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Manufacturing Process Engineer - Warehouse

Full time/Direct Hire

Secaucus, NJ - Onsite

About The Role

The Manufacturing Process Engineer is responsible for leading the measurement and analysis of warehouse inventory processes, developing standard operating procedures, and implementing continuous improvement projects. The Manufacturing Engineer's scope of responsibility covers the end-to-end warehouse process (material preparation, receiving, storage, inventory, and shipment preparation). This position is set up to highlight and facilitate the skills needed to develop an individual.

What You Will Do

• Process Development / Support: Design, measure, and support manufacturing process changes; develop standard operating procedures to improve operator efficiency and process consistency.
• Continuous Improvement: Collect and analyze key performance metrics such as cycle time, storage efficiency and yield to drive process and quality improvements.
• Participate in Kaizen events to measure, document, and continuously improve warehouse processes.
• Layout Optimization: Analyze and plan workflow, equipment placement and space requirements to improve warehouse process efficiency.

What You Bring

• Bachelor's degree in engineering or related field, or advanced degree and equivalent experience.
• 3+ years of experience in a manufacturing/warehouse environment.
• Develop detailed layouts for equipment, processes, and workflow.
• Demonstrate proficiency in applying Lean or Six Sigma principles in a variety of situations.
• Strong analytical skills, including the ability to mine data to draw meaningful conclusions.
• Be able to be collaborative, flex and adapt in a warehouse environment.
• Ability to lead a cross-functional team and work with contractors/vendors to drive projects.
• Ability to simplify issues/direction and communicate verbally and in writing to all levels of employees.
• Ability to effectively facilitate projects in a technical, multi-organizational environment

Maxonic maintains a close and long-term relationship with our direct client. In support of their needs, we are looking for a Component Engineer 4.

Job Description:

Job Title: Component Engineer 4

Job Type: Contract

Job Location: Sunnyvale, CA

Work Schedule: On-site

Pay Rate: $94 Based on experience.

DESCRIPTION:

Primary Function of the Position:

• Responsible for ensuring suppliers meet ISI requirements for quality, service, delivery, and cost. Drive suppliers to continuously improve business and manufacturing processes specifically related to wire harness and cable assembly.
• Evaluate and select suppliers within copper cables/harness industry. Guide Engineering in choosing suppliers for new products and providing DFM input to new designs. Supports both NPI and on-going production, monitors and works with suppliers to improve supplier performance. Executes detailed projects with suppliers to implement changes and improvements affecting quality, cost, capacity, risk, and sub-supplier management.

Essential Job Duties:

• Work with NPD to procure custom cables ensuring DFM to achieve quality and cost targets
• Support NPD with proto builds and track material readiness at Supplier Drive supplier root cause analysis for cable harness failures
• Mitigate risks and ensure supply continuity by evaluating capacity, lead times and quality issues
• Develop and maintain harness standards, specifications, and design guidelines.
• Work with Strategic Sourcing to evaluate new suppliers and new supplier manufacturing sites
• Complete project/ part qualification deliverables including Supplier pFMEA, Process Validations (IQ/OQ/PQ), Inspection Reports, Gage R&R, and Process Capability AnalysisWork with suppliers to execute cost reductions, capacity improvements, and risk mitigation.
• Select the right process and supplier for the part, considering long-term fit and total cost of ownership.
• Manage supplier changes including manufacturing process changes, production optimization, facility changes, new equipment qualification, and new line validations.
• Drive changes to ISI requirements as necessary by initiating and managing changes to specifications and drawings through the engineering change order process.
• Own and drive to closure supplier variances from symptom through root cause analysis to corrective action, including careful CAPA documentation.
• Effectively prioritize and advance multiple concurrent projects and tasks Clearly communicate project status to key stakeholders Build, own, and relentlessly pursue a vision for developing suppliers.
• Understand proper level of documentation detail for tracking of actions and justification of decisions.
• Generate key metrics for the team and suppliers and continually drive for timely achievement of those metrics.
• Drive suppliers to continually improve their business and manufacturing process performance to meet requirements for supplier excellence using a collection of best practices in project management, Six Sigma, Lean, SPC and negotiation. Lead these efforts without managerial guidance at several suppliers simultaneously.
• Implement corrective and preventive actions for supplier process by driving supplier’s investigations and root cause analysis.
• Provide effective and timely supply base information and recommendation to management by creating and delivering data-driven supply base information to any level of management at ISI with little or no guidance.
• Prepare and deliver supplier communications as required by independently working with suppliers on scorecard creation.
• Work with suppliers and ISI engineering for the new product introduction to: Create product supplier landscapes to determine launch readiness and report to management.
• Develop supplier ramp readiness plans by judging business risk based on forecast, supplier capacity, quality performance, and process capability.
• DFM by engaging suppliers early in development cycle to feedback manufacturability improvements in the designs prior to production.
• Influence and guide Engineering in choosing suppliers by determining selection criteria for preferred suppliers and leading the team effort to evaluate preferred suppliers.
• Review, analyze and close customer complaints, manufacturing variance requests, and first article inspections by judging risk analyses and justifications.

Required Skills and Experience

• Minimum 7 years related experience with an BS Engineering degree or 5 years’ experience with MS in Engineering.
• Excellent written and verbal communication skills including presentations to executive level management.
• Excellent Interpersonal skills and team building skills.
• A proven history of implementing Lean/6 Sigma/SPC Programs at suppliers.
• Excellent Project Management skills.
• Excellent analytical and problem-solving skills along with good judgment.
• Demonstrable knowledge in evaluating and challenging supplier technical, quality, and business capabilities.
• Demonstrable knowledge of a wide range of manufacturing processes including understanding of key input variables for quality, cost, and capacity (Specialization can be in cable assembly, wire cutting, termination, crimping, Soldering, overmold)

Working Conditions

• Ability to travel to suppliers on an as-needed basis – domestic and international.

Preferred Skills and Experience

• 4-7 years of engineering experience in cable assembly, wire harness production, or electromechanical manufacturing.
• The ideal Candidate possesses broad and deep hands-on cable assembly experience along with wire cutting, stripping, crimping, soldering,

About Maxonic:

Since 2002 Maxonic has been at the forefront of connecting candidate strengths to client challenges. Our award winning, dedicated team of recruiting professionals are specialized by technology, are great listeners, and will seek to find a position that meets the long-term career needs of our candidates. We take pride in the over 10,000 candidates that we have placed, and the repeat business that we earn from our satisfied clients.

Interested in Applying?

Please apply with your most current resume. Feel free to contact Manish Rajput ( /(4 for more details.

Must Haves:

• Experience with process improvement across multiple different business groups
• Identifying inefficiencies
• Investigating and implementing ways to reduce cost
• Maintaining and developing flowsheets for operations
• Create accurate time standards for different phases of a job
• Must be detail oriented
• Experience in manufacturing, logistics, or warehouse
• Experience using Excel for data entry
• Knowledge of data capture
• Comfortable communicating with the shop floor operators and manager level personnel
• 80% of your day will be spent on Shop Floor
• Go getter personality

Nice to Have:

• Engineering Degree
• Knowledge of CAD tools – AutoCad, CATIA, or SolidWorks

Day-To-Day:

A client of Insight Global is looking for a Process Improvement Specialist to sit fully onsite in Middle River, MD. They will be joining a team of 3 and working to improve processes across all business units. In this role, you will focus on improving business processes by identifying inefficiencies and implementing cost-reduction strategies. A typical day may involve analyzing workflows, maintaining, and developing operational flowsheets, and establishing accurate time standards for different job phases. You will regularly use Excel for data entry and data capture, ensuring precision in reporting and analysis. Working in a manufacturing environment, you will collaborate with teams to optimize production efficiency and troubleshoot operational challenges. This position requires a keen eye for detail, problem-solving skills, and a proactive approach to continuous improvement. This is a 6 month contract and pays $25-27/hr.

Compensation:

$25/hr to $27/hr.

Exact compensation may vary based on several factors, including skills, experience, and education.

Benefit packages for this role will start on the 31st day of employment and include medical, dental, and vision insurance, as well as HSA, FSA, and DCFSA account options, and 401k retirement account access with employer matching. Employees in this role are also entitled to paid sick leave and/or other paid time off as provided by applicable law.

Job Description:

SUMMARY: The Process Development Associate I (PDA I) provides scientific and technical support to the Process Development (PD) team. Working under direct supervision and guidance from senior PD staff, this role is responsible for executing defined laboratory tasks and established protocols to support process characterization and optimization activities. The PDA I contributes to the production of dopaminergic precursor cells (DANPCs) from induced pluripotent stem cells (iPSCs) by performing routine cell culture experiments, maintaining laboratory operations, and assisting with data collection and documentation in accordance with established procedures.

DUTIES AND RESPONSIBILITIES:

• Under supervision, perform routine laboratory experiments following established protocols to support defined unit operations and process characterization studies. • Support PD study execution by assisting designated study leads with protocol preparation, daily cell culture maintenance, sample handling, and preparation for downstream testing activities.

• Perform cell culture activities using established aseptic techniques, including media preparation and routine culture maintenance, in accordance with standard operating procedures.

• Collect experimental data and assist with data organization, review, and documentation; contribute to summaries and reports under guidance.

• Maintain accurate and timely laboratory documentation in compliance with departmental and quality requirements.

• Prepare or help verify cell culture media preparation to support ongoing experiments within the PD team.

• Support cross functional activities by coordinating with teams such as Analytical Development, Manufacturing Operations, MSAT, Device, and Research as directed.

• Assist with tracking and maintaining laboratory inventory, including media, reagents, and consumables, and support material forecasting activities as assigned.

EDUCATION AND EXPERIENCE:

• Bachelor’s degree in Bioengineering, Biomedical Engineering, Molecular Biology, Neuroscience, or a related scientific discipline is required.

• Entry level experience in academic research laboratories or a relevant industry setting is preferred.

• Cell Culture & Aseptic Technique: Foundational experience with mammalian cell culture and aseptic laboratory techniques in an academic or industry setting.

• Protocol Adherence: Ability to follow established methods, procedures, and standard operating protocols with attention to detail and accuracy.

• Data Analysis & Tools: Basic proficiency with data analysis tools or commercially available software used for scientific data evaluation.

• Documentation & Organization: Strong organizational skills with the ability to maintain accurate, timely, and compliant laboratory documentation.

• Collaboration & Teamwork: Ability to work effectively in a collaborative, team-oriented environment and support cross-functional activities as directed.

• Communication Skills: Clear written and verbal communication skills, with the ability to receive direction and provide status updates to senior staff.

WORKING CONDITIONS

Office and Lab environment. While performing the duties of this Job, the employee is frequently exposed to some toxic or caustic chemicals. This is an indoor position requiring the ability to perform experiments in the laboratory and use a computer. Some Cleanroom access is required

PHYSICAL DEMANDS While performing the duties of this Job, the employee is Regularly required to stand; walk; sit; use hands to finger, handle, or feel; reach with hands and arms and talk or hear. The employee must occasionally lift and/or move up to 20 pounds. Specific vision abilities required by this job include close vision, distance vision, color vision, peripheral vision, depth perception and ability to adjust focus. These work environmental characteristics are representative of the environment the job holder will encounter. Reasonable accommodation may be made to enable people with disabilities to perform the essential functions of the job.

Kelly® Science & Clinical is seeking a Process Engineering Manager for a direct hire opportunity with one of our clients, a leading small molecule CDMO at their Colorado Springs, CO facility. If you’re passionate about bringing the latest scientific discoveries to life and are ready to take the next step in your career, trust The Experts at Hiring Experts.

Workplace: Onsite in Colorado Springs, CO

Position Title: Process Engineering Manager, Oral Dosage Forms

Position Type: Direct hire

Salary: $125,000-140,000

Are you ready to drive innovation and success in pharmaceutical manufacturing? We are seeking a dynamic Principal Investigator to serve as a technical authority in process development, scale-up, and technology transfer. If you thrive in collaborative, fast-paced environments and are passionate about advancing life-changing therapies, this is your opportunity to make a significant impact.

Responsibilities

Strategic Process Development & Scale-Up

• Spearhead the development and scale-up of robust, scalable manufacturing processes across a wide spectrum of drug products
• Design and lead process characterization and optimization studies, defining critical process parameters and proven acceptable ranges
• Champion Quality by Design (QbD) strategies and advanced statistical methodologies, ensuring seamless progression from laboratory concepts to pilot-scale execution

Technology Transfer Leadership

• Serve as the technical lead for all technology transfer activities, bridging R&D, global manufacturing sites, and client partners
• Develop and implement comprehensive transfer protocols and process equivalence strategies to ensure flawless execution
• Lead high-performing, cross-functional teams through knowledge transfer, process mapping, and documentation best practices

Pilot Plant & cGMP Operations Management

• Oversee cGMP-compliant pilot plant operations, supporting clinical and commercial production, validation, and process improvement
• Drive continuous improvement projects—maximizing efficiency, quality, and yield
• Provide expert troubleshooting and manage deviations, ensuring on-time project delivery

Capital Projects & Facility Optimization

• Lead equipment qualification and validation for cutting-edge process installations
• Direct facility expansion and modification projects to support innovation and new technology implementation
• Optimize facility workflows to enhance operational excellence and scalability

Quality Assurance & Regulatory Compliance

• Ensure strict adherence to cGMP (21 CFR 210/211) and data integrity (21 CFR 11) regulations
• Develop and execute robust process validation strategies in accordance with global regulatory standards
• Lead investigations, implement corrective/preventive actions, and maintain perpetual audit readiness

Project Management & Client Engagement

• Manage multiple, high-profile client technology transfer programs—delivering on time and within budget
• Serve as the primary technical liaison for clients, providing strategic insight and technical guidance
• Develop detailed project plans, risk assessments, and contingency strategies to de-risk tech transfer activities
• Mentor cross-functional teams, fostering a culture of excellence and innovation

Qualifications

Education:

• Bachelor’s degree in Engineering, Pharmaceutical Sciences, or related field; advanced degree (MS/PhD) preferred

Experience:

• 8+ years’ experience (Bachelor’s), 5+ years (MS), or 3+ years (PhD) in pharmaceutical process development, technology transfer, and scale-up within a CDMO or CRO environment
• Demonstrated success managing complex, cross-functional projects in a regulated setting

Technical Mastery

• Deep expertise in pharmaceutical process engineering, manufacturing technologies, process validation, and equipment qualification
• Comprehensive understanding of cGMP, quality systems, and regulatory compliance
• Proven skills in process automation, risk management, and project execution

Leadership & Collaboration

• Recognized leadership in guiding technical teams and cross-functional project groups
• Outstanding client relationship management and communication abilities
• Strategic thinker with a results-driven mentality, adept at navigating complex challenges and inspiring teams

Why Join Us?

• Work alongside industry leaders and innovators
• Participate in high-impact projects accelerating life-saving therapies to market
• Competitive salary, comprehensive benefits, and opportunities for continued professional growth

What happens next:

Once you apply, you’ll proceed to the next steps if your skills and experience look like a good fit. But don’t worry – even if this position doesn’t work out, you’re still in our network. That means our team of expert Science & Clinical recruiters will have access to your profile, making your opportunities limitless.

Central Processing Supervisor, Core Laboratory - Evening Shift

Location: Boston Teaching Hospital

• Evening Shift: 3p – 11:30p ($3/hr evening diff).
• Must be ASCP certified (or equivalent).
• Sign-on bonus eligible.

Responsibilities:

• Responsible for coordinating the daily operation of the front office of the core laboratory.
• Oversees all Pre and Post analytic activity on the evening shift, in close conjunction with the day shift MT Operations Coordinator, reference lab staff, and other individuals who oversee areas that have an overlapping operating relationship with Central Processing.
• Ensures that all activities, processes and policies are carried out in strict compliance with governmental regulations, licensing agency standards, and hospital policies and procedures.
• Responsible for day-to-day general management including staffing, schedules, payroll, performance management, training, education, development of policy and protocol, compliance, and safety.
• FTE's: 25+/-.
• Reports to the Technical Director of Pre/Post Analytics in the Core Laboratory.

Qualifications:

• MT (ASCP) or equivalent.
• Bachelor’s Degree in Medical Technology or physical sciences.
• 4+ years of hospital laboratory experience, including knowledge of &/or experience with pre/post analytics &/or central processing.
• 1+ years of leadership experience.
• Preferred: experience overseeing non-exempt hourly staff.

At BayCare, we are proud to be one of the largest employers in the Tampa Bay area. Our network consists of 16 community-based hospitals, a long-term acute care facility, home health services, outpatient centers and thousands of physicians. With the support of more than 30,000 team members, we promote a forward-thinking philosophy that’s built on a foundation of trust, dignity, respect, responsibility and clinical excellence.

Manager Sterile Processing Position Details:

• Title: Manager Sterile Processing
• Location: Winter Haven Hospital, FL
• Status: Full Time, Exempt:
• Shift Hours: 8:00 AM - 4:30 PM
• Weekend Work: Occasional
• On Call: No

When you become a BayCare leader, we support your personal and professional growth by offering a range of benefits, educational opportunities and a healthy work-life balance:

• Benefits (Health, Dental, Vision)
• Paid time off
• Tuition reimbursement
• 401k match and additional yearly contribution
• Yearly performance appraisals and leadership award
• Community discounts and more
• Relocation assistance if eligible
• AND the Chance to be part of an amazing team and a great place to work!

The Manager Sterile Processing responsibilities include leadership within the health system demonstrating proficiency in all Quality Leadership skills.

• Expertly manages the entire operation surrounding the sterile processing of instruments and other items necessary to conduct patient care throughout the hospital
• Assumes 24-hour responsibility for the Sterile Processing Department
• Acts as liaison between staff, team members, physicians, other customers and administration
• Perform other duties as assigned

Qualifications

• Sterile Processing Experience:
• Minimum of 3 years of Sterile Processing experience OR
• 5 years of related experience in lieu of an associate degree
• Leadership Experience:
• Minimum of 3 years of management experience OR
• 5 years in a coordinator role within a related field

Education & Certifications

• Associate degree required
• CRCST (Certified Registered Central Service Technician) required
• If an associate degree is not held, the CRCST certification is required in its place
• Bachelor’s degree preferred
• CBSPD – CSIS (Certified Surgical Instrument Specialist) preferred

Founded in 1926, Winter Haven Hospital has an outstanding reputation for superior, patient-centered care. Our mission statement is "to improve the health of the people we serve, by providing the highest quality and most effective care and services -- and to return value to the people in our communities." By upholding this standard of excellence in all that we do, we are able to provide patients throughout central Florida with customized, state-of-the-art treatments in a comfortable environment.

Ready to Lead? Join BayCare and make a lasting impact. Apply today and take your career to the next level!

Equal Opportunity Employer Veterans/Disabled

AI Research Scientist | Machine Learning | Deep Learning | Natural Language Processing | LLM | Hybrid | San Jose, CA

Title: AI Research Scientist

Location: San Jose, CA

Responsibilities:

• Design, execute, and analyze machine learning experiments, establishing strong baselines and selecting appropriate evaluation metrics.
• Stay up to date with the latest AI research; identify, adapt, and validate novel techniques for company-specific use cases.
• Define rigorous evaluation protocols, including offline metrics, user studies, and adversarial (red team) testing to ensure statistical soundness.
• Specify data and annotation requirements; develop annotation guidelines and oversee quality control processes.
• Collaborate closely with domain experts, product managers, and engineering teams to refine problem statements and operational constraints.
• Develop reusable research assets such as datasets, modular code components, evaluation suites, and comprehensive documentation.
• Work alongside ML Engineers to optimize training and inference pipelines, ensuring seamless integration into production systems.
• Contribute to academic publications and represent the company in research communities, as needed.

Educational Qualifications:

• Ph.D. in Computer Science, Artificial Intelligence, Machine Learning, or a related field is strongly preferred.
• Candidates with a master’s degree and exceptional research or industry experience will also be considered.

Industry Experience:

• 3–5 years of experience in AI/ML research roles, ideally in applied or product-focused environments.
• Demonstrated success in delivering research-driven solutions that have been deployed in production.
• Experience collaborating in cross-functional teams across research, engineering, and product.
• Publications in top-tier AI/ML conferences (e.g., NeurIPS, ICML, ACL, CVPR) are a plus.

Technical Skills:

• Strong foundational knowledge in machine learning and deep learning algorithms.
• Hands-on experience with PEFT/LoRA, adapters, fine-tuning techniques, and RLHF/RLAIF (e.g., PPO, DPO, GRPO).
• Ability to read, implement, and adapt state-of-the-art research papers to real-world use cases.
• Proficiency in hypothesis-driven experimentation, ablation studies, and statistically sound evaluations.
• Advanced programming skills in Python (preferred), C++, or Java.
• Experience with deep learning frameworks such as PyTorch, Hugging Face, NumPy, etc.
• Strong mathematical foundations in probability, linear algebra, and calculus.
• Domain expertise in one or more areas: natural language processing (NLP), symbolic reasoning, speech processing, etc.
• Ability to translate research insights into roadmaps, technical specifications, and product improvements.

AI Research Scientist | Machine Learning | Deep Learning | Natural Language Processing | LLM | Hybrid | San Jose, CA

Company Description

Variantyx is a technology-driven precision medicine company providing state-of-the-art diagnostic solutions for the rare genetic disorders and reproductive genetics markets, and treatment optimization in oncology. Our proprietary whole genome analysis platform allows us to better understand a person’s genetic makeup, leading to unmatched diagnostic capabilities and improved personalized treatment recommendations.

visit our website: Description

We are seeking an entry-level Specimen Processing Assistant to support our diagnostic laboratory team at our on-site facility in Framingham, MA. This full-time role involves receiving, processing, and organizing biological specimens, ensuring adherence to laboratory protocols and quality standards. Additional responsibilities include maintaining accurate records, utilizing laboratory tools and software, and collaborating with colleagues to streamline workflows and uphold compliance.

Saturday shift coverage needed.

Position Duties & Responsibilities:

• Receive and triage all patient specimens for testing.
• Accession and manage patient information within the LIMS.
• Collaborates with clinical Coordinators to verify missing patient/sample information.
• Biobanking: sorts samples and distributes them to the appropriate storage.
• Maintains designated laboratory equipment.
• Prepares samples for processing.
• Uses various laboratory computer systems for labeling, inquiry, results as needed.
• Disposes of bio-hazardous and chemical waste in the accessioning room.
• Assists with department quality and process improvement projects.
• Sets up supplies for the assigned work area
• Discards specimens as needed.
• Upholds all CLIA, CAP, NYS and other state regulations, as required.
• Call patients to verify and confirm personal information to identify samples
• Ensure accuracy of patient details in the lab's database, and update any discrepancies or changes.
• Update and document patient records in the Salesforce system
• Follow all HIPAA guidelines and confidentiality protocols to protect patient information at all times.

Education & Skills:

• High School degree
• Great organizational skills
• Clear and effective Communication skills
• Multitasking skills
• Must be able to speak/read/write in English
• Detail Oriented

TheSenior Process Engineer is responsible for designing, developing, optimizing and troubleshooting manufacturing processes in a manner that meets safety, quality and operational performance expectations. This position provides leadership and creativity in the formulation development, process development and optimization, scale up and manufacturing. The key function of this role is to identify and solve problems in the manufacturing process transfer and scale up, and deliver effective, safe and efficient manufacturing processes for parenteral drug products. The Senior Process Engineer is hands-on, able to handle multiple tasks with sound planning and communication and providing training and support to peers.

This role will:

• Analyze organic or inorganic pharmaceutical excipients to determine chemical or physical compatibilities with active drug molecules for the development of stable pharmaceutical product
• Evaluate changes in the composition/stability of pharmaceutical products due to changes in variables such as heat, light, or chemical catalysts for quantitative or qualitative analysis
• Propose and prepare formulations with different excipients or solvents to conduct experiments and analytical testing at laboratory scale
• Propose and develop lyophilization product and process or other complex formulation process such as liposome, TFF and viscous product
• Take an active part in scale-up and technology transfer of newly developed products from R&D to manufacturing
• Identify and order materials required to perform development and manufacturing
• Identify tooling and equipment required to perform development and manufacturing
• Create documents for laboratory/manufacturing operations and quality such as master batch records, study protocols, engineering batch record, process characterization reports, standard operating procedures (SOP), etc. Review these documents for their compliance with cGMP and FDA standards
• Due diligence on manufacturing process design and risk analysis to ensure operation safety, efficiency and quality
• Propose testing procedures for analyzing CQA and coordinate with quality control testing to ensure the quality of finished drug product
• Compile and analyze test information to determine process or equipment operating efficiency or to diagnose malfunctions
• Analyze in-process and release testing results to design, analyze, and control pharmaceutical manufacturing processes through the measurement of critical process parameters (CPP) which affect the critical quality attributes (CQA) of the pharmaceutical product
• Maintain ownership of assigned laboratory instruments to ensure proper working order and troubleshoot malfunctions when needed
• Study effects of various manufacturing techniques or packaging configuration on the composition or stability of pharmaceutical product
• Develop, improve or customize equipment, formulas, processes or analytical methods to maintain quality of pharmaceutical product
• Write technical papers or reports or prepare standards and specifications for processes, facilities, products, or tests
• Provide leadership in daily operations, and have employees incorporate these compliance practices into their daily routines
• Lead/support validation activities including equipment validation and process validation
• Lead problem solving and investigate quality events related to formulation process or batch records
• Propose and lead process improvement initiatives to improve operating performance and laboratory safety procedures to ensure compliance with the cGMP and FDA standards
• Lead or participate in root cause analysis and quality event investigation such as OOS and deviations
• Supervise, mentor and develop team members or relevant personnel across departments

This role requires:

• A minimum of three (3) years of experience in pharmaceutical research and manufacturing
• Bachelor’s degree or above in Chemical Engineering, Chemistry, Biology or Pharmaceutical Science
• Experience in sterile manufacturing is preferred
• Experience in lyophilization and terminal sterilization techniques are a plus
• Knowledge of parenteral drug product manufacturing
• Proficient with calculation, data analysis, statistics and applied mathematics