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Facilities/Engineering Manager jobs at Grifols - 133 jobs

  • Manager - Engineering & Maintenance

    Biocon 4.3company rating

    Cranbury, NJ jobs

    1. Equipment & Facility Maintenance Lead maintenance of OSD manufacturing equipment such as blenders, granulators, fluid bed dryers, sifters, mills, tablet presses, capsule fillers, coating pans, dust collectors, compressors, chillers, boilers, AHUs, and dehumidifiers. Implement robust Preventive Maintenance (PM) and predictive maintenance programs. Conduct breakdown investigations and implement corrective actions. Ensure critical facility systems (HVAC, electrical, plumbing, fire systems, BMS/EMS) are maintained and operate to required standards. 2. Regulatory Compliance & Documentation Ensure compliance with FDA, cGMP, 21 CFR Part 11, OSHA, and related regulatory requirements. Maintain records including PM logs, calibration reports, service documentation, change controls, deviations, and CAPAs. Support internal and external audits (FDA, DEA, ISO, and customer audits). 3. Utilities & HVAC Systems Management Manage key utilities such as compressed air, nitrogen, vacuum, HVAC, chilled water, steam, and RO/DI water systems. Ensure qualified and compliant environmental controls for classified OSD manufacturing areas. Maintain pressure cascades, temperature and humidity controls, and HEPA-filtered air systems. 4. Equipment Qualification & Validation Work with Validation and QA teams on IQ/OQ/PQ protocols. Manage requalification schedules and ensure equipment remains in a validated state. Provide engineering assessments for change controls. 5. Safety, Risk Management & Compliance Ensure adherence to OSHA, NFPA, and site safety requirements. Implement safety programs including LOTO, confined space, hot work, and electrical safety. Conduct incident investigations and lead corrective actions. 6. Spare Parts & Vendor Management Maintain optimum inventory of critical spare parts. Manage vendors, annual maintenance contracts (AMCs), and service agreements to control maintenance costs. Evaluate and onboard modern technologies and suppliers. Qualifications & Experience Education: Bachelor's degree in mechanical, Electrical, Chemical, or Industrial Engineering (or equivalent). Preferred: Master's degree or certifications such as CMRP or PMP. Experience: 8-15 years of engineering and maintenance experience in OSD pharmaceutical manufacturing. Strong knowledge of manufacturing and packaging equipment, utilities, HVAC, and cleanroom systems. Experience with FDA/DEA audits and equipment validation. Must have a valid work permit.
    $88k-119k yearly est. 2d ago
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  • Global Engineering Capital & Strategy Director

    Allergan 4.8company rating

    Greenlawn, NY jobs

    A global biopharmaceutical company is seeking a Capital Planning Leader in Greenlawn, New York. The successful candidate will provide leadership for capital strategy development, oversee capital planning processes, and lead project engineers. Candidates should hold a Bachelor's in Engineering and have 10-15 years of relevant experience. This role involves managing significant annual investments and optimizing the manufacturing network. A comprehensive benefits package is offered, along with participation in incentive programs. #J-18808-Ljbffr
    $156k-215k yearly est. 2d ago
  • Manager, Facilities & Utilities Maintenance

    Novo Nordisk 4.9company rating

    Boulder, CO jobs

    About the Department The Boulder Site is home to the specialized technical operations/CMC team for oligonucleotides and RNAi therapeutics. The CMC team works alongside Quality, Regulatory, Technical Operations and RNAi Early Development professionals at our Boulder, Colorado facility and works closely with our teams in Lexington, Massachusetts. Ranked the No. 1 Place to Live for the second consecutive year by U.S. News & World Report, Boulder is experiencing a renaissance in biotech investment and is one of the world's leading centers for oligonucleotide innovation and manufacturing. Together, we are driving change. Are you ready to make a difference? The Position Manage operation & maintenance of facility & utility systems. Manage Facilities staff. Collaborate with cross-functional teams. Manage service & maintenance for facility services, including but not limited to laboratory equipment, HVAC, WFI water, Waste systems, compressed gases, housekeeping, life safety. Relationships Reports to Senior Manager Facilities. Essential Functions * Coach & mentor direct reports * Ensure operation & maintenance is performed per HS&E & GMP requirements * Start-up operates & maintains Facility & Utility systems per stakeholder need and GMP documentation * Create and maintain all GMP documentation required for Facility and Utility * Collaborate with site operation to develop a site strategy * Implement standard communication methods to support stakeholders * Develop maintenance program * Prevent recurrence of Facility / Utility unscheduled events and non-conformance * Drive improvements to operation & maintenance * Overall management of all facility services, includes both hard and soft service * Collaborate with all site stakeholders at all levels * Manage & maintain the cleanliness & appearance of Boulder Facilities * Responsibilities include supporting 4949,4999 and 4780 Pearl East Circle * Provide adequate security in line with NN standards * Manage projects to support the site * Drive environmental, social & financial performance & support site strategy * Other accountabilities as assigned Physical Requirements May move equipment &/or supplies weighing up to 33 pounds within the facility using various body positions. May be required to be on your feet for up to a 8-hour shift. May require the ability to work in loud noise environments with hearing protections. Development of People Supervisory. Ensure that reporting personnel have individual development plans (IDP), with annual goals and measurements that are consistent with the priorities of the business, and that interim reviews are held so that their work is focused on those priorities, and they understand their level of accountability for results and the measurement process. Ensure that the IDP forms include completed learning and aspiration plans and are in place for all reporting personnel to enable the achievement of goals and capability to assume increased levels of responsibility. Manage the application and communication of all Novo Nordisk policies, procedures, and Novo Nordisk Way. Qualifications * Bachelor's Degree in technical field or equivalent combination of education & industry equivalent experience required * Minimum of three (3) years of leadership/supervisory experience in engineering, manufacturing or maintenance, preferably in a pharmaceutical/regulated industry preferred * Minimum of five (5) years of experience in facility & utility maintenance required * Expertise in utility systems, to include WFI, electrical & HVAC, life safety systems, wastewater systems required * Experience in starting a new facility and creating GMP documentation and processes preferred * Knowledgeable in the management of utilities systems in a GMP regulated environment required * Demonstrated leadership capabilities required * Demonstrated experience in managing budgets and vendor contracts >$100,000 preferred * Proven expertise in mentoring & staff development, change management, planning, organizing & managing execution required * Demonstrated communication, stakeholder management, problem solving & organization skills required * Skilled in revising work plans for complex issues addressed by cross functional teams preferred The base compensation range for this position is $96,670 to $178,840. Base compensation is determined based on a number of factors. This position is also eligible for a company bonus based on individual and company performance. Novo Nordisk offers long-term incentive compensation and/or company vehicles depending on the position's level or other company factors. Employees are also eligible to participate in Company employee benefit programs including medical, dental and vision coverage; life insurance; disability insurance; 401(k) savings plan; flexible spending accounts; employee assistance program; tuition reimbursement program; and voluntary benefits such as group legal, critical illness, identity theft protection, pet insurance and auto/home insurance. The Company also offers time off pursuant to its sick time policy, flex-able vacation policy, and parental leave policy. We commit to an inclusive recruitment process and equality of opportunity for all our job applicants. We're not your typical healthcare company. In a modern world of quick fixes, we focus on solutions to defeat serious chronic diseases and promote long-term health. Our unordinary mindset is at the heart of everything we do. We seek out new ideas and put people first as we push the boundaries of science, make healthcare more accessible, and treat, prevent, and even cure diseases that affect millions of lives. Because it takes an unordinary approach to drive real, lasting change in health. Novo Nordisk is an equal opportunity employer. Qualified applicants will receive consideration for employment without regard to race, ethnicity, color, religion, sex, gender identity, sexual orientation, national origin, disability, protected veteran status or any other characteristic protected by local, state or federal laws, rules or regulations. If you are interested in applying to Novo Nordisk and need special assistance or an accommodation to apply, please call us at **************. This contact is for accommodation requests only and cannot be used to inquire about the status of applications.
    $96.7k-178.8k yearly 25d ago
  • Director of Medical Records - Skilled Nursing Facility

    Cypress Cove Care Center 3.9company rating

    Crystal River, FL jobs

    Director of Medical Records Cypress Cove Care Center 700 SE Dr. Martin Luther King Jr. Avenue, Crystal River, FL 34429 Skilled Nursing Facility Full-Time | Day Shift Cypress Cove Care Center is seeking an experienced and detail-oriented Director of Medical Records to lead and oversee medical records operations in our stable, well-established skilled nursing facility. This is an excellent opportunity for a health information professional who values accuracy, compliance, and collaboration within a supportive leadership environment. About the Role The Director of Medical Records plays a vital role in ensuring the integrity, accuracy, and confidentiality of resident health records. This position works closely with nursing leadership, administration, and interdisciplinary teams to maintain compliance with regulatory standards and support high-quality resident care. Key Responsibilities Oversee and manage all medical records operations in accordance with state and federal regulations Ensure accuracy, completeness, and timely maintenance of resident medical records Monitor compliance with HIPAA, documentation standards, and survey readiness requirements Coordinate record audits, releases of information, and record retention processes Collaborate with nursing, therapy, and administrative teams to support documentation accuracy Educate staff on documentation requirements and best practices as needed Prepare medical records for audits, surveys, and quality reviews Maintain confidentiality and safeguard protected health information at all times Perform other duties as assigned Qualifications RHIT strongly preferred Minimum requirement: Certified Coding credential (CCA or CCS) Prior experience in medical records or health information management, preferably in a skilled nursing or healthcare setting Strong knowledge of medical terminology, documentation standards, and compliance requirements Close attention to detail with excellent organizational skills Ability to work independently and collaboratively with leadership and clinical teams Professional, dependable, and confidentiality-focused What We Offer Competitive compensation with an option for Daily Pay! Full-time, stable position in a skilled nursing facility Comprehensive benefits package including: Medical, dental, and vision insurance Paid Time Off (PTO) 401(k) with employer contributions Company-paid life insurance Supportive leadership and positive work culture Long-term career growth in a well-run facility If you are a detail-driven health information professional looking for a stable role with strong leadership support, we would love to connect with you. Apply today to join the Cypress Cove Care Center team. Job Duty Disclaimer This job description is not intended to be all-inclusive. Duties and responsibilities may be adjusted to meet resident, regulatory, and operational needs. Equal Opportunity Employer Cypress Cove Care Center is an Equal Opportunity Employer. All qualified applicants will receive consideration without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability, protected veteran status, or any other legally protected characteristic. All background screenings will be completed through: ******************************** #INDCC123 View all jobs at this company
    $55k-89k yearly est. 10d ago
  • Sr. Manager, Engineering, Maintenance & Facilities

    PCI Pharma Services 4.1company rating

    Madison, WI jobs

    Life changing therapies. Global impact. Bridge to thousands of biopharma companies and their patients. **We are PCI.** Our investment is in People who make an impact, drive progress and create a better tomorrow. Our strategy includes building teams across our global network to pioneer and shape the future of PCI. **Summary of Objective:** The senior manager is accountable for all aspects of Engineering, Instrumentation and Controls, Metrology, Utilities, Facilities, and Maintenance in supporting pharmaceutical product manufacturing across the PCI Madison, WI site. The senior manager provides leadership to ensure the highest level of quality and adherence to cGMPs across the site. This role is responsible for managing people, providing quality and technical direction, and actively participating in driving and developing strategies for continuous improvement within the department. Manages and oversees all areas of process engineering, automation, calibration, facilities, operation of utilities including HVAC, buildings and ground maintenance, and maintenance of utilities and facilities supporting aseptic operations. Additionally, responsible for management of site CAPEX projects and acts as site representative for PCI's Environmental, Social, and Governance program. **Essential Duties and Responsibilities:** To perform this job successfully, an individual must be able to perform each essential duty satisfactorily. The essential duties and responsibilities include the following but other duties may be assigned. + Ensures all aspects of engineering and facilities are adhering to cGMPS and PCI's established SOPs. Makes the necessary recommendations and changes to improve process efficiencies. + Ensures all projects are executed safely, on time, and within budget. + Identifies, prepares and leads site CAPEX projects. + Responsible for all aspects of Engineering, Instrumentation and Controls, Utilities, Facilities, and Maintenance programs. + Determine appropriate equipment, line, tooling, costs and capacities for new projects or changes to existing projects. + Instill a strong culture of Lean and Continuous Improvement through the use of the site maturity index. + Oversees the departmental budget and headcount + Provides coaching, mentoring and development to each direct report both in execution of their group responsibilities and in their own development. + Provides leadership to ensure engineering and facilities support manufacturing operations in a fashion that focuses on quality and adherence to the maintenance schedule in support of Operations + Directs general and specialized maintenance, CAPEX projects, facility renovation, construction, and repair of grounds, buildings, equipment, utility systems, at all manufacturing, warehousing and office facilities within the Madison, WI site. + Support a variety of regulatory and client audits. + Ensures team compliance with all corporate policies and procedures. + Provides guidance to people managers in the areas of compliance, safety, deviations, corrective and preventive actions, and investigations related to engineering, maintenance, and facilities areas. + Works closely with key functions such as Quality, Manufacturing, EH&S, Sales/Project Management, Global Engineering, and Global PMO to ensure internal and external clients' requirements are met. + Analyzes existing processes/unit operations and determine modifications necessary to improve safety, as needed and streamline processes. + Responsible for on time calibration and preventive maintenance schedules for 1300+ site assets including fill line equipment, clean utilities, and laboratory equipment. + Advanced knowledge and understanding of PLC programming and integration that support GMP automated system, vial transport equipment, clean utilities, sterilization equipment, and lyophilizers. + Supports Continuous improvement activities tied to budget goals and helps lead key ESG initiatives. + Directs assigned personnel, including performance evaluations, scheduling, orientation and training. Recommends employee hires, transfers, promotions, salary changes, discipline, terminations and similar actions, as appropriate. + Maintains the professional competence, knowledge and skills necessary for the satisfactory performance of all assigned responsibilities. + Provides leadership in analyzing and developing improvements in process efficiency, quality, safety and client relationships (internal and external). + Correctly implements industry best practices that will successfully withstand regulatory inspections by regulatory authorities. + Responsible for administration of Computerized Maintenance Management System (CMMS) and maintenance planning. + Part of the Site Leadership Team (SLT). + Performs other duties as assigned. **Qualifications:** The requirements listed below are representative of the knowledge, skill, and/or ability required for the stated position. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions. + Bachelor's degree in engineering discipline preferred. + Master's degree in engineering or business administration preferred. + Operational background in cGMP environment, preferably in aseptic manufacturing/engineering. + Demonstrated skill in managing a diverse population of professional, technical, and hourly personnel as well as external resources. + Experience in working with regulators during inspections/audits is highly desired. + 8+ years of experience in the field of technical engineering support to biopharma/pharm and/or medical device facilities. + 8-10 years of experience in management of professional and technical staff with accountability for objectives and subsequent evaluation. + 5-8 years of experience with engineering and maintenance support to biopharma/pharm and/or medical device facilities. + 5 years of experience managing subordinate people leaders with accountability for objectives and subsequent evaluation. + Experience with company financial systems and an understanding of accounting practices and financials a plus. + Experience with direct exposure to Customers in a CDMO business is a plus. + Demonstrate commitment to continuous improvement at all levels within the organization. + Excellent organizational skills + Ability to prioritize multiple ongoing projects and activities to meet customer and company timelines + Excellent verbal and written communication skills + Ability to effectively manage multiple projects, teams and technical staff at all levels + Ability to assess and develop organizational talent which includes engaging employees and driving technical and personal development. Setting future leadership for success. + Performance measurement and KPI Tracking and Reporting + Proficiency with MS Office suite is preferable. + Possess advanced leadership competencies which support the rigidity of GMP operations against the competing demands of a CDMO environment. + Leads by example to motivate and engage through clear communication, of vision and goals. + Demonstrates resilience and takes a proactive approach to change management to enable leaders to drive the change successfully. + Effective verbal and written communication with both internal and external contacts is critical to success + Oversees a wide array of subordinate managers, supervisors, and technicians across multiple shifts. + Set a clear vision and direction for the reporting functions, encouraging communication and a team-based approach. + **Join us and be part of building the bridge between life changing therapies and patients. Let's talk future** . Equal Employment Opportunity (EEO) Statement: PCI Pharma Services is an Equal Opportunity/Affirmative Action Employer. We do not unlawfully discriminate on the basis of race, color, religion, age, sex, creed, national origin, ancestry, citizenship status, marital or domestic or civil union status, familial status, affectional or sexual orientation, gender identity or expression, genetics, disability, military eligibility or veteran status, or any other protected status. \#LI-AL1 Join us and be part of building the bridge between life changing therapies and patients. Let's talk future (***************** **Equal Employment Opportunity (EEO) Statement:** _PCI Pharma Services is an Equal Opportunity/Affirmative Action Employer. We do not unlawfully discriminate on the basis of race, color, religion, age, sex, creed, national origin, ancestry, citizenship status, marital or domestic or civil union status, familial status, affectional or sexual orientation, gender identity or expression, genetics, disability, military eligibility or veteran status, or any other protected status._ _At PCI, Equity and Inclusion are at the core of our company's purpose: Together, delivering life-changing therapies. We are committed to cultivating an inclusive workplace by holding ourselves accountable to the highest standards of understanding, fairness, respect, and equal opportunity - at every level. We envision a PCI community where everyone can belong and grow, and we strive to bring this vision to reality by continuously and intentionally assessing our people practices, policies and programs, marketing approach, and workplace culture._ Why work for PCI Pharma Services? At PCI, we have an uncompromising focus on providing quality and operational excellence and providing the industry leading customer experience. Our people make all of this happen, so providing an industry leading experience for our people is equally as important. By creating an authentic culture of purposeful work, we aspire to be an interesting and fulfilling place for talented individuals to grow careers. We live a philosophy of intentional learning combined with real-life experience supported by a fair and competitive rewards program. We are individuals, teams and a company that believes in our purpose and our approach is simple, the people who work at PCI fuel our business; we don't say no, we figure out how. PCI Pharma Services is an Equal Opportunity Employer/Vet/Disabled
    $69k-113k yearly est. 60d+ ago
  • Director, Facilities - Contract Role

    Madrigal 4.3company rating

    Waltham, MA jobs

    Madrigal is a biopharmaceutical company focused on delivering novel therapeutics for metabolic dysfunction-associated steatohepatitis (MASH), a serious liver disease that can progress to cirrhosis, liver failure, need for liver transplantation and premature mortality. Every member of our Madrigal team is connected by our shared purpose: leading the fight against MASH. Madrigal's medication, Rezdiffra (resmetirom), is a once-daily, oral, liver-directed THR-β agonist designed to target key underlying causes of MASH. Rezdiffra is the first and only medication approved by both the FDA and European Commission for the treatment of MASH with moderate to advanced fibrosis (F2 to F3). An ongoing Phase 3 outcomes trial is evaluating Rezdiffra for the treatment of compensated MASH cirrhosis (F4c). Our success is driven by our people. We are building a dynamic, inclusive, and high-performing culture that values scientific excellence, operational rigor, and collaboration. To support our continued growth, we are strengthening our workforce strategy to ensure we have the right talent, at the right time, in the right way. Director, Commercial Real Estate & Workplace Safety Location: Conshohocken, PA Contract Position Position Summary The Director, Commercial Real Estate & Workplace Safety will oversee the planning, design, and execution of Madrigal's new 65,000-square-foot corporate office buildout in Conshohocken, PA and 53,000 square-foot office in Waltham, PA, ensuring the project is delivered on time, within budget, and aligned with company standards. This leader will also develop and implement comprehensive Environmental Health & Safety (EHS), OSHA compliance, and ergonomics programs to support a safe, sustainable, and productive workplace environment that align with real estate, facilities, and employee experience objectives. This is a hands-on leadership role requiring strong project management, vendor oversight, construction administration, and strategic facilities planning experience within a corporate setting (no labs or manufacturing) Key Responsibilities Real Estate & Construction Project Management Lead the day to day coordination of the corporate offices projects -from design and permitting through construction, occupancy, and post-move stabilization ensuring alignment with overall real estate strategy and design standards established by Executive Director Manage cross functional project activities across architecture, design, engineering, and construction partners to keep deliverables on track and within scope. Oversee project logistics including budget tracking, documentation , RFP coordination, change order processing, maintaining transparency and accountability. Partner with IT, HR, and Finance to ensure technology, workspace design, and budget alignment. Monitor project schedules and milestones, ensuring timely delivery and proactive issue resolution. Coordinate move management, furniture procurement, signage, and occupancy planning. Environmental Health, Safety & Ergonomics Develop and implement a comprehensive EHS program for corporate office operations (no lab/manufacturing scope). Ensure compliance with OSHA, local building codes, and other applicable regulations. Lead ergonomics assessments and programs to enhance employee health, safety, and comfort. Partner with HR and Facilities to drive workplace safety training and emergency preparedness initiatives. Establish metrics, audits, and continuous improvement programs for safety performance. Oversee sustainability and environmental initiatives aligned with corporate responsibility goals, both domestically and internationally Strategic Facilities Planning & Operations Coordinate global real estate operations including lease documentation, renewals, data management, ensuring portfolio accuracy and compliance. Contribute to the evolution of Madrigal's workplace strategy that supports growth, employee experience, and hybrid work models. Support long-term space planning and real estate portfolio management frameworks. Manage relationships with property owners, landlords, and key vendors. Lead workplace policy development around space usage, health & safety, and facilities operations, ensuring quality and accountability Track KPIs for operational efficiency, cost control, and employee satisfaction. Support initiatives that enhance the employee workplace journey through technology, design and services (e.g. visitor management systems, space planning and service request platforms). Qualifications Bachelor's degree in Construction Management, Engineering, Architecture, Facilities Management, or related field; advanced degree preferred. 14+ years of progressive experience in commercial real estate project management and corporate facilities leadership. Proven success delivering large-scale corporate office buildouts (50,000+ sq. ft.) on time and within budget. Strong knowledge of EHS, OSHA compliance, and ergonomics programs. Excellent vendor management, negotiation, and contract administration skills. Demonstrated ability to collaborate across executive, HR, finance, and IT functions. Experience in the biopharma or life sciences corporate sector (non-lab) strongly preferred. Exceptional communication, problem-solving, and leadership skills. PMP or related project management certification preferred. Strong background in space planning, workplace technology and office services programs. Ability to work onsite, 5 days a week, in Conshohocken, PA. All full-time employees receive equity, which reinforces our ownership culture and offers meaningful opportunity for our employees to share in the success they help create. By aligning individual and company performance, we empower employees to think like owners, giving them a stake in the organization. Full-time employees are also eligible for comprehensive benefits, including flexible paid time off, medical, dental, vision and life/disability insurance, and 401(k) offerings (i.e., traditional, Roth, and employer match) in accordance with applicable plans. We also offer additional voluntary benefits like supplemental life insurance, legal services, and other offerings. In addition, we offer mental health benefits through our Employee Assistance Program for employees and their family. The company also provides other benefits in accordance with applicable federal, state, and local laws. We are committed to providing reasonable accommodations for individuals with disabilities throughout the hiring process. If you need assistance, please contact *********************. Madrigal is an Equal Opportunity Employer. All employment is decided on the basis of qualifications, merit, and business need. Applicants will receive consideration for employment without regard to race, ethnicity, color, religion, sex gender identity, sexual orientation, national origin, age, disability, protected veteran or disabled status, or other characteristic protected by applicable federal, state, or local law. Unsolicited resumes from agencies should not be forwarded to Madrigal. Madrigal will not be responsible for any fees arising from the use of resumes through this source. Madrigal will only pay a fee to agencies if a formal agreement between Madrigal and the agency has been established. Applications are being accepted on an ongoing basis and can be submitted through our Madrigal Careers site. Please be aware that we have received reports of individuals misrepresenting themselves as Madrigal Pharmaceuticals' Hiring Managers, seeking to engage with job candidates through fraudulent online advertisements or job posting sites. These unauthorized individuals are using Madrigal's name and logo in an attempt to solicit up-front fees and obtain personal information from interested job candidates. Please know that Madrigal does not conduct interviews via text or in chat rooms; conduct interviews via Skype, RingCentral or solely via telephone; charge candidates an advance fee of any kind (e.g., fees for purchasing equipment); nor does it offer positions of employment without undergoing a thorough recruiting process. Please also note that any correspondence with regard to employment would come from an authorized madrigalpharma.com email address or from an email address from one of our trusted search firm partners. We are aware that incorrect/fraudulent email addresses, with Madrigal misspelled, have been utilized in these most recent fraud attempts. If you receive unsolicited employment offers from people claiming to work for or on behalf of Madrigal, we recommend that you: do not respond to their questions; do not open any attachments; and do not click on any hyperlinks. Any questions regarding the legitimacy of job-related contacts can be directed to ********************* .
    $99k-152k yearly est. Auto-Apply 19d ago
  • Director, Engineering and Maintenance

    Alliance Medical Products 3.7company rating

    Irvine, CA jobs

    "Expect to grow", personally and professionally: At Siegfried, we offer exciting challenges and ample opportunities to showcase your talents. As a trusted and respected partner to the pharmaceutical industry, we uphold the highest standards in safety, quality and sustainability, while fostering a culture that empowers you to thrive. Join a rapidly expanding global company, where diverse perspectives and experiences come together in a collaborative environment. Here, you'll find a workplace that values both collective success and your individual contributions-offering long-term opportunities to grow and make an impact. Your Role: The Director of Engineering and Maintenance will have a vast understanding of engineering, engineering management, manufacturing, quality assurance, automation engineering, maintenance management in pharmaceutical , major CAPEX Site Project approval and execution and maintenance in close collaboration with all the relevant stakeholders. Definition, integration, and coordination of the medium and long-term strategic roadmap in accordance with the strategic vision of the site. Development and facilitation of effective governance structures at the site level, establishing robust processes to track, analyze and monitor measures of operational performance. Must have very strong technical credentials and also have the ability to manage and develop the people and functions that are part of the Engineering department. The Director of Engineering and Maintenance must also work closely with site initiatives for facility, equipment acquisition, site modifications, and qualifications. The role is member of the Site Lead Team. Your Profile: Responsibilities Accomplishment of investment projects according to customer's needs (time, cost, functionality). Interface with Project Management, manufacturing, M&ST and Quality Assurance. Meet agreed upon budget and ensure compliance goals are met. Evaluate critical utilities requirements to support site activities. Accomplishment of investment projects according to customers' needs (time, cost, functionality) Minimization of asset life cycle costs Provide management leadership and oversight to engineers, maintenance, facilities and automation teams Oversee Maintenance, Facilities and Calibration activities. Lead major CAPEX process or equipment projects as required. Provide technical support to the manufacturing group as required. Fulfill responsibilities as a member of the DCR, Deviation and CAPA team. Oversee design and installation of production tooling and equipment. Provide technical support for evaluating and resolving CAPAs. Responsible for department budgeting, equipment purchases, and project planning. Evaluates testing and manufacturing equipment in order to purchase or to make recommendations for purchase of equipment to be used in Manufacturing. To ensure availability of competent, high performing people and managing the engineering talent pool. To stay abreast of current and newly emerging technologies to ensure that appropriate manufacturing techniques are utilized to manufacture high volume, high yield and high value products in aseptic operations. Any and all other duties as assigned by immediate supervisor. Responsible for the maintenance strategy, equipment reliability and KPIs. As a member of SLT, periodically report progress status of key Site actions and key plant initiatives. Ensure robust integration of site strategy with corporate programs. Ensure the sharing and leverage of best practice/ expertise in site and with other plants Required Knowledge, Skills and Abilities Ability to function well in a team environment. Requires extensive interfacing with manufacturers of equipment and vendors of diverse educational backgrounds. Must possess excellent oral and written communication skills. Must interface well cross functionally. Strong well-rounded engineering and project management experience. Superior analytical and computer skills. Capable of using good reason and judgment to make and defend recommendations. Proficient in computer skills, with Windows, Word, Excel, AutoCAD 14, Solid Works, Microsoft Project etc. Required Education and Experience Bachelor of Science Degree in Engineering or equivalent 15 years engineering experience in the pharmaceutical industry 7 or more years' experience in managing an engineering team, and maintenance and facility management. >5 years of GMP experience, including aseptic processes and clean utilities Demonstrated responsibility for CapEx and maintenance budgets > $3M Your Benefits: Siegfried offers competitive pay and benefits including: Medical, dental and vision coverage for employee and dependents Life, short- and long-term disability FSA and HSA 401k with a company match Generous PTO Target base salary -$200,000 - $230,000 Founded in 1873 in Zofingen, Switzerland, Siegfried has grown into a global network of 13 sites across three continents. With a team of more than 3,800 highly skilled professionals, we take the innovations of our pharmaceutical customers to industrial scale and manufacture safe drugs for patients worldwide. As a fully integrated CDMO, Siegfried is one of the few organizations today that can carry out the development and manufacturing of APIs and finished dosage forms under one roof. This unique combination of know-how and experience makes us the most trusted partner in the pharmaceutical industry.
    $200k-230k yearly Auto-Apply 44d ago
  • Director of Engineering/Facilities

    Niowave 3.5company rating

    Lansing, MI jobs

    Summary/objective Oversees and provides direct leadership of Niowave's Engineering/Facilities Department. This role encompasses strategic planning, team leadership, operational optimization, and fostering a culture of safety, quality, and continuous improvement. The Director of Engineering/Facilities is responsible for the leadership and management of a team mechanical engineers and will coordinate with the managers/supervisors of the test engineers, designers, and fabrication personnel within the department for succinct coordination, communication and ultimate success with desired project outcomes and meeting company objectives. Ensures all employees' work in a safe environment and follow all safety rules. People Management roles embrace leadership as a choice, a responsibility, and a remarkable privilege to positively impact the lives of others. Job satisfaction in People Management roles is measured by the synergy you instill in cross-functional team members, enabling them to achieve optimal outcomes. You model a positive learning environment and celebrate the journey as well as the destination. Essential functions Strategic Leadership Develops and implements strategic plans to enhance efficiency, productivity, and quality assurance aligned with organizational objectives. Plans, develops, and oversees implementation of comprehensive operating plans with the goals of continually increased throughput, consistent quality process control and on time delivery. Stays informed about industry trends, best practices, and technological advancements. Develops and manages budgets to ensure financial objectives are met. Serves as a key member of the leadership team in establishing and implementing long-term growth and profitability goals. Team Management Leads and inspires a diverse team of skilled professionals. Establishes and maintains a technical direction and supervisory oversight structure for the department, including career progression and succession planning. Hires, fires, promotes, disciplines, coaches, and awards staff members according to organizational policies. Within the department and across the organization, fosters a culture of respect, safety, quality, and continuous improvement aligning with the mission, vision, and values of the organization. Development Oversight Oversees all aspects of engineering/facilities department. Meets development goals for production and research/development activities in unison with safety, quality, productivity, schedule attainment, and morale. Establishes and maintains strong communication channels and processes with internal customers (Accelerator, Chemistry, Nuclear, etc.) Process Optimization, Quality Assurance, Regulatory Compliance Engages team members in continuous improvement. Identifies and implements process improvements to enhance productivity and reduce waste. Implements and maintains quality control standards to meet/exceed customer expectations for both production and research/development. Collaborates with quality assurance teams to address and resolve any issues promptly as well as creating methods to reduce defects. Ensures manufacturing processes comply with relevant industry standards and regulations. Facilities and Maintenance Provides oversight in the management of the organization's facilities. Establishes and maintains proper staffing of the facilities/maintenance team. Collaborates with other departments (EH&S/People Operations) to align with employee experience objectives as well as state and federal requirements. Competencies Analytical and problem-solving skills; excellent interpersonal, written, and oral communication skills; Organizational and project management skills for self and teams. Strong mechanical aptitude; Strong understanding of manufacturing practices and processes. Able to prioritize and execute tasks in a high-pressure environment. Expertly performs in a team-oriented, collaborative environment. Highly values integrity, professionalism, and confidentiality. Embraces and models the Niowave Values of Teamwork, Courage, Integrity, and Upright Zeal. Understands how to integrate into a new team/organization - appreciates the history of current state, know how and when to make suggestions, as well as using just the right pace to reach the improved future state. Understands their own communication and learning styles, can assess others' styles, and is able to find the right path to connect the two. Required education and experience Bachelor degree in Engineering required; preferred fields of study are: Mechanical or Biomedical Engineering. Engineering experience in both the Research/Development and Production environments. 10+ years of progressive experience in manufacturing/engineering leadership roles 8+ years staff management experience, with demonstrated ability to build cohesive teams, establish career development tracks, and succession planning. Experience applying lean manufacturing principles and practices. Knowledge of CAD design fundamentals and past work with design (Solidworks preferred). Knowledge of fluid dynamics (compressible and incompressible) and of heat transfer in water, gases, etc. and of thermodynamics. Experience with general shop fabrication and assembly and experience interfacing with shop personnel. Hands-on experience utilizing lean manufacturing principles for continuous process improvements (Six Sigma, Lean Manufacturing, 5S) Preferred education and experience Master's degree in Engineering required; preferred fields of study are: Mechanical or Biomedical Engineering. Management of capital construction projects. Lean manufacturing certification. Extensive formalized training in change management, project management, and people management. Physical Demands The physical demands described here are representative of those that must be met by an employee to successfully perform the essential functions of this job. While performing the duties of this job, the employee is occasionally required to stand; walk; sit; use hands to finger, handle, or feel objects, tools or controls; reach with hands and arms; climb stairs; talk and hear; wear safety glasses, goggles, gloves, and Tyvek suit; handle chemicals, solutions, and/or radioactive materials. Ability to lift or move products and supplies, up to 50 pounds. Position Type/Expected Hours of Work/Travel Full-time position. Company's standard operating hours are Monday thru Friday 6a - 6p with production related activities requiring 24/7/365 shifts. This position will have regular working hours during M - F with an expectation of adjusting to work outside of the standards operating hours as needed. Niowave has multiple locations within the Lansing area. Travel between locations is expected in the role. Other duties Please note this job description is not designed to cover or contain a comprehensive listing of activities, duties or responsibilities that are required of the employee for this job. Duties, responsibilities and activities may change at any time with or without notice.
    $92k-144k yearly est. 60d+ ago
  • Director, Data Governance & Engineering, Research

    Vertex Pharmaceuticals 4.6company rating

    Boston, MA jobs

    Vertex is in an exciting time of growth and innovation, and technology and data are valued as strategic assets. We're seeking a visionary Director of Engineering and Data Governance to lead the strategy, planning, and governance of data and custom software solutions for our research, pre-clinical teams, and manufacturing teams. Reporting to the Sr. Director of DSE (Data & Software Engineering) Governance, you will drive innovation, ensure data quality, and enable impactful research through cutting edge data & AI products. This is a high-visibility leadership role with significant influence on Vertex's scientific and business outcomes. Your expertise in understanding engineering capabilities, managing engineering demand, estimating engineering projects, communicating project and function status, and driving governance and standards will be crucial in directing our engineering staff to deliver and support high value business-driven data and software at the right time, with approved resources, and with high quality. Key Duties & Responsibilities Partner with DTE Leadership to develop and execute data and analytics strategy aligned to the research and manufacturing business strategy and develop data and analytics roadmaps to enable the data strategy. Collaborate with cross-functional leaders to identify and deliver high-impact data and software solutions. Oversee the management, documentation, use, and quality assurance processes for prioritized data projects and data assets, including proprietary data sets, third party data, research and pre-clinical data. Establish and enforce data governance standards, frameworks and best practices. Collaborate with stakeholders to define project goals, deliverables, timelines, budgets, and resource requirements. Collaborate with resource managers to source, allocate and assign internal or contingent workers to project and operational activities Monitor project progress, manage risks, and communicate status to senior leadership. Collaborate with cross-functional DTE and business teams, including portfolio management, privacy, security, business engagement, DCS (Data and Computational Sciences), data science teams and HR to ensure data and software development needs are understood and solutions are aligned with prioritized business objectives. Foster a culture of innovation, continuous improvement, and accountability. Knowledge and Skills: Strong knowledge and experience with leading and managing data, AI/ML, reporting and analytics projects and assets for the research, pre-clinical, and manufacturing domains in the biopharmaceutical industry. Knowledge and experience in the research functional area and the related business processes and data. Strong understanding of data management, data governance, data architecture, software engineering, and cloud computing Strong communication and presentation skills, with the ability to communicate technical and non-technical topics to senior leaders and engineering teams. Proven ability to serve as a control function and enforce annual planning agreements by finding ways to say “yes” to prioritized commitments and “no” to lower priority requests Strong understanding and awareness of data privacy, data security and compliance to relevant rules including GxP regulations. Strong knowledge of modern technologies like AI/ML, LLMs, cloud computing, cybersecurity, data platforms like AWS, Snowflake and Databricks Strong project management and resource planning skills. Excellent communication and stakeholder management abilities. Experience with Agile methodologies. Education and Experience Bachelor's degree required (preferably in a technology or engineering discipline). 10+ years' experience working in growing technology roles with at least 6 years in IT leadership positions. 6+ years' experience in a similar governance, planning, or strategy role with a focus on bio pharma #LI-HYBRID Pay Range: $184,000 - $276,000 Disclosure Statement: The range provided is based on what we believe is a reasonable estimate for the base salary pay range for this job at the time of posting. This role is eligible for an annual bonus and annual equity awards. Some roles may also be eligible for overtime pay, in accordance with federal and state requirements. Actual base salary pay will be based on a number of factors, including skills, competencies, experience, and other job-related factors permitted by law. At Vertex, our Total Rewards offerings also include inclusive market-leading benefits to meet our employees wherever they are in their career, financial, family and wellbeing journey while providing flexibility and resources to support their growth and aspirations. From medical, dental and vision benefits to generous paid time off (including a week-long company shutdown in the Summer and the Winter), educational assistance programs including student loan repayment, a generous commuting subsidy, matching charitable donations, 401(k) and so much more. Flex Designation: Hybrid-Eligible Or On-Site Eligible Flex Eligibility Status: In this Hybrid-Eligible role, you can choose to be designated as: 1. Hybrid: work remotely up to two days per week; or select 2. On-Site: work five days per week on-site with ad hoc flexibility. Note: The Flex status for this position is subject to Vertex's Policy on Flex @ Vertex Program and may be changed at any time. #LI-Hybrid Company Information Vertex is a global biotechnology company that invests in scientific innovation. Vertex is committed to equal employment opportunity and non-discrimination for all employees and qualified applicants without regard to a person's race, color, sex, gender identity or expression, age, religion, national origin, ancestry, ethnicity, disability, veteran status, genetic information, sexual orientation, marital status, or any characteristic protected under applicable law. Vertex is an E-Verify Employer in the United States. Vertex will make reasonable accommodations for qualified individuals with known disabilities, in accordance with applicable law. Any applicant requiring an accommodation in connection with the hiring process and/or to perform the essential functions of the position for which the applicant has applied should make a request to the recruiter or hiring manager, or contact Talent Acquisition at ApplicationAssistance@vrtx.com
    $184k-276k yearly Auto-Apply 60d+ ago
  • Manufacturing Engineer/Operational Manager

    Teknion Inc. 4.1company rating

    North Carolina jobs

    Contract furniture manufacturing employs LEAN Manufacturing practices to continuously improve the high mix, low volume nature of this business. Employee engagement is a pillar of our success, and the Engineering Manager is an integral part of this infrastructure. The role is multidisciplinary, requiring knowledge of people development and management, Process Design, Product Design, Quality Assurance, and Machine Maintenance activities within a manufacturing plant and across multiple internal and supply chain facilities. This incumbent is responsible for supporting manufacturing on a day-to-day basis as well as maintaining surveillance over product design and manufacturing processes for the purpose of meeting the quality standard and controlling costs. A key requirement of this position is developing and implementing policies, standards and procedures for new and existing manufacturing methods. The position is accountable for ensuring that the required level of service is provided in the area of manufacturing engineering to all areas of the manufacturing operation. Accountable for leading a multi-disciplinary team to generate and implement cost reduction activities. Lead and maintain a safety program with accountability shared by all employees. Develop and implement plant wide LEAN manufacturing activities Improve product quality using established Quality Control and Assurance methodologies. Accountable for the maintenance of all process related machinery and equipment by ensuring a robust PM process is in place to support day to day operations. Responsible for the management of the Maintenance Dept. and contractors conducting maintenance services Responsible for leading plant Engineering Changes and develop plans to conduct any associated activities coming from such changes. Review, approve and co-ordinate new launch information and activities as provided by design and the new products group. The manufacturing engineering manager must ensure that new launches are introduced as “production friendly” as possible. including, BOM's, routings and work cell designations, all must be reflected upon new products and during day-to-day manufacturing activities. Accountable for reviewing product designs and making recommendations to ensure product costs and manufacturing targets are achieved. In addition, the position is responsible for determining methods, processes, equipment and technologies that enable StudioTK to cost effectively manufacture products. Implementation and monitoring of Manufacturing Quality Assurance processes. Maintain standards as stipulated in ISO 9001 (to be developed) & ISO 14000 where applicable to manufacturing engineering. Determine the appropriate staffing requirements consistent with the department workload. In addition, this incumbent is responsible for directing the selection and training of personnel and overseeing performance management and pay program administration for his/her subordinates. Together with Purchasing and Design Development Engineering, responsible for developing and working with NA & global suppliers to ensure required quality levels are achieved. Maintain a highly motivated and enthusiastic workforce by working with the HR department in the development and implementation of programs that will attract, retain and motivate employees. Ensure that training programs, whether internal or external be taken into account, and if deemed to be of benefit to both the employee and StudioTK, he/she will ensure that employees be provided with opportunity to attend, so as to improve individual skills, set productivity, technical competencies and provide career advancement/succession planning. What is require for this role? University degree in Mechanical or Industrial Engineering. Minimum 10 years experience in a Manufacturing Environment. Three or more years experience in a management position. Good leadership/decision making skills. Excellent Lean Manufacturing knowledge Quality Assurance Methodologies Working knowledge of powder painting, wood finishing, welding and automation. Working knowledge of PFMEA, GD&T, GR&R, Control Plan development, PPAP submissions and APQP activities. Working knowledge of AutoCad and Solidworks platforms Experience in a durable goods, component assembly environment. P.Eng, or eligible for P.Eng. Excellent analytical and problem-solving skills. Excellent time management skills and the ability to handle several tasks simultaneously. Good interpersonal skills. Ability to travel locally and internationally. This Opportunity Offers Competitive Salary Excellent Health Benefits 401K An exciting work environment Studio TK is an equal opportunity employer and is committed to diversity and inclusion. We offer full time employment with competitive compensation and benefit packages including medical, dental, optical, and 401k. Studio TK is committed to supporting a culture of diversity and accessibility across the organization. IT is our priority to remove barriers to provide equal access to employment. A Human Resources Representative will consult with applicants contacted to participate at any stage of the recruitment process. Equal Opportunity Employer This employer is required to notify all applicants of their rights pursuant to federal employment laws. For further information, please review the Know Your Rights notice from the Department of Labor.
    $81k-104k yearly est. Auto-Apply 60d+ ago
  • Maintenance and Facilities Manager

    Engineered Medical Systems 3.4company rating

    Bartlett, TN jobs

    The primary responsibility of this position is to provide operational support and leadership and direction the maintenance and facility personnel. Responsibility includes overall facility support for all functions and operations and to assist in project management as needed for capital purchases, facility expansion and/or remodel. This position also ensures compliance with all required state, local, federal and regulatory agencies and bodies in the oversight of the facility and maintenance for all buildings. The Maintenance & Facilities Manager will create and maintain a Maintenance Strategy that supports and aligns with EMS goals and objectives. This position is accountable for the execution of this strategy, both short and long term. Responsibilities Manage the overall day-to-day activities of the Maintenance Technicians. Support operational goals and metrics for Safety, Quality, Delivery, Productivity/Cost and People. Inventory Management - Spare parts, rebuilds, etc. Ensure that safety rules and regulations are well known, understood and applied and equipment meets safety guidelines and regulations. Initiates, implements, and manages the Maintenance Work Order/Preventative Maintenance System and Computerized Maintenance Management System (CMMS/Limbel) to prioritize, plan, and schedule maintenance work efficiently while minimizing maintenance cost and equipment downtime, as well as identify process improvement opportunities. Monitoring, management and service of HVAC and MEP for both facilities. Respond to all unplanned and emergency downtime on equipment as required to resume operations efficiently and quickly. Development and ownership of the maintenance & facilities budget. Hiring, coaching, developing and delivering discipline as needed within team. Identify and manage outside independent contractors as needed for projects and/or service support. May assist in the preparation of bid specifications for work to be done by outside contractors. Participate in strategic planning/project management for future production capacities, capabilities and other facility needs and requirements. Performs other duties by coordinating work with outside inspectors, in compliance with local regulations. Support the EMS Quality Policy and Quality Objectives. Perform Other Duties as assigned. Requirements A minimum of a High School diploma or equivalent and 7+ years of related experience. 3+ years of experience leading a team. Experience developing maintenance plan preferred. Experience with CNC machining equipment, facilities troubleshooting and preventative maintenance required. Works well under pressure. Experience in a regulated environment preferred (medical device, aerospace, etc.) Ability to think critically and analytically and have a strong attention to detail. Strong understanding of compliance and safety regulations relevant to industry as well as state, local, federal and regulatory bodies. Demonstrate leadership, problem solving and communication skills to guide the maintenance team and partner with other department leaders. Provide 24/7-365 maintenance and facility coverage through team and/or outside contractors. Must be able to speak, read and write in the English language. Restrictions Ability to bend, stoop, grip, reach and lift up to 40 lbs. on a repetitive basis. Able to stand the majority of the shift to perform duties. Search Firm Representatives Please read carefully EMS is not accepting unsolicited assistance from search firms for our current employment opportunities. Please, no phone calls or emails. Please read carefully before applying I certify that all the information on this application, my resume, or any supporting documents I may present during any interview is and will be true, complete and accurate, to the best of my knowledge. I understand that any falsification, misrepresentation, or omission of any information may result in disqualification from further consideration for employment or, if employed, disciplinary action, up to and including immediate dismissal, regardless of when such information is discovered. The Company considers this Application for Employment to be a part of the personnel record. THIS COMPANY IS AN AT-WILL EMPLOYER WHERE ALLOWED BY APPLICABLE STATE LAW. THIS MEANS THAT REGARDLESS OF ANY PROVISION IN THIS APPLICATION, IF HIRED, THE COMPANY OR I MAY TERMINATE THE EMPLOYMENT RELATIONSHIP AT ANY TIME, FOR ANY REASON, WITH OR WITHOUT CAUSE OR NOTICE. NOTHING IN THIS APPLICATION OR IN ANY DOCUMENT OR STATEMENT, WRITTEN OR ORAL, SHALL LIMIT THE RIGHT TO TERMINATE EMPLOYMENT AT-WILL. I UNDERSTAND THAT NO COMPANY EMPLOYEE OR REPRESENTATIVE HAS THE AUTHORITY TO ENTER INTO A CONTRACT REGARDING DURATION OF TERMS AND CONDITIONS OF EMPLOYMENT OTHER THAN THE PRESIDENT/CEO OF THE COMPANY AND THEN ONLY BY MEANS OF A WRITTEN CONTRACT SIGNED BY THE PRESIDENT/CEO. I authorize the Company and/or its agents to confirm all statements contained in this application and/or resume as it relates to the position I am seeking, to the extent permitted by federal, state, or local law. Federal law and some states require a separate disclosure and consent when obtaining background reports from a consumer reporting agency. I understand I will be asked to complete any requisite consent forms for the background check which may be required by federal, state and/or local law. I agree to sign these forms and understand that my offer of employment may be conditional upon the background check. I AUTHORIZE AND CONSENT TO, WITHOUT RESERVATION, ANY PARTY OR AGENCY CONTACTED BY THIS EMPLOYER (INCLUDING ANY AND ALL PRIOR EMPLOYERS OF MINE) TO FURNISH INFORMATION REGARDING MY PREVIOUS EMPLOYMENT HISTORY AND/OR ANY OF THE ABOVE-MENTIONED INFORMATION. I hereby release, discharge, and hold harmless, to the extent permitted by federal, state, and local law, any party delivering information to the Company pursuant to this authorization from any liability, claims, charges, or causes of action which I may have as a result of the delivery or disclosure of the above requested information. I hereby release from liability the Company for seeking such information and all other persons, corporations, or organizations furnishing such information. If hired by the Company, I understand that I will be required to provide genuine documentation establishing my identity and eligibility to be legally employed in the United States by this Company as required by the Immigration Reform and Control Act of 1986. I also understand this Company employs only individuals who are legally eligible to work in the United States.
    $37k-62k yearly est. 9d ago
  • Director of Process Engineering

    TTM 4.2company rating

    New York jobs

    TTM Technologies, Inc. - Publicly Traded US Company, NASDAQ (TTMI) - Top-5 Global Printed Circuit Board Manufacturer TTM Technologies, Inc. is a leading global manufacturer of technology products, including mission systems, radio frequency (“RF”) components, RF microwave/microelectronic assemblies, and technologically advanced printed circuit boards (“PCB”s). TTM stands for time-to-market, representing how TTM's time-critical, one-stop design, engineering and manufacturing services enable customers to reduce the time required to develop new products and bring them to market. Additional information can be found at *********** The Director of Process Engineering is responsible for providing leadership and direction to the process engineering group engaged in the manufacturing/test for complex electronics, including SMT, Wirebond, Die Attach, environmental testing and electrical testing. Duties and Responsibilities: Responsible for setting the engineering vision and strategy to meet overall long- and short-term company goals. This includes definition and communication of goals, key objectives, and metrics. Ensures that process engineering meets the business needs of the company as they relate to capabilities, processes, technologies, and capacity. Stays current with related manufacturing trends. Develops and enforces a culture of strong engineering discipline including robust process definition, extensive testing prior to production implementation, robust change management processes, clear and complete manufacturing instructions, statistical process monitoring and control, proactive error proofing, etc. Develops and maintains tactical and strategic plans to achieve the proper balance of process development and process maintenance. Ensures metrics are in place to monitor performance against the goals and takes appropriate corrective actions as required. Ensures that structured problem-solving techniques are used and that adequate validation is performed for any issues being address or changes being made. Prioritizes and coordinates resolution of problems related to equipment, safety, product, quality or process issues. Ensures adequate equipment capacity and process capability. Responsible to for Capital Expenditure tracking and qualification of new equipment. Implements plans to improve process capability using statistical analysis. Interfaces with customers on product design, product needs and product issues. Root cause analysis of issues associated with the plant. Evaluation of equipment through DOE and capability testing. Maintain the necessary communications and effective relationships with other company functions required to support the operation. Supports business development proposals and engineering efforts by providing technical resources necessary. Key member of site Technical Review Board (TRB). Develops and maintains an effective process engineering organization through the selection, training, development, compensation and motivation of all personnel assigned to their organization. Recommends and approves organizational structures and staffing requirements in support of company business objectives. Complies with laws, company policy and procedures including but not limited to Equal Opportunity Employment, Affirmative Action, Business Ethics, EPA, OSHA and other federal, state and local regulatory agencies. Other duties as required. Essential Knowledge and Skills: Able to exhibit a professional manner in dealing with superiors, colleagues, and customers Thorough knowledge of process improvement methodologies to include SPC, Root Cause Analysis, Design of Experiments, and Problem Solving techniques Knowledgeable on labor issues including safety, security, employee relations, scheduling and training Experience with electronics manufacturing processes and AS9100 requirements Ability to read, write and communicate in English to the degree necessary to perform the job Education and Experience: Bachelor of Science degree in Engineering or related science required 10 years' experience in engineering processes in electronics manufacturing industry technology with prior management experience, preferably in the Aerospace & Defense market #LI-PG1 Compensation and Benefits: TTM offers a variety of health and well-being benefit programs. Benefit options include medical, dental, vision, 401K, Flexible Spending Account, Health Savings Account, accident benefits, life insurance, disability benefits, paid vacation & holidays. Benefits are available 1st of the month following date of hire. Compensation for roles at TTM Technologies varies depending on a wide array of factors including but not limited to the specific office location, role, skill set and level of experience. As required by local law, TTM provides a reasonable range of compensation for roles that my be hired in New York, California and Colorado. For California-based roles, compensation ranges are based upon specific physical locations. Export Statement: Must comply with TTM Export Control Policies and Procedures and all applicable laws including ITAR, EAR and OFAC including but not limited to: a) being able to identify ITAR product on the manufacturing floor and understand that access to these products and related technical data is restricted to only US Citizens and US Permanent Residents; b) recognition of Foreign Person visitors by badge differentiation; c) understand and follow authorization procedures for bringing foreign visitors into facilities (VAL); d) understand the Export and ITAR requirements for shipments leaving the US; e) manage vendor approvals for ITAR manufacturing and services. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, citizenship, disability or protected veteran status.
    $134k-193k yearly est. Auto-Apply 58d ago
  • Manager, Mechanical Engineering & Design

    Niowave 3.5company rating

    Lansing, MI jobs

    Summary/objective The Mechanical Engineering and Design Manager role encompasses leadership, subject matter expertise, operational excellence, and fosters a culture of safety, quality, continuous improvement, and the ideal staff member experience. The Mechanical Engineering and Design Manager provides management and direction for mechanical engineering and design personnel, driving R&D prototyping and commercial equipment production to meet the expanding needs of the radioisotopes business. They will drive results and team reputation through collaborative project management methodologies, strong technical review and decision making processes, role modelling the desired behaviors, and leading production efficiency in our machine design and fabrication teams. People Management roles embrace leadership as a choice, a responsibility, and a remarkable privilege to positively impact the lives of others. Job satisfaction in a People Management role is measured by the synergy you instill in cross-functional team members, enabling them to achieve optimal outcomes. You model a positive learning environment and celebrate the journey as well as the destination.
    $94k-132k yearly est. 60d+ ago
  • Sr Facilities Engineer

    Uswm, LLC 4.4company rating

    Philadelphia, PA jobs

    The Sr. Facilities Engineer is responsible for ensuring that all process equipment and critical utilities are maintained in a qualified, calibrated, and compliant state to support GMP manufacturing and overall facility operations. This role independently performs and oversees complex process equipment and utility calibrations, troubleshooting, and repairs while ensuring adherence to cGMP, regulatory, and company quality standards. The position serves as a subject matter expert for process equipment reliability, supporting cross-functional root cause investigations related to equipment failures, deviations, and performance issues. Responsibilities include diagnosing technical problems, developing corrective and preventive actions (CAPAs), scheduling and coordinating third-party calibration and service providers, and ensuring timely execution of maintenance and calibration activities. In addition, the Sr. Facilities Engineer drives continuous improvement initiatives to enhance the robustness, efficiency, and compliance of the calibration and maintenance programs, advancing the organization toward a higher level of commercial readiness. This includes optimizing calibration strategies, improving documentation and data integrity, strengthening preventive maintenance programs, and supporting equipment lifecycle management to ensure long-term operational reliability and inspection readiness. DUTIES AND RESPONSIBILITIES: Partner with CMC, Manufacturing, Quality, and Facilities teams to understand core business objectives and ensure calibration and maintenance strategies align with operational, regulatory, and commercial readiness requirements. Own and oversee the utility and process equipment calibration program in compliance with cGMP and GDP requirements, ensuring a high level of equipment reliability, data integrity, and continuous inspection readiness. Evaluate the effectiveness of individual equipment calibration strategies and collaborate with asset owners and Quality to implement risk-based improvements that enhance performance and compliance. Serve as the technical lead for identifying, investigating, and resolving calibration and equipment performance deficiencies using structured root cause analysis and sound engineering judgment. Initiate and actively participate in GMP investigations, deviations, CAPAs, and change control processes related to calibration, maintenance, and equipment performance. Develop, maintain, and execute department self-audit programs for equipment repair and maintenance activities, including: Creating audit checklists Conducting audits Preparing reports Recommending and tracking corrective actions Manage and forecast calibration-related budgets by tracking expenses, analyzing trends, and supporting annual maintenance cost planning. Supervise and manage third-party service providers, including: Scheduling and coordinating services Escorting vendors in GMP and cleanroom environments Ensuring work is performed in accordance with US WorldMeds EHS, GMP, and quality requirements Verifying documentation is complete, accurate, and recorded at the time of service Align calibration and maintenance activities with manufacturing schedules to ensure work is completed before due dates while minimizing production impact. Independently review and analyze equipment history, trends, and performance data to identify reliability risks and recommend improvements to calibration and maintenance strategies. Identify, procure, and maintain inventories of critical spare parts, calibration standards, and standby equipment necessary to support maximum operational capacity and system reliability. Respond to equipment, building, and utility alarms after hours on a rotational basis, including acknowledging alarms through the BMS and supporting emergency troubleshooting and resolution. Participate in the evaluation of Facilities-related process gaps and contribute to cross-functional efforts to close compliance, efficiency, and reliability gaps. Research industry best practices, engage in professional networking, and apply technical expertise to develop and recommend commercial-level calibration and maintenance process improvements. Assess the effectiveness of implemented improvements and report findings, trends, and recommendations to asset owners and leadership. Ensure all calibration records are organized, complete, accurate, and maintained in strict accordance with GDP requirements. Perform all activities in compliance with applicable cGMP regulations and relevant FDA, USP, and ISPE guidelines. Champion GMP compliance, data integrity, and maintenance best practices to support a best-in-class calibration and reliability program. Develop, revise, and maintain SOPs, work instructions, and technical documentation related to calibration and maintenance processes. Serve as the internal audit lead for Facilities processes related to equipment maintenance and calibration, including gap analysis, documentation of findings, and recommendations for corrective actions. Provide technical mentorship and guidance to junior engineers, technicians, and cross-functional partners as needed. Perform additional duties and special projects as assigned in support of a rapidly growing and evolving organization. QUALIFICATIONS: Bachelor's degree in Engineering required with 7-10+ years of experience in pharmaceutical or biotech manufacturing, including process equipment support, calibration, and GMP compliance. Advanced degree preferred. Demonstrated commitment to precision, accuracy, and high-quality workmanship in all technical and compliance-related activities. Strong written and verbal communication skills with a proven ability to work effectively in highly collaborative, team-based environments. Excellent analytical, troubleshooting, and critical-thinking skills, with hands-on experience diagnosing and resolving equipment and utility performance issues. Proven ability to partner effectively with both technical and non-technical stakeholders across all levels of the organization. High-energy, results-oriented professional with a confident yet approachable demeanor and a strong bias for action. Availability to participate in a scheduled rotational on-call program to respond to after-hours equipment and utility emergencies. Experience using computerized maintenance management systems (CMMS), such as Blue Mountain or equivalent platforms. This role is fully on-site, requiring five days per week in-office presence. Formal training and/or certification in metrology are strongly preferred. Experience within the biopharmaceutical or pharmaceutical manufacturing industry. Hands-on calibration experience across a broad range of process equipment and utility systems in a GMP-regulated manufacturing environment. Working knowledge of GMP Quality Management Systems, including deviations, investigations, CAPAs, and change controls. Strong ability to analyze raw calibration and performance data, interpret results, and determine appropriate corrective actions. Proven ability to consistently apply standardized work methods with a high level of precision to ensure data integrity and quality outcomes. Experience completing and maintaining GMP-compliant documentation related to calibration, maintenance, and equipment activities. Demonstrated ability to organize and manage calibration schedules using Excel, CMMS, or other electronic tools to ensure all work is completed within required due dates. Exceptional organizational skills and adaptability, with the resilience to manage conflicting priorities and rapidly changing schedules. Ability to work independently with minimal supervision while also thriving in a collaborative team environment. Experience working in and gowning for GMP cleanroom environments. Highly collaborative mindset with strong alignment to business objectives, organizational values, and strategic priorities. Prior experience supporting complex biotechnology and/or pharmaceutical manufacturing operations. Working knowledge of AutoCAD or similar engineering drawing software preferred. COMPETENCIES: Adaptability - Adapts to changes in the work environment; Manages competing demands; Changes approach or method to best fit the situation; Able to deal with frequent change, delays, or unexpected events. Analytical - Synthesizes complex or diverse information; Collects and researches data; Uses intuition and experience to complement data; Designs workflows and procedures. Attendance/Punctuality - Is consistently at work and on time; Ensures work responsibilities are covered when absent; Arrives at meetings and appointments on time. Business Acumen - Understands business implications of decisions; Displays orientation to profitability; Demonstrates knowledge of market and competition; Aligns work with strategic goals Computer Skills - Skilled with computers; Takes advantage of new technology; Learns new tools quickly; Uses technology to enhance job performance. Conflict Management - Good listener; Committed to finding solution to problems; Works well with people. Customer Service - Manages difficult or emotional customer situations; Responds promptly to customer needs; Solicits customer feedback to improve service; Responds to requests for service and assistance; Meets commitments. Decision Making - Able to reach decisions; Takes thoughtful approach when considering options; Seeks input from others; Makes difficult decisions; Exhibits sound and accurate judgment; Supports and explains reasoning for decisions. Dependability - Follows instructions, responds to management direction; Takes responsibility for own actions; Keeps commitments; Commits to long hours of work when necessary to reach goals; Completes tasks on time or notifies appropriate person with an alternate plan. Design - Generates creative solutions; Translates concepts and information into images; Uses feedback to modify designs; Applies design principles; Demonstrates attention to detail. Diversity - Demonstrates knowledge of EEO policy; Shows respect and sensitivity for cultural differences; Educates others on the value of diversity; Promotes a harassment-free environment; Builds a diverse workforce. Ethics - Treats people with respect; Keeps commitments; Inspires the trust of others; Works with integrity and ethically; Upholds organizational values. Interpersonal Skills - Focuses on solving conflict, not blaming; Maintains confidentiality; Listens to others without interrupting; Keeps emotions under control; Remains open to others' ideas and tries new things. Initiative - Volunteers readily; Undertakes self-development activities; Seeks increased responsibilities; Takes independent actions and calculated risks; Looks for and takes advantage of opportunities; Asks for and offers help when needed. Innovation - Displays original thinking and creativity; Meets challenges with resourcefulness; Generates suggestions for improving work; Develops innovative approaches and ideas; Presents ideas and information in a manner that gets others' attention. Judgment - Displays willingness to make decisions; Exhibits sound and accurate judgment; Supports and explains reasoning for decisions; Includes appropriate people in decision-making process; Makes timely decisions. Motivation - Sets and achieves challenging goals; Demonstrates persistence and overcomes obstacles; Measures self against standard of excellence; Takes calculated risks to accomplish goals. Oral Communication - Speaks clearly and persuasively in positive or negative situations; Listens and gets clarification; Responds well to questions; Demonstrates group presentation skills; Participates in meetings. Organizational Support - Follows policies and procedures; Completes administrative tasks correctly and on time; Supports organization's goals and values; Benefits organization through outside activities; Supports affirmative action and respects diversity. Planning/Organizing - Prioritizes and plans work activities; Uses time efficiently; Plans for additional resources; Sets goals and objectives; Organizes or schedules other people and their tasks; Develops realistic action plans. Professionalism - Approaches others in a tactful manner; Reacts well under pressure; Treats others with respect and consideration regardless of their status or position; Accepts responsibility for own actions; Follows through on commitments. Problem Solving - Identifies and resolves problems in a timely manner; Gathers and analyzes information skillfully; Develops alternative solutions; Works well in group problem solving situations; Uses reason even when dealing with emotional topics. Project Management - Develops project plans; Coordinates projects; Communicates changes and progress; Completes projects on time and budget; Manages project team activities. Quality - Demonstrates accuracy and thoroughness; Looks for ways to improve and promote quality; Applies feedback to improve performance; Monitors own work to ensure quality. Quantity - Meets productivity standards; Completes work in timely manner; Strives to increase productivity; Works quickly. Quality Management - Looks for ways to improve and promote quality; Demonstrates accuracy and thoroughness Strategic Thinking - Develops strategies to achieve organizational goals; Understands organization's strengths & weaknesses; Analyzes market and competition; Identifies external threats and opportunities; Adapts strategy to changing conditions. Safety and Security - Observes safety and security procedures; Determines appropriate action beyond guidelines; Reports potentially unsafe conditions; Uses equipment and materials properly. Teamwork - Balances team and individual responsibilities; Exhibits objectivity and openness to others' views; Gives and welcomes feedback; Contributes to building a positive team spirit; Puts success of team above own interests; Able to build morale and group commitments to goals and objectives; Supports everyone's efforts to succeed. Technical Skills - Assesses own strengths and weaknesses; Pursues training and development opportunities; Strives to continuously build knowledge and skills; Shares expertise with others. Written Communication - Writes clearly and informatively; Edits work for spelling and grammar; Varies writing style to meet needs; Presents numerical data effectively; Able to read and interpret written information. PHYSICAL DEMANDS: Frequently required to stand Frequently required to walk. Frequently required to sit. Frequently required to talk or hear. Occasionally required to lift light weights (less than 30 pounds) Specific vision abilities required for this job include: close vision, color vision and ability to adjust or focus WORK ENVIRONMENT: The noise level in the work environment usually is quiet. The above is intended to describe the general content of and requirements for the performance of this job. It is not to be construed as an exhaustive statement of duties, responsibilities or requirements. Nothing in this job description restricts management's right to assign or reassign duties and responsibilities to this job at any time.
    $89k-128k yearly est. Auto-Apply 9d ago
  • SR AD, Global Facilities Engineering

    Boehringer Ingelheim Group 4.6company rating

    Gainesville, FL jobs

    As an employee of Boehringer Ingelheim, you will actively contribute to the discovery, development, and delivery of our products to our patients and customers. Our global presence provides opportunity for all employees to collaborate internationally, offering visibility and opportunity to directly contribute to the companies' success. We realize that our strength and competitive advantage lie with our people. We support our employees in several ways to foster a healthy working environment, meaningful work, mobility, networking, and work-life balance. Our competitive compensation and benefit programs reflect Boehringer Ingelheim's high regard for our employees. As an integral member of the Site Leadership team, the Senior Associate Director, GFE and Engineering & Technology has end to end accountability for the Global Facilities & Engineering (GFE) and Engineering & Technology (E&T) functions. This role is responsible for executing global strategy and regional action plans for , and for managing / optimizing site performance. The Local Head of GFE / E&T ensures: Pursuit of GFE / Business Unit (BU) strategy from a Site Services perspective, incl. adherence to global standards for GFE and local regulations. Tactical leadership of capital investment budgeting, asset management and engineering project execution. Execution of fast, agile, and high-quality Site Services following common standards. Reporting to Head of GFE and Head of BU Global Engineering (GE) on local & site-specific regulations compliance, & actions to protect BI's reputation. Proactive management of the organizational risks on site. Safety and security of BI employees and assets. Leadership, people development and employee reviews. The SR AD, GFE and E&T is accountable to execute and adhere to global GFE solutions across site GFE / E&T functions, consistent with BU requirements. This role has end-to-end accountability to safeguard effective solution delivery and performance management for local GFE / E&T functions. Duties & Responsibilities Leads, oversees, and directs these functions: Engineering (including Process Engineering, Automation, Maintenance & Digitalization), Real Estate & Facility Management, Environmental, Safety, Sustainability and Security. Accountability for budget oversight, capital project management, sustainability targets, and facility, plant, utility, environmental & security operations. Aggregates & approves budget proposals from site GFE / E&T functions & communicates to the regional level. Implements priorities and targets as defined by Global/Regional Head of GFE and Head of BU GE. Ensures local targets are coherent for GFE / E&T functions (no conflicting targets). Safeguards effective solution delivery by aggregating and reporting GFE and E&T function performance, quality, and compliance to the regional / global level. Develops and executes key technical engineering strategies within production areas to improve critical process efficiency / performance. Ensures process improvement projects are incorporated into strategic CapEx and OpEx plans / budgets. Develops & effectively manages CapEx Project execution based on site, regional & global BU strategy. Ensures CapEx management meets Corp. standards & procedures. Collaborates with GFE Project Management for Strategic Projects (over 50M EUR) Oversees execution of selected services on site according to defined standards & performance levels. Ensures best practice sharing across GFE/E&T functions (if applicable). Reviews & aligns local or BU-specific adaptations of global concepts, standards, and processes with Regional Head of GFE / Head of BU GE when required. Accountable to ensure all regulatory and (site-specific) legal requirements are being followed. Ensures safety and security of BI assets and employees as well sustainability of services and facilities. Oversees Talent Management and employee lifecycle for GFE/E&T functions on site level. Requirements University degree in the respective field of responsibility. Five to ten (5-10) years of experience on a site in a leading position. Three to five (3-5) years of experience in one or more GFE and E&T functions present at the site. Proven track record in site operations. Routine exposure to inspections / audits (agencies, customers, suppliers, etc.) with successful outcomes. Proven team & individual performance management, including coaching and development, leading to consistent delivery of targeted results. Visionary leadership competencies & passionate team player (also in virtual setting) Service orientation and customer focus. Multi-cultural awareness and understanding. Internal / external networking across functions and different executive levels. Eligibility Requirements: Must be legally authorized to work in the United States without restriction. Must be willing to take a drug test and post-offer physical (if required). Must be 18 years of age or older. Desired Skills, Experience and Abilities
    $96k-120k yearly est. 60d+ ago
  • Sr. Facilities Mgt Coord

    Endo 4.7company rating

    Webster Groves, MO jobs

    Why Us? At Par Health, we believe great healthcare is built on getting the essentials right. We're looking for passionate, talented individuals who share our commitment to improving lives. With 4,000+ team members worldwide, we lead with pride and purpose-prioritizing quality and safety while fostering a culture of continuous improvement, accountability, and teamwork. Elevating the Essentials isn't just our tagline, it's the higher standard we live by every day. Summary This position will be responsible for shipping, receiving, hazardous waste pickup and shipping, mail sorting & delivery, glassware washing, coordinating and interfacing with outside vendors. This position is also responsible or purchasing office and building supplies and services using a company provide purchasing card. This position is located at the Business Unit Headquarters, Webster Groves, MO. Job Description SUMMARY OF POSITION: This position will be responsible for shipping, receiving, hazardous waste pickup and shipping, mail sorting & delivery, glassware washing, coordinating and interfacing with outside vendors. This position is also responsible or purchasing office and building supplies and services using a company provide purchasing card. This position is located at the Business Unit Headquarters, Webster Groves, MO. ESSENTIAL FUNCTIONS: Manage all aspects of shipping/receiving functions in accordance with DOT/IOTA regulations, DEA requirements and CGMP guidance. Collaborate with all Webster Groves personnel for all shipping/receiving goods to include but not limited to Clinical Trials, Bulk Commercial shipments, Manufacturing samples, and critical/essential building supplies. Procure, Interface and coordinate services and goods with outside vendors including but not limited to uniforms, coffee, office supplies, pest control, contract document shredding, industrial and lab gases, etc. Maintain site chemical inventories through cataloging, tracking, report generation, and ensuring recorded disposal of chemicals that enter the facility through CISPRO, a chemical database system. Electronic receiving of items purchased utilizing the BPICS & JDE purchasing systems. Direct oversite of all hazardous waste operation generated from the Webster Goves to ensure proper collection, storage and disposal within RCRA regs. Develop waste profiles. Secure approval for all hazardous waste disposal. Reviewing and approving hazardous waste manifests generated by Heritage Environmental. Serve as Site Maximo administrator creating workorders, adding new assets and job plans, and all changes within Maximo related to Webster Groves. Collaborate with Trade Compliance and Project Management teams to ensure proper documentation and all logistics of all imports and exports. Manage inventory of critical equipment at offsite storage for Operations. Performing facility inspections as assigned included but not limited to safety showers, fire extinguishers, and housekeeping. Support Webster Groves MFG inventory management including BPCS transactions and shop order maintenance. DEPARTMENT SPECIFIC/NON-ESSENTIAL FUNCTIONS: Other duties as assigned with or without accommodation. MINIMUM REQUIREMENTS: Education required/ preferred: High School Diploma or equivalent. AA degree preferred Experience: 6-8 years hands on experience in transportation, shipping and receiving. Maintain DOT, IATA and RCRA certifications by attending outside training Preferred Skills/Qualifications: Proficient in Microsoft Word, Excel and Outlook. Excellent verbal and written communication skills Knowledge of hazardous material shipping and receiving Ability to interface with outside vendors. Ability to service internal customers needs in a timely manner. Knowledgeable in CisPro, BPICS, Maximo, Coupa, Trackwise and DART Skills/Competencies: Excellent interpersonal skills Ability to interact effectively with various personalities at all levels. Ability to make decisions on the fly with minimal information ORGANIZATIONAL RELATIONSHIPS/SCOPE: Internal contacts include all levels of the organization from lab worker to VP's. External contacts include contractors from all different trades, equipment vendors and service providers. WORKING CONDITIONS: Working conditions range from normal office environment, shipping receiving dock, R&D laboratory. Ability to lift 50 pounds. Move items on two wheeled dollies, carts and etc safely. Flexible work schedule required Ability to work over 40 hours per week on occasions as needed. DISCLAIMER: The above statements are intended to describe the general nature and level of work being performed by employees assigned to this classification. They are not intended to be construed as an exhaustive list of all responsibilities, duties and skills required of employees assigned to this position. EEO Statement: We comply with all applicable federal, state, and local laws prohibiting discrimination and harassment, and provides equal employment opportunities (EEO) to all employees and applicants for employment without regard to race, color, religion, gender, sexual orientation, gender identity, national origin, age, disability, veteran status, or genetic information, or any other classification protected by federal, state or local law. This policy applies to all terms and conditions of employment, including recruiting, hiring, placement, promotion, termination, layoff, recall, transfer, leaves of absence, compensation and training.
    $92k-126k yearly est. Auto-Apply 19d ago
  • Project Manager, Engineering Projects

    Capsugel Holdings Us 4.6company rating

    Bend, OR jobs

    Today, Lonza is a global leader in life sciences operating across five continents. While we work in science, there's no magic formula to how we do it. Our greatest scientific solution is talented people working together, devising ideas that help businesses to help people. In exchange, we let our people own their careers. Their ideas, big and small, genuinely improve the world. And that's the kind of work we want to be part of. Lonza Pharma & Biotech has an exciting opportunity for a Project Manager, Engineering Projects at our Bend, Oregon site. In this role, you will lead complex capital projects that shape the future of pharmaceutical manufacturing and ensure compliance with the highest safety and quality standards. What you will get An agile career and dynamic working culture. An inclusive and ethical workplace. Compensation programs that recognize high performance. Medical, dental, and vision insurance. Access to global benefits: *************************************** What you will do Deliver site capital projects within scope, budget, and schedule. Lead projects from concept through design, construction, and qualification. Ensure compliance with safety, quality, and regulatory standards. Manage contractors and oversee procurement processes. Identify and mitigate project risks. Coordinate engineering and GMP documentation handover. Mentor team members in project management best practices. What we are looking for 5+ years of engineering experience in the pharmaceutical industry. 5+ years of project management experience. Strong knowledge of cGMP and regulatory compliance. Proficiency with Microsoft Project, AutoCAD, SAP, and CMMS systems. Ability to lead cross-functional teams and manage contractors. Excellent communication and problem-solving skills. Bachelor's degree in engineering or related field. Every day, Lonza's products and services have a positive impact on millions of people. For us, this is not only a great privilege, but also a great responsibility. How we achieve our business results is just as important as the achievements themselves. At Lonza, we respect and protect our people and our environment. Any success we achieve is no success at all if not achieved ethically. People come to Lonza for the challenge and creativity of solving complex problems and developing new ideas in life sciences. In return, we offer the satisfaction that comes with improving lives all around the world. The satisfaction that comes with making a meaningful difference. Lonza is an equal opportunity employer. All qualified applicants will receive consideration for employment without regard to race, religion, color, national origin, sex, sexual orientation, gender identity, age, status as a qualified individual with disability, protected veteran status, or any other characteristic protected by law.
    $80k-122k yearly est. Auto-Apply 32d ago
  • Project Manager, Engineering

    Fenwal 4.3company rating

    Melrose Park, IL jobs

    Job SummaryThe Engineering Project Manager leads and coordinates cross-functional projects to ensure delivery on time, within scope, and on budget. The role requires a balance of technical knowledge, structured project management, and leadership skills to plan, organize, and execute projects while maintaining clear communication with stakeholders.Responsibilities Project Management Plan, structure, and execute projects from initiation to completion, ensuring timelines, resources, and deliverables are aligned. Apply project management methodologies to ensure effective execution and risk management. Define clear project goals, milestones, and timelines, and implement structure from the start. Technical Leadership Leverage knowledge of product properties (aseptic, TS, bags, syringes, etc.), manufacturing technologies, and pharma execution strategies. Support design reviews, qualification activities, and technical decision-making. Drive structured problem solving and simplify complex challenges into actionable steps. Business & Financial Management Oversee project budgets, ensure cost control, and deliver within approved financial parameters. Monitor and report on project performance to stakeholders, including senior leadership. Team Leadership & Collaboration Motivate, guide, and align cross-functional teams while managing conflicts and facilitating decision-making. Communicate clearly and transparently with all stakeholders, including internal teams, customers, and senior leadership teams (SLT). Ensure every voice is heard and considered in the decision-making process. Continuous Improvement Encourage team self-reflection and learning, fostering a culture of continuous improvement. Identify and implement process enhancements to improve efficiency and effectiveness. Travel Expecting 20-30% travel based on projects All employees are responsible for ensuring the compliance to company documents, programs and activities related to the Health, Safety, Environment, Energy, and Quality Management Systems, as per your roles and responsibilities. Additional Information We offer an excellent salary and benefits package including medical, dental and vision coverage, as well as life insurance, disability, 401K with company contribution, and wellness program. Fresenius Kabi is an Equal Opportunity/Affirmative Action employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, national origin, citizenship, immigration status, disabilities, or protected veteran status.
    $73k-105k yearly est. Auto-Apply 60d+ ago
  • Engineering Project Manager

    Scientific Protein Laboratories 4.2company rating

    Waunakee, WI jobs

    Join our team at Scientific Protein Laboratories (SPL), a world leader in biosourced pharmaceuticals, located just outside of Madison, Wisconsin in Waunakee! SPL is an innovative biopharmaceutical leader with unique products and services supporting the pharmaceutical industry globally. For over 40 years, SPL specializes in the development and cGMP compliant manufacturing of Active Pharmaceutical Ingredients (APIs). SPL has an exciting opportunity to join the team as an Engineering Project Manager Incumbent is responsible for planning, administering, and completing assigned projects which may cross several functional areas. The Engineering Project Manager provides engineering guidance, planning, budgets, managerial reports and technical support for active pharmaceutical ingredient processes, and facility projects. This requires experience in design, construction and management of facility expansions and equipment installations. Leads process and equipment changes to achieve production requirements. Analyze production and utility equipment operations, routine maintenance, and energy requirements of pharmaceutical manufacturing systems to optimize economical operation and meet regulatory requirements. Responsibilities include: Provide engineering guidance and project management to complete assigned engineering projects starting with development of project scope through detail designing, budgeting, funding approval, project scheduling, construction completion and/or equipment installation, start-up commissioning, validation, and documentation. Develop design (process, facility, etc.) parameters for the manufacture of active pharmaceutical ingredients, including equipment and facility specifications. Develop funding justification, seek approval, and then accomplish and control projects within funding approval. Provide scope, hire, manage, supervise, review, and seek authorization of contracts for consulting engineering firms and construction contractors to accomplish the actual changes of processes, equipment, and facilities. Supervise installation, start-up, commissioning, and support validation of processing equipment. Document performance of processing systems to achieve validation and compliance with QA and other regulatory requirements and agencies. Design tests and methods to analyze process and utility conditions to optimize operational efficiencies and/or to meet defined process and product specifications. Effectively manage multiple projects at the same time. Lead cross-functional, data-driven troubleshooting of process and utility upsets using 5-Why, Ishikawa, FMEA, and A3/DMAIC; convert findings into durable CAPAs. Optimize process and clean utilities (WFI/RO, clean steam, compressed air/N₂, cleanroom HVAC pressure cascades) to improve yield, uptime, and energy/water intensity. Design and execute DOEs to tighten control of CPPs/CQAs; translate results into setpoints, tolerances, and alarm limits with documented rationale. Establish and maintain SPC/CPV trending and simple dashboards; act on signals (trend shifts, OOS/OOT) with timely investigations. Institutionalize gains through cGMP change control: update URS/specs, redlines/as-builts, SOPs, and training; ensure re-qualification (IQ/OQ/PQ) where required. Strengthen asset reliability via criticality analysis and CMMS-backed PM/PdM (e.g., vibration, thermography), and close out punch lists with pristine documentation. Job Requirements and Qualifications: Position will be filled up to the mid-level and determined at discretion of the hiring manager. Education: Bachelor's degree in engineering required (mechanical or chemical preferred). Working toward WI Professional Engineer License with FE Test Experience: 5 plus years of experience required; 10 plus years of experience preferred WHY JOIN SPL? Our employees are our success! We recruit motivated people, recognize their contributions, and support their development to reach their full potential. Perks include: competitive compensation; excellent benefits package - including Medical, Dental and Vision on Day 1; Life and AD&D Insurance, and Short and Long-term Disability; Health and Flexible Saving Account options; Employee Assistance Program, generous vacation; paid Holidays; 401k; advancement opportunities; team-oriented environment; community involvement; company events and more! SPL is an equal opportunity employer. All qualified applicants will receive consideration for employment without regard to age, color, creed, disability, gender identity, national origin, protected veteran status, race, religion, sex, sexual orientation, and any other status protected by applicable local, state or federal law. Qualifications JOB SUMMARY Join our team at Scientific Protein Laboratories (SPL), a world leader in biosourced pharmaceuticals, located just outside of Madison, Wisconsin in Waunakee! SPL is an innovative biopharmaceutical leader with unique products and services supporting the pharmaceutical industry globally. For over 40 years, SPL specializes in the development and cGMP compliant manufacturing of Active Pharmaceutical Ingredients (APIs). SPL has an exciting opportunity to join the team as an Engineering Project Manager Incumbent is responsible for planning, administering, and completing assigned projects which may cross several functional areas. The Engineering Project Manager provides engineering guidance, planning, budgets, managerial reports and technical support for active pharmaceutical ingredient processes, and facility projects. This requires experience in design, construction and management of facility expansions and equipment installations. Leads process and equipment changes to achieve production requirements. Analyze production and utility equipment operations, routine maintenance, and energy requirements of pharmaceutical manufacturing systems to optimize economical operation and meet regulatory requirements. Responsibilities include: Provide engineering guidance and project management to complete assigned engineering projects starting with development of project scope through detail designing, budgeting, funding approval, project scheduling, construction completion and/or equipment installation, start-up commissioning, validation, and documentation. Develop design (process, facility, etc.) parameters for the manufacture of active pharmaceutical ingredients, including equipment and facility specifications. Develop funding justification, seek approval, and then accomplish and control projects within funding approval. Provide scope, hire, manage, supervise, review, and seek authorization of contracts for consulting engineering firms and construction contractors to accomplish the actual changes of processes, equipment, and facilities. Supervise installation, start-up, commissioning, and support validation of processing equipment. Document performance of processing systems to achieve validation and compliance with QA and other regulatory requirements and agencies. Design tests and methods to analyze process and utility conditions to optimize operational efficiencies and/or to meet defined process and product specifications. Effectively manage multiple projects at the same time. Lead cross-functional, data-driven troubleshooting of process and utility upsets using 5-Why, Ishikawa, FMEA, and A3/DMAIC; convert findings into durable CAPAs. Optimize process and clean utilities (WFI/RO, clean steam, compressed air/N₂, cleanroom HVAC pressure cascades) to improve yield, uptime, and energy/water intensity. Design and execute DOEs to tighten control of CPPs/CQAs; translate results into setpoints, tolerances, and alarm limits with documented rationale. Establish and maintain SPC/CPV trending and simple dashboards; act on signals (trend shifts, OOS/OOT) with timely investigations. Institutionalize gains through cGMP change control: update URS/specs, redlines/as-builts, SOPs, and training; ensure re-qualification (IQ/OQ/PQ) where required. Strengthen asset reliability via criticality analysis and CMMS-backed PM/PdM (e.g., vibration, thermography), and close out punch lists with pristine documentation. Job Requirements and Qualifications: Position will be filled up to the mid-level and determined at discretion of the hiring manager. Education: Bachelor's degree in engineering required (mechanical or chemical preferred). Working toward WI Professional Engineer License with FE Test Experience: 5 plus years of experience required; 10 plus years of experience preferred WHY JOIN SPL? Our employees are our success! We recruit motivated people, recognize their contributions, and support their development to reach their full potential. Perks include: competitive compensation; excellent benefits package - including Medical, Dental and Vision on Day 1; Life and AD&D Insurance, and Short and Long-term Disability; Health and Flexible Saving Account options; Employee Assistance Program, generous vacation; paid Holidays; 401k; advancement opportunities; team-oriented environment; community involvement; company events and more! SPL is an equal opportunity employer. All qualified applicants will receive consideration for employment without regard to age, color, creed, disability, gender identity, national origin, protected veteran status, race, religion, sex, sexual orientation, and any other status protected by applicable local, state or federal law.
    $74k-106k yearly est. 21d ago
  • Engineering Project Manager

    Pharmatek Consulting 4.0company rating

    Saint Louis, MO jobs

    Candidate will be responsible for Multiple Automation Engineering Projects : Manage design, installation, and quality testing aspects of automation projects in a GMP facility. Understand and manage the Lifecycle of automation projects Manage the materials planning, budget development, and cost control Manage a detailed project schedule and work plan Contribute to identifying and addressing complex technical issues Interface with vendors, when necessary, to ensure vendors deliver parts, materials, components, equipment, and services on -time, on -budget, and to technical specifications Requirements Good technical understanding of the automation space. Need technical knowledge of IT/automation (i.e. server upgrades, DeltaV, PLC ) and technical knowledge in the automation space is also necessary, but that's just to be effective as a PM. A successful candidate for this position should possess technical knowledge including, but not limited to: data exchange, supervisory control (including SCADA systems and HMI's), historians, programming and configuration (specifically in control logic), distributed control systems (DeltaV) and integration with enterprise systems.
    $66k-97k yearly est. 60d+ ago

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