Spark Enrollment Process Jobs in Usa

14,772 positions found — Page 13

Sterile Processing Technician Full Time Evening
Salary not disclosed
Washington, DC 2 days ago
Responsibilities

About the Role

The Sterile Processing Technician plays a vital role in ensuring the safety and efficiency of surgical services. This position manages the full reprocessing cycle for surgical instrumentation, including disassembly, decontamination, disinfection, inspection, testing, assembly, packaging, high-level disinfection, and sterilization.

Key Responsibilities

  • Operate ultrasonic cleaners, washers, sterilizers, and related equipment.
  • Conduct quality monitoring and documentation.
  • Prepare case carts with instruments and supplies for surgery.
  • Perform quality assurance checks and maintain supply inventory.
  • Mentor and train new technicians, promoting teamwork and excellence.

Main Benefits

  • Challenging and rewarding work environment
  • Growth and Development Opportunities within UHS and its Subsidiaries
  • Competitive Compensation
  • $100 monthly commute subsidy
  • Excellent Medical, Dental, Vision and Prescription Drug Plan
  • 401k plan with company match

About GW Hospital

The George Washington University Hospital is a 395-bed tertiary care, academic medical center located in downtown Washington, DC. Featuring a Level I Trauma Center and a Level III NICU, GW Hospital offers clinical expertise in a variety of areas, including cardiac, cancer, neurosciences, womens health, and advanced surgery, including robotic and minimally invasive surgery. The mission of GW Hospital is to provide the highest quality health care, advanced medical technology and world-class service to its patients in an academic medical center dedicated to education and research. For more information, visit . Physicians are independent practitioners who are not employees or agents of The George Washington University Hospital. The hospital shall not be liable for actions or treatments provided by physicians.


Qualifications
  • High School diploma or equivalent.
  • Minimum two years of sterile processing experience as a certified SPD Tech.
  • CRCST or equivalent certification (CSPDT). Additional certifications preferred.
  • Strong communication, organization, and critical-thinking skills.
  • Familiarity with Microsoft Office and instrument management systems (Censis, OneSource).

About Universal Health Services: One of the nations largest and most respected providers of hospital and healthcare services, Universal Health Services, Inc. (NYSE: UHS) has built an impressive record of achievement and performance. Growing steadily since its inception into an esteemed Fortune 300 corporation, annual revenues were $15.8 billion in 2024. During the year, UHS was again recognized as one of the Worlds Most Admired Companies by Fortune; and listed in Forbes ranking of Americas Largest Public Companies. Headquartered in King of Prussia, PA, UHS has approximately 99,000 employees and continues to grow through its subsidiaries. Operating acute care hospitals, behavioral health facilities, outpatient facilities and ambulatory care access points, an insurance offering, a physician network and various related services located all over the U.S. States, Washington, D.C., Puerto Rico and the United Kingdom. Statement: All UHS subsidiaries are committed to providing an environment of mutual respect where equal employment opportunities are available to all applicants and teammates. UHS subsidiaries are equal opportunity employers and as such, openly support and fully commit to recruitment, selection, placement, promotion and compensation of individuals without regard to race, color, religion, age, sex (including pregnancy, gender identity, and sexual orientation), genetic information, national origin, disability status, protected veteran status or any other characteristic protected by federal, state or local laws. We believe that diversity and inclusion among our teammates is critical to our success.

Avoid and Report Recruitment Scams: At UHS and all our subsidiaries, our Human Resources departments and recruiters are here to help prospective candidates by matching skill set and experience with the best possible career path at UHS and our subsidiaries. During the recruitment process, no recruiter or employee will request financial or personal information (e.g., Social Security Number, credit card or bank information, etc.) from you via email. Our recruiters will not email you from a public webmail client like Hotmail, Gmail, Yahoo Mail, etc. If you suspect a fraudulent job posting or job-related email mentioning UHS or its subsidiaries, we encourage you to report such concerns to appropriate law enforcement. We encourage you to refer to legitimate UHS and UHS subsidiary career websites to verify job opportunities and not rely on unsolicited calls from recruiters.

permanent
Director of Sterile Processing / Sterile Processing Director
✦ New
Salary not disclosed
Hendersonville, NC 1 day ago
Director of Sterile Processing - Day Shift - North Carolina Education:
Bachelor s degree in Business or Nursing OR completion of a Two-Year Surgical Technology Course
Certification:
CSPDT or CRCST certification (IAHCSMM required)
Experience:
Minimum of 5 years in Sterile Processing, with progressive leadership experience
Strong leadership, communication, and technical skills
Knowledge of OR instrumentation, aseptic technique, and infection control
Acute Care experience required
Experience leading large teams in large healthcare facilities
Department Details:
7 Team Leads, 80 FTEs
Uses SPM Workflow system
Supports: Endo, OR, CVOR, L&D, Inpatient & Outpatient Ambulatory Clinics

APPLY NOW or contact Megan directly at (accepts texts) / . You can also schedule a quick call with Megan using this .
Not Specified
Central Sterile Processing Technician - FT Days
✦ New
Salary not disclosed
Rhinebeck, NY 1 day ago
Description
Position at Northern Dutchess Hospital
At Nuvance Health, we enjoy the benefits of a two-state system as we cultivate an inclusive culture where everyone feels welcomed, respected and supported. Together, we are a team of 15,000+ strong hearts and open minds. If you share our values of connected, personal, agile and imaginative, we invite you to discover what's possible for you and your career.
Northern Dutchess Hospital is an 84-bed hospital located in picturesque Rhinebeck, New York. We are leaders in the Hudson Valley for maternity and orthopedic excellence and provide award-winning care in a wide range of specialties, from cancer and heart disease prevention to bariatric surgery and healthy aging services.
Our accolades include the following:
  • The Leapfrog Group - Grade A for quality and patient safety
  • U.S. News & World Report - High performance in knee replacement
  • Surgical Review Corporation (SRC) - Robotic Center of Excellence
  • Center for Medicare and Medicaid Services (CMS) - 5 Star Rating

At Northern Dutchess Hospital, we pride ourselves on a culture of collaboration and teamwork, where every voice is valued and contributes to our shared success. When you step through our doors, you will feel a warm and welcoming atmosphere that makes our hospital a truly special place to work. Our staff is friendly, dedicated and deeply committed to the well-being of our patients and each other's success.
Summary of Job Purpose:
  • Provides decontamination, packaging, sterilization and distribution of equipment and instrumentation to all patient care departments of the hospital. Population served based on scope of services in the department.

Job Qualifications:
  • Education: HS Diploma or equivalent
    License: CRCST required
  • Experience: One year experience as Central Sterile Supply Aide desirable; experience in a health care setting.
  • Training: Understanding of aseptic technique and infection control. Thorough knowledge of the names and functions of surgical instruments.

Responsibilities:
  • Breaking down of instrumentation, cleaning and processing patient care items for use throughout the hospital.
  • Conducting vacuum tests, biologicals and keeping records for all sterilizers.
  • Making rounds to O.B., Med/Surg, ICU and E.R. to collect items used for patient care, process them and return them to their respective units.
  • Taking inventory, ordering and storing supplies in work area to maintain par levels.
  • Picking up clean linen and scrub suits from laundry department, sorting, folding, delinting, stamping and delivering to O.R. and O.B..
  • Demonstrating knowledge of safe operation of sterilizers, according to hospital policy and procedure.
  • Maintaining a clean, well organized environment in the CSD.
  • Communication - Demonstrates a cooperative spirit with co-workers in the communication of essential information.
  • Other duties - Assumes other related duties as assigned or identified.
  • Displays analytical and basic problem solving skills. Communicates problems to manager as appropriate.
  • Follows all time and attendance policies.
  • Attends educational programs provided by the Hospital or those which are outside the Hospital that are related to job responsibilities.

Working Conditions:
  • Potential risk of blood borne pathogens: Exposure to heat, lint and humidity.
  • Essential Physical Demands Of The Job: Moderate to heavy lifting; pushing/pulling heavy carts; frequent, prolonged standing/walking.
  • Essential Mental Demands Of The Job: Ability to organize and prioritize tasks.
  • Manual Dexterity Required: Full range of motion, fine motor skills
  • Company: Northern Dutchess Hospital
  • Org Unit: 1902
  • Department: Sterile Processing
  • Exempt: No
  • Salary Range: $20.23 - $37.56 Hourly

With strong hearts and open minds, we're pushing past boundaries and challenging the expected, all in the name of possibility. We are neighbors caring for neighbors, working together as partners in health to improve the lives of the people we serve. If you share our passion for the health of our communities, advance your career with Nuvance Health!
Not Specified
Sterile Processing Technician - Mount Carmel Grove City
✦ New
Salary not disclosed
Grove city, OH 1 day ago
Employment Type:Full timeShift:Evening ShiftDescription:

Shift Details:

Option 1: Monday - Friday from 1:00 pm - 9:30 pm OR 2:00 pm - 10:30 pm

Option 2: Tuesday- Friday from 3:00 pm - 1:30 am OR 1:00 pm - 11:30 pm

Position Purpose:

In accordance with the Mission and Guiding Behaviors; the Instrument Technician Non-Certified is responsible for the reprocessing of reusable general hospital and surgical equipment and supplies to include advanced surgical instruments and laparoscopic instruments, Orthopedic specialty, and case carts.

What you will do:

  • Exhibits each of the Mount Carmel Service Excellence Behavior Standards holding self and others accountable and role modeling excellence for all to see. For example: demonstrates friendliness and courtesy, effective communication creates a professional environment and provides first class service.

  • Meets population specific and all other competencies according to department requirements.

  • Promotes a Culture of Safety by adhering to policy, procedures and plans that are in place to prevent workplace injury, violence or adverse outcome to associates and patients.

  • Relationship-based Care: Creates a caring and healing environment that keeps the patient and family at the center of care throughout their experience at Mount Carmel following the principles of our interdisciplinary care delivery system.

  • (For patient care providers) Provides nursing care, ensures an environment of patient safety, promotes evidence-based practice and quality initiatives, and exhibits professionalism in nursing practice within the model of the ANCC Magnet Recognition Program.

  • Performs decontamination process procedures.

  • Performs assembly process and procedures.

  • Performs sterilization process and procedures.

  • Performs sterile storage and inventory control process procedures.

  • Performs case cart preparation process utilizing appropriate pick sheets/preference cards.

Other Responsibilities:

  • Performs above duties independently in multiple specialties.

  • Works proficiently without direct supervision.

  • Informs immediate supervisor or in-charge tech of inventory shortages and missing instrumentation.

  • Maintains a safe work environment.

  • Prioritizes workload.

  • Identifies various surgical instrumentation accurately.

  • Responsible for using proper packaging and processing techniques.

  • Communicates back-order information and facilities appropriate substitutions.

  • Responsible for Proper Quality Assurance Documentation.

  • Participates in and fosters a performance improvement approach that includes both intra-departmental and interdepartmental activities.

  • Responsible for compliance with Organizational Integrity through raising questions and

  • promptly reporting actual or potential wrongdoing.

  • All other duties as assigned.

Minimum Qualifications:

  • Education: High School graduate or equivalent

  • License / Certification: N/A

  • Experience: Preferred, but not required

  • Effective Communication Skills

  • Effective mathematical skills.

  • Ability to work with minimal supervision and willingness to participate in a team environment.

  • Basic knowledge of medical terminology.

Position Highlights and Benefits:

  • Mount Carmel Health System recognized by Forbes in 2025 as one of Americas Best State Employers.

  • Competitive compensation and benefits packages including medical, dental, and vision with coverage starting on day one.

  • Retirement savings account with employer match starting on day one.

  • Generous paid time off programs.

  • Employee recognition programs.

  • Tuition/professional development reimbursement starting on day one.

  • RN to BSN tuition 100% paid at Mount Carmels College of Nursing.

  • Relocation assistance (geographic and position restrictions apply).

  • Employee Referral Rewards program.

  • Mount Carmel offers DailyPay - if youre hired as an eligible colleague, youll be able to see how much youve made every day and transfer your money any time before payday.?You deserve to get paid every day!

  • Opportunity to join Diversity, Equity, and Inclusion Colleague Resource Groups.

Ministry/Facility Information:

Mount Carmel, a member of Trinity Health, has been a transforming healing presence in Central Ohio for over 135 years. Mount Carmel serves over 1.3 million patients each year at our five hospitals, free-standing emergency centers, outpatient facilities, surgery centers, urgent care centers, primary care and specialty care physician offices, community outreach sites and homes across the region. Mount Carmel College of Nursing offers one of Ohio's largest undergraduate, graduate, and doctor of nursing programs. If youre seeking a rewarding career where your purpose, passion, and desire to make a difference come alive, we invite you to consider joining our team. Here, care is provided by all of us For All of You!

Legal Info (auto-populated in posting):

We are an Equal Opportunity Employer and do not discriminate against any employee or applicant for employment because of race, color, sex, age, national origin, religion, sexual orientation, gender identity, status as a veteran, and basis of disability or any other federal, state or local protected class.

Our Commitment

Rooted in our Mission and Core Values, we honor the dignity of every person and recognize the unique perspectives, experiences, and talents each colleague brings. By finding common ground and embracing our differences, we grow stronger together and deliver more compassionate, person-centered care. We are an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability, veteran status, or any other status protected by federal, state, or local law.

Not Specified
Financial Paralegal (Process Coordinator)
Salary not disclosed
Richmond, VA 4 days ago

The Financial Reporting Process Coordinator serves as a key member of the fund administration team, supporting the end-to-end workflow of financial statements, regulatory filings, and related reporting materials for registered investment companies and advisors. The Coordinator oversees the routing and distribution of documents, maintains accurate status tracking, reviews and consolidates comments from legal, compliance, audit, and advisor groups, and ensures that all deliverables progress through the review cycle efficiently and in accordance with internal and regulatory expectations.


Key Responsibilities

  • Maintain and update production schedules and status trackers for financial statements, tailored shareholder reports, and regulatory filings.
  • Manage document flow between auditors, legal counsel, compliance teams, fund advisors, and internal stakeholders.
  • Collect, review, and route comments from all parties; ensure feedback is logged, addressed, and escalated when needed.
  • Understand when an issue is routine vs. when it requires escalation to senior staff.
  • Maintain clean version control and document history across Word, Excel, and PDFs
  • Ensure documents are stored, labeled, and distributed properly and securely.
  • Support the fund administration team in meeting deadlines and managing review cycles.
  • Help reinforce consistent processes and document-control standards.



Preferred Skills & Experience

  • Strong proficiency with Microsoft Word, Excel, and PDF markup tools.
  • Workiva experience is a major plus.
  • Excellent verbal and written communication skills.
  • Ability to manage multiple deadlines and shifting priorities without sacrificing accuracy.
  • Strong attention to detail and comfort working with regulated documents.
  • Ability to identify issues, ask informed questions, and escalate when appropriate.
  • Self-directed work style with ownership of recurring processes.
  • Flexibility during peak reporting cycles.
Not Specified
Process Engineer II - 1st Shift
Salary not disclosed
Maitland, Florida 3 days ago

Date Posted:

2

Country:

United States of America

Location:

US-AZ-TUCSON-801 ~ 1151 E Hermans Rd ~ BLDG 801 (External Site)

Position Role Type:

Onsite

U.S. Citizen, U.S. Person, or Immigration Status Requirements:

Active and transferable U.S. government issued security clearance is required prior to start date. U.S. citizenship is required, as only U.S. citizens are eligible for a security clearance

Security Clearance Type:

DoD Clearance: Secret

Security Clearance Status:

Active and existing security clearance required on day 1

At Raytheon, the foundation of everything we do is rooted in our values and a higher calling – to help our nation and allies defend freedoms and deter aggression. We bring the strength of more than 100 years of experience and renowned engineering expertise to meet the needs of today's mission and stay ahead of tomorrow's threat. Our team solves tough, meaningful problems that create a safer, more secure world.

What You Will Do

If you're self-motivated and thrive working with multi-disciplined teams who are committed to innovation and pushing the boundaries of technology, then this might be the perfect job.

As a Raytheon Process Engineer, you'll work to improve processes to maintain efficiency, reduce costs, improve sustainability and safety and maximize profitability.

You're the in-factory materials and process specialist, and your responsibilities will include verifying that Technical Data Package (TDP) shelf-life materials are correctly called out in Manufacturing Data Packages (MDPs) and writing material processing procedures. In addition, you'll collaborate on integrating process equipment within the factory and you'll document the equipment's functionality.

As a Process Engineer II, your responsibilities will also include:

  • Quickly addressing production issues related to materials and processes, ensuring root causes of issues are understood and solutions are robust and cost effective
  • Assisting with on-the-job training for materials and processes
  • Actively participating in daily production meetings
  • Collaborating with Factory personnel
  • Notifying the Materials Management Team of any potential materials obsolescence or supply chain interruptions
  • Assisting the Process Engineer working with Materials & Process Engineering (M&PE) to quickly address problem buys and obsolete materials. This includes identifying end users, determining material requirements, finding alternatives (drive testing as needed), ensuring new materials will work in existing processes and using the opportunity to drive to common materials
  • Helping to improve processes utilizing Lean manufacturing techniques to reduce variability, eliminate constraints and provide ongoing process sustainment
  • Helping to drive use of common materials based on allowable requirements on the drawing, utilizing process engineering tools
  • Assisting in creating or editing Manufacturing Procedures
  • Supporting process troubleshooting efforts to quickly and efficiently resolve manufacturing process issues and coordinating with Materials & Process Engineering (M&PE) Labs to do root Cause Corrective Action as required
  • This position involves direct support of manufacturing activities and requires spending time in and around factory areas

This is a 1st Shift Job.

This job is posted as ONSITE, and is based at Raytheon's Tucson, AZ facility.

Qualifications You Must Have

  • Typically Requires a Bachelor's Degree in Science, Technology, Engineering or Math (STEM) and minimum 2 years of relevant experience.
  • Experience with manufacturing processes
  • Experience with project execution

Qualifications We Prefer

  • Bachelor's or Master's Degree in Chemical Engineering, Material Science, Manufacturing Engineering or Mechanical Engineering preferred
  • Experience with materials and material testing
  • Experience with lean manufacturing
  • Experience with technical writing
  • Skilled problem solver and team player
  • Excellent interpersonal and communication skills
  • A hands-on and self-motivated learner with the ability to work independently and in a group environment

What We Offer

Our values drive our actions, behaviors, and performance with a vision for a safer, more connected world. At RTX we value: Safety, Trust, Respect, Accountability, Collaboration, and Innovation.

Learn More & Apply Now!

  • Please consider the following role type definition as you apply for this role. Onsite: Employees who are working in Onsite roles will work primarily onsite. This includes all production and maintenance employees, as they are essential to the development of our products.
  • This position requires a security clearance. DCSA Consolidated Adjudication Services (DCSA CAS), an agency of the Department of Defense, handles and adjudicates the security clearance process. More information about Security Clearances can be found on the US Department of State government website here: Security Clearance FAQs - United States Department of State
  • This position is an onsite role – Tucson, AZ: ,-az-location
  • We Are RTX

We Are RTX - YouTube

As part of our commitment to maintaining a secure hiring process, candidates may be asked to attend select steps of the interview process in-person at one of our office locations, regardless of whether the role is designated as on-site, hybrid or remote.

The salary range for this role is 68,900 USD - 131,100 USD. The salary range provided is a good faith estimate representative of all experience levels. RTX considers several factors when extending an offer, including but not limited to, the role, function and associated responsibilities, a candidate's work experience, location, education/training, and key skills. Hired applicants may be eligible for benefits, including but not limited to, medical, dental, vision, life insurance, short-term disability, long-term disability, 401(k) match, flexible spending accounts, flexible work schedules, employee assistance program, Employee Scholar Program, parental leave, paid time off, and holidays. Specific benefits are dependent upon the specific business unit as well as whether or not the position is covered by a collective-bargaining agreement. Hired applicants may be eligible for annual short-term and/or long-term incentive compensation programs depending on the level of the position and whether or not it is covered by a collective-bargaining agreement. Payments under these annual programs are not guaranteed and are dependent upon a variety of factors including, but not limited to, individual performance, business unit performance, and/or the company's performance. This role is a U.S.-based role. If the successful candidate resides in a U.S. territory, the appropriate pay structure and benefits will apply. RTX anticipates the application window closing approximately 40 days from the date the notice was posted. However, factors such as candidate flow and business necessity may require RTX to shorten or extend the application window.

RTX is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, age, disability or veteran status, or any other applicable state or federal protected class. RTX provides affirmative action in employment for qualified Individuals with a Disability and Protected Veterans in compliance with Section 503 of the Rehabilitation Act and the Vietnam Era Veterans' Readjustment Assistance Act.

Privacy Policy and Terms:

Click on this link to read the Policy and Terms

Not Specified
Process Technician
Salary not disclosed
Tualatin, OR 4 days ago

Process Technician – ALD Oxide | Night Shift | R&D Lab Environment

We’re hiring a Process Technician to support advanced semiconductor R&D operations in a cleanroom setting. This is a long-term contract opportunity ideal for candidates with strong attention to detail, technical aptitude, and a passion for hands-on work in a high-tech environment.


Location

  • Tualatin OR (onsite role)


Schedule

  • Shift: Front-end nights (Sunday–Tuesday + alternating Saturdays)
  • Hours: 4:30 PM – 4:30 AM
  • Training: 6 weeks on Thursday–Saturday + alternating Wednesdays, 4:30 AM – 5:00 PM


Responsibilities

  • Operate wafer processing and metrology tools in a Class 10 cleanroom
  • Follow documented procedures and engineering instructions
  • Maintain lab cleanliness and safety standards
  • Document results and communicate clearly via email and internal systems
  • Perform basic troubleshooting and send daily shift passdowns
  • Walk 3–8 miles/day and lift/carry ~20 lbs regularly


Qualifications

  • HS Diploma or equivalent (Associate’s degree preferred)
  • Strong multitasking and attention to detail
  • Proficiency in Excel, Outlook, and general computer skills
  • Dependable, self-motivated, and able to work independently
  • Proven job stability and ability to adapt to changing priorities


Interview Process

  • Initial video interview
  • Onsite panel interview (if selected)
  • Three professional references required (from Engineering or Management level)


If you're interested in joining a cutting-edge team and contributing to innovative R&D work, apply now or message me directly for more details!

#ProcessTechnician #SemiconductorJobs #Cleanroom #RDLab #NightShift #HiringNow #TechJobs #ManufacturingCareers

Not Specified
Director Process Development and Manufacturing, CMC
Salary not disclosed
Durham, NC 4 days ago

Job Title: Director Process Development and Manufacturing, CMC

Department: CMC

Reports to: Chief Technical Officer


About the Company:  

Opus Genetics is committed to building an innovative, efficient and sustainable science based and commercial ophthalmic biopharmaceutical company leading the development of transformative gene therapies for the treatment of inherited retinal diseases (IRDs) and therapies to treat patients with other retinal and refractive disorders.


Job Summary: 

The Director of Process Development and Manufacturing will be the technical lead for development and manufacturing of assigned assets within the Opus gene therapy programs focusing on technical transfer and process development and execution supporting product development and manufacturing to achieve company goals and strategies. This includes working collaboratively with external partners (i.e. CDMOs, contract labs, suppliers) to develop technical studies, analyze complex data, make data driven decisions, and author, review, and approve technical and regulatory documents. The ideal candidate will have a deep technical understanding of AAV gene therapy upstream and downstream development and process optimization.  This role will directly interact with the CDMO/contract partners and be responsible for building and maintaining excellent working relationships. Knowledge of manufacturing platforms, consistent with AAV technology, at scales ranging from process development through GMP and PPQ activities. The candidate will be hands-on and expected to provide content to all these areas. 

Duties/Responsibilities: 

·      Work with Opus CDMO/contract manufacturing and laboratory partners to develop a phase appropriate robust manufacturing program to support the process development and engineering of pre commercial and commercial cGMP material to support pre-clinical studies, clinical trials, and commercial supply. 

·      Support, author, and review/approve manufacturing plans and documentation including technical transfer, batch records and documentation, product specifications, stability programs, bridging and comparability studies, and other reports utilizing phase appropriate QbD best practices.

·      Support, author, and review/approve manufacturing documentation including testing records, certificates of testing/analysis, campaign summary reports, investigations, etc. 

·      Support, author, and review/approve regulatory documentation including pINDs, INDs, agency responses, CMC meeting requests and briefing packages, and BLAs.   

·      Ensure proper reference standard material is in place, tested, and released for each product. Lead technology transfer between sites. 

·      Ensure regulatory requirements are in place to support manufacturing campaigns with respect to Master Cell Banks, Plasmids, Drug Substances, Drug Products, and Diluents, to prevent developmental delays and or interruptions to clinical programs or regulatory filings.

·      Perform the role of person in plant as needed at the Opus CDMO/contract manufacturing partner’s sites. Act as the CMC expert during audits and interactions with regulatory agencies. 

·      Manage work to project plans for multiple gene therapy programs in the preclinical, pre-IND, IND/clinical, and commercial stages. 

·      Identify and lead the resolution of operational and functional level challenges, work with program and/or function managers to escalate issues to senior management.

·       Hands on resolution to issues/content generation. Design effective and high-quality presentations and progress reports, as requested.

  

Supervisory Responsibilities: 

·      None 

 

Education and Experience: 

·      Master’s degree (minimum) from an accredited institution in a science or health-related field with minimum of 7-10 years of experience in the pharmaceutical or biotechnology industry. Ophthalmology experience is preferred.

·      Additionally, a minimum of 5 years of direct manufacturing experience for biopharmaceuticals. Preference will be given for direct AAV gene therapy experience. Previous CDMO/contract lab experience also preferred.

·      Experience designing and executing technical transfer and scale up campaigns and associated documentation.

·      Experience in writing and reviewing regulatory submissions including pINDs, INDs, Meeting Requests/Briefing Packages, Annual Report/DSUR’s, and BLAs. 

·      Experience with FDA and/or other regulatory agency requirements and interactions.

·      Strong skill set in interacting with multidisciplinary teams for preclinical and clinical development. Clear understanding of the drug development process with experience in multiple phases.

·      Experience with Orphan/Rare Disease programs, and/or Fast Track/Breakthrough Therapy is a plus.

·      Demonstrated leadership skills and ability to influence across all levels of a cross-functional team without direct managerial authority. Experience in risk assessment, negotiation, and problem solving/mitigation.

·      Outstanding interpersonal skills, ability to communicate effectively in both oral and written form, with effective time management skills needed to manage multiple ongoing projects simultaneously.

·      Demonstrated advanced computer software proficiency (Word, Excel, Smartsheet’s, PowerPoint, etc.).  

Physical Requirements:  

·      Ability to travel 20% of time

·      Ability to work in laboratory settings/situations

·      Prolonged periods sitting at a desk and working on a computer. 

·      Must be able to lift up to 15 pounds at times. 

 

 

Location:

This position is currently based in the Durham North Carolina area; Hybrid/ remote options considered.

 

 Salary Range:


$190,000-210,000



The above job description is not intended to be an all-inclusive list of duties and standards of the position. Incumbents will follow any other instructions, and perform any other related duties, as assigned by their supervisor. 

 

Opus Genetics 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. 

 

Not Specified
Senior Manufacturing Process Engineer
Salary not disclosed
San Francisco Bay 4 days ago

Senior Manufacturing Process Engineer

Meet has partnered with an exciting Stealth start-up in the Brain-Computer Interface (BCI) space based in the San Francisco Bay area. The company is developing cutting-edge medical devices and technology for the treatment of unmet neurological disorders. The Head of Operations is seeking an experienced Manufacturing Process Engineer to support NPI of electro-mechanical devices in collaboration with suppliers.


This role will focus on hands-on interaction with suppliers to develop manufacturing processes, tooling, and documentation, from design feasability through commercial release. This role will require real-time engagement and technical support of suppliers, and this individual will be expected to travel often to domestic supplier sites and occasionally to international suppliers.


Primary Responsibilities:

  • Serve as the primary technical liaison to external manufacturing partners, ensuring successful delivery of components, assemblies, and finished devices
  • Collaborate with product development teams to ensure designs are manufacturable and compliant with medical device quality system requirements
  • Develop and maintain manufacturing documentation, including work instructions, process flows, and validation protocols
  • Support supplier implementation of specifications, manufacturing processes, and quality requirements
  • Lead and participate in process validation activities including IQ/OQ/PQ, PFMEA, and failure investigations
  • Drive continuous improvement initiatives related to manufacturing efficiency, quality, cost, and scalability
  • Support resolution of non-conformances and corrective actions with suppliers
  • Ensure manufacturing activities comply with applicable regulatory requirements (FDA, ISO 13485, EU MDR, etc.)
  • Provide hands-on technical support to suppliers, including travel as needed (domestic and international)


Role Requirements:

  • B.S. in relevant engineering discipline, or equivalent experience.
  • 10 or more years of medical device manufacturing experience, preferably in senior roles at start-up companies developing and manufacturing electro-mechanical devices.
  • Experience with active implantable systems (Implant, Leads, Externals, etc.).
  • Experience with medical device manufacturing including molding, laser welding, clean room assembly, packaging, labeling, and sterilization.
  • Experience with electronic manufacturing and test including PCB fab, PCA assembly, microelectronics assembly, flip chip, in circuit test (ICT) and functional test.
  • Experience with manufacturing automation.
  • Experience in defining and executing process validation activities.
  • Experience collaborating with internal customers and external partners.
  • Understanding of and experience implementing validating manufacturing processes for medical devices in accordance with FDA and EU Requirements.
  • Experience with Solidworks, Labview / manufacturing process and test automation software.
  • Ability to travel to Domestic and International supplier sites frequently
Not Specified
BIM Design Engineer (Advanced Semiconductor Process Systems)
Salary not disclosed
Phoenix, AZ 4 days ago

This is more than just a modeling job—it is your gateway to becoming a specialist in Advanced Semiconductor Chemical & Gas Delivery Systems. While you contribute your 1-2 years of site experience, we will provide the platform for you to master the complex logic behind high-purity piping, automated delivery, and international safety codes. You will transition from "building models" to "designing critical infrastructure" for the world's leading tech fabs.


General Responsibilities:

  • Architectural & System Modeling: Develop and prepare high-precision 3D architectural and MEP designs using Revit and AutoCAD.
  • Integrated Coordination: Collaborate with engineers and PMs to ensure design accuracy, ensuring all process requirements are met.
  • Design Evolution: Proactively review and update models to reflect real-time design changes and field adjustments.
  • Conflict Resolution: Perform Clash Detection and lead the reporting/solving of spatial discrepancies to ensure a seamless build.
  • Team Leadership: Participate in technical meetings and provide progress updates to stakeholders.

Specialized Knowledge & Growth

  • P&ID Translation: Read and interpret P&IDs/PFDs (Piping and Instrumentation Diagrams) to align 3D models with functional process logic.
  • Subcontractor Management: Act as the technical bridge, communicating 3D model requirements to subcontractors for onsite coordination.
  • Advanced System Learning: Gain deep-dive knowledge in Chemical Delivery Systems (CDS) and Gas Delivery Systems (BDS) specifically for advanced semiconductor nodes.


Qualification:

  • Minimum Associate Degree in a related engineering or architectural field.


Must Have:

  • Software Mastery: Proficiency in BIM software (Revit) and AutoCAD.
  • Industry Experience: 1–2 years of experience in design-related work, preferably within the semiconductor or high-tech


Nice to Have:

  • Process Piping: Experience with specialized materials like CPVC/PFA, SUS/PFA, and SUS/SUS piping design.
  • Electrical & Control: Knowledge of Power/Control system design, including Tray, Conduit, and RSG layouts.
  • Standards & Codes: Familiarity with NEC or ASME codes is a significant plus.
  • Project Context: Previous involvement in Gas/Chemical-related projects.


What You Will Learn & Achieve

  • Semiconductor Expertise: Master the design logic of supply systems that power the world's most advanced chip manufacturing.
  • Professional Elevation: Move beyond 3D modeling into Digital Engineering, learning how to manage complex data within a BIM environment.
  • Cross-Domain Skills: Gain exposure to mechanical, chemical, and electrical integration, making you a highly versatile asset in the global semiconductor talent market.
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