processes area are followed as required at the manufacturing to avoid manufacturing disruption, scrap or shortages.
Productivity
* Responsible for the execution of Continuous Improvement tools.
* Leads Tier 2 meetings and takes care of the updating and tracking process of Visual Boards.
* Responsible to meet daily production goals by following and prioritizing production schedules based on product introduction, equipment efficiency, materials supply and agenda.
* Plans and administers procedures and budgets. Makes budgetary recommendations on capital expenditures and direct/indirect labor.
* Performs operation analysis to maximize flow in the areas and to assure the best use of resources to achieve total product cycle time goals and the highest level of productivity.
* Provides the manufacturing direction to coordinators and employees to ensure completion of a daily manufacturing plan as specified by our planning groups.
* Responsible to monitor and control Overtime expenses and Absenteeism issues following available tools.
Skills:
Other: Builds Organizational Capability
* Responsible to implement strategic (manager level and above) and tactical manufacturing activities (supervisor level).
* Selects and develops personnel to ensure the efficient operation of the production function.
* Develops schedules and manpower requirements for assigned areas.
* Ensures proactive engagement and representation of Manufacturing within other Teams to support business continuity and continuous improvement.
* Support change management, process and design innovation, supply chain leverage, cost effectiveness and process robustness during development and manufacturing.
* Responsible for setting employee objectives linked to the Plants Key Operating Objectives and other key operational metrics.
* Responsible for on-time performance feedback, coaching and counseling to employees under his/her responsibility tied to established objectives, employee handbook, processes, policies and procedures.
* Pursues organizational development strategies for enhanced goal alignment, professional skills and organization flexibility.
* Develops and supports Business Team objectives utilizing Six-Sigma/Lean Techniques in support of continuous process improvement activities.
* Responsible of maintaining a functional cross training matrix between the employees.
* Assure of employee's timecard data entry and payment integrity through Time Attendance System.
* Performs other related duties as required
We are committed to ensuring equal employment opportunities for job applicants and employees. Our recruitment processes use balanced selection criteria and avoid unlawful discrimination against applicants on the basis of their age, colour, disability, marital status, national origin, gender, gender identity, genetic information, race or racial origin, religion, sexual orientation or any other status protected or required by law.
Commissioning & Qualification Lead (Facilities & Utilities) LL02-250822
Production manager job in Gurabo, PR
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 for talented, dedicated individuals who are committed to work under the highest standards of ethics to and with expertise in the following areas:
* Facility/Utility/HVAC CQV Lead
Responsibilities:
* Develop and review with the Program Lead and the construction subcontractors the mechanical completion and start-up of facility/utility/HVAC equipment and systems.
* Provide a list of potential gaps, opportunities for alignment of efforts and opportunities to leverage construction quality verifications into commissioning and qualification.
* Determine whether the definition and timing of system handover as well as the timing of system turnover packages is sufficient to support the C&Q plan.
* Develop and obtain approval of document templates.
* Ensure that quality documents are produced.
* Ensure that the deliverables are developed in the proper sequence, to the appropriate level of detail and with the expected quality.
* Develop and track execution plans with Class Staff.
* Communicate progress on an established team meeting schedule; promptly escalating any challenges/delays that may require additional support to resolve and remain on schedule.
* Initiates change controls and document changes/creation as necessary.
* Supports generation of validation and support documents (SOPs, Configuration Specification, etc.).
* Executes validation protocols against systems as necessary.
Requirements:
* Have substantial experience with integrated commissioning and qualification programs, and aseptic fill/finish facilities.
* Ten (10) or more years preferred in a aseptic pharmaceutical manufacturing role with SME status in multiple Validation disciplines.
* Bachelors degree preferably in Science or Engineering discipline. Other disciplines and/or equivalent job experience will be considered.
* Strong understanding of Regulatory Guidance Framework FDA/EU, Industry Best Practices and cGMPs.
* Strong problem-solving and critical thinking skills with demonstrated ability to conduct technical programs and to achieve program goals; strong organization skills to handle and delegate multiple projects at differing levels of complexity.
* Experience in C&Q of New classified and non-classified production areas and support areas
* Experience in room qualification, disinfection efficacy and smoke studies.
* Experience in C&Q of: WFI, clean steam, process gases, HVAC and associated classified spaces, Warehouse.
* Experience in DQ, IQ, OQ, PQ.
* Experience in enhanced commissioning/ leverage approach qualification efforts.
* Experience working with Kneat.
* Ability to work independently while maintaining communication with all team members.
* Requires teamwork, leadership, and influencing skills with a strong focus on customer service.
* Excellent communication skills, both written and verbal, are required.
* Working Conditions
* The incumbent will be required to work in an office environment potentially requiring ergonomic considerations.
* The incumbent will be required to work in a conference room environment for moderate periods of time.
* The incumbent will be required to work with computers for up to 8 hours per day, including typing and viewing computer screens during this time.
* Occasional excursions to labs, production area or warehouse requiring some level of gowning.
* Exposure to typical manufacturing, laboratory, mechanical and warehouse environments.