Suno Api Docs Jobs in Usa

1,458 positions found — Page 73

Quality Supervisor
✦ New
Salary not disclosed
Houston, TX 3 hours ago

Quality Supervisor / Quality Lead / Lead Quality Engineer required to oversee the quality assurance activities at a leading Rotating Equipment manufacturer and solutions provider based in Houston.


Quality Supervisor / Quality Lead / Lead Quality Engineer will be responsible for managing and overseeing inspection and testing processes to ensure that all activities align with company standards, customer requirements, and relevant industry codes. This role will directly support the resolution of quality issues and work towards continuous improvement on the production floor.


Quality Supervisor / Quality Lead / Lead Quality Engineer will work closely with operations, engineering, and project management teams to meet quality objectives, drive improvements, and maintain ISO 9001 certification.


Quality Supervisor / Quality Lead / Lead Quality Engineer Package

Circa $110,000

PTO

401K


Quality Supervisor / Quality Lead / Lead Quality Engineer Responsibilities

  • Lead and coordinate the activities of a quality team to ensure accuracy and consistency in all inspection and testing activities.
  • Supervise the inspection of rotating equipment components (compressors, turbines, steam actuators) to ensure dimensional, metallurgical, and non-destructive testing compliance.
  • Review and approve non-conformance reports, ensuring all documentation is accurate, dispositions are appropriate, and timely closure is achieved.
  • Coach, mentor, and develop team members to elevate technical proficiency and prepare them for higher levels of responsibility.
  • Support root cause analysis and corrective/preventive action processes to ensure quality improvements.
  • Ensure that all inspection equipment is calibrated and that NDT inspector certifications are up to date.
  • Collaborate with operations and engineering teams to resolve any quality issues affecting production.
  • Assist in customer and third-party audits, ensuring inspection documentation is prepared and available.
  • Track inspection performance, identify trends in defects, and report key metrics to management.
  • Ensure compliance with the company’s QMS (ISO 9001) and relevant industry codes (API, ASME, AWS).


Quality Supervisor / Quality Lead / Lead Quality Engineer Requirements

  • 5+ years of experience in quality assurance or inspection within a manufacturing or service environment.
  • 2+ years of supervisory experience, with a strong ability to lead without direct authority.
  • Expertise in rotating equipment, including the inspection, assembly, and repair of compressors, turbines, and related components.
  • Proficiency with dimensional inspection tools, NDT methods (MT, PT, UT, RT preferred), and welding processes.
  • Familiarity with machining practices and processes.
  • Knowledge of welding inspection and applicable codes (ASME, AWS) is advantageous.

Relevant professional certifications in quality or health & safety preferred.

  • Ability to adapt to changing operational schedules and priorities, working across multiple sites as needed.
  • Authorized to work in the United States and able to pass pre-employment drug, alcohol tests, and background checks.
Not Specified
Director of Quality Assurance - Insurance Industry
✦ New
🏢 LHH
Salary not disclosed
Orlando, FL 3 hours ago

Role: Director of Quality Assurance- INSURANCE INDUSTRY

Location: Must be able to go onsite in Lake Mary, FL

Salary: $210k with 3% bonus

Company benefits include Health Care, Dental and Vision Care, 401K


MUST HAVE Successful history of driving modernization of testing frameworks and practices in Financial Services preferably across Personal and Commercial Lines Insurance



What you can expect as a Director of Quality Engineering:

• Serve as a trusted advisor to Business, Product, and Technology leaders, championing enterprise-wide Quality Engineering practices across core platforms, digital channels, and integrations.

• Define, own, and govern the enterprise Quality Engineering strategy, roadmap, operating model, and standards aligned to business transformation and technology modernization.

• Lead the shift from traditional testing to engineering-driven, automation-first, and risk-based quality practices to reduce manual testing effort and accelerate delivery.

• Embed quality as a shared accountability across Agile and Product teams through Shift Left, DevOps integration, and continuous quality practices.

• Influence enterprise technology strategy by advocating for capabilities that improve testability, observability, automation, and release confidence including selection of tools.

• Scale automation coverage across functional, regression, integration, performance, and non-functional testing to reduce cycle time and dependency on manual testing.

• Embed Quality Engineering into cloud, digital, and modernization programs to ensure quality at scale.

• Establish enterprise quality governance covering planning, execution, defect management, release readiness, and post-release validation.

• Define and operationalize enterprise KPIs and dashboards (automation coverage, escaped defects, release health, cycle time, defect trends, etc.) to enable data-driven decision-making.

• Provide executive-level reporting on quality risks, readiness, trends, and remediation plans.

• Ensure regulatory, compliance, and audit requirements are supported through traceability, reporting, and controlled quality processes.

• Align quality priorities with business risk, customer impact, and portfolio objectives.

• Lead and develop global Quality Engineering teams across onshore, nearshore, and offshore locations.

• Define clear accountability through operating models and RACI, enabling managers and leads to own delivery while the Director focuses on strategy and transformation.

• Mentor and grow future Quality Engineering leaders and foster a culture of high performance, ownership, and continuous improvement.

• Own Quality Engineering financial strategy including budgets, forecasts, vendor partnerships, contracts, and SOWs ensuring value, scalability, quality outcomes, and alignment with enterprise goals.


What we are looking for as a Director of Quality Engineering:

• At least 15 years of experience in Quality Assurance / Quality Engineering with 10 years of leading Quality Engineering teams on large enterprise transformation (P&C insurance or financial services preferred).

• Successful history of driving modernization of testing frameworks and practices in Financial Services preferably across Personal and Commercial Lines Insurance.

• Hand-on experience with Playwright, Selenium, JMeter, Gatling, LoadRunner and other cloud‑based performance testing tools.

• Proven leadership in building automation frameworks preferably around Guidewire Insurance Suite.

• Experience converting high-value regression and smoke tests from manual to automated suites, prioritizing risk and ROI, and integrating them into CI/CD.

• Experience in modernizing enterprise testing practices through APIs, events, microservices, and data platforms, ideally within Guidewire Insurance Suite, and crafting Quality Engineering strategies that cover both the core and connected digital ecosystem.

• Strong background in leading geographically spread Quality Engineering teams and external partners, ensuring efficiency and accountability through structured RACI models.

• Strong leadership, stakeholder management, communication skills — able to liaise between various departments effectively.

• Strong analytical, problem-solving skills and attention to detail.

• Proven experience of managing multiple priorities in a fast-paced environment.

• Ability to perform well and professionally in a demanding, high performance IT organization.




Equal Opportunity Employer/Veterans/Disabled

Military connected talent encouraged to apply

To read our Candidate Privacy Information Statement, which explains how we will use your information, please navigate to Company will consider qualified applicants with arrest and conviction records in accordance with federal, state, and local laws and/or security clearance requirements, including, as applicable:

  • The California Fair Chance Act
  • Los Angeles City Fair Chance Ordinance
  • Los Angeles County Fair Chance Ordinance for Employers
  • San Francisco Fair Chance Ordinance

Massachusetts Candidates Only: It is unlawful in Massachusetts to require or administer a lie detector test as a condition of employment or continued employment. An employer who violates this law shall be subject to criminal penalties and civil liability.

Not Specified
Senior Machine Learning Engineer
Salary not disclosed
Palo Alto, CA 6 days ago

Senior Machine Learning Engineer (GenAI and Agentic Systems)

Location: Palo Alto, CA (Hybrid )

Role Type: Full-Time / Permanent

Summary


Our client, a pioneering HealthTech AI firm in the Bay Area, is seeking a high-calibre Senior Applied AI Engineer to bridge the gap between advanced Machine Learning and robust Software Engineering. This is an end-to-end ownership role: you will be responsible for designing the logic, building the architecture, and deploying the final services.


Core Responsibilities


  • Architect AI Workflows: Design and implement sophisticated agentic workflows and automation sequences that power clinical decision-making.
  • System Design & Integration: Build the backend infrastructure, scalable REST APIs, and data services required to support high-concurrency AI applications.
  • Rapid Deployment: Maintain a high-velocity shipping cycle, moving from prototype to production-grade implementation in days.
  • Model Orchestration: Select, fine-tune, and evaluate the performance of various LLMs (including OpenAI, Anthropic, and open-source models) for specific healthcare tasks.
  • Full-Stack ML: Own the pipeline from data ingestion and time-series forecasting to real-time classification and model monitoring.


Technical Profile


  • Computer Science Mastery: Expert knowledge of algorithms, data structures, and distributed systems.
  • Software-Heavy Background: Professional-grade Python skills. You should be comfortable with software design patterns, testing, and CI/CD.
  • Machine Learning Fundamentals: * Deep understanding of Core ML topics: classification, regression, and clustering.
  • Specific experience in Time Series Forecasting and temporal data analysis.
  • Proficiency in Generative AI: RAG architectures, prompt optimization, and agent frameworks.
  • Infrastructure: Experience deploying services to cloud environments (GCP preferred) and a solid grasp of MLOps and pipeline automation.
  • Education: BS in Computer Science or related field + 4 years of experience, or an MS + 2 years of experience.


Cultural Fit


  • Startup Agility: You possess the "scrappiness" to solve problems with limited resources but the rigor to ensure those solutions are enterprise-grade.
  • The "Generalist" Mindset: You enjoy working across the entire stack and are not afraid to dive into data engineering or infrastructure when needed.
  • Mission-Oriented: You are motivated by the prospect of using AI to significantly improve patient outcomes and healthcare efficiency.


What’s Offered



Our client provides a highly competitive package, including a strong base salary, meaningful equity, and comprehensive premium healthcare benefits. You will join a world-class team of engineers in a collaborative, hybrid environment.

Not Specified
Global Product Quality Specialist
Salary not disclosed
Princeton, NJ 6 days ago

Global Product Quality Specialist

12-month Contract

Remote- EST Hours


Responsibilities:

  • Quality Systems Support:
  • Work collaboratively with internal and external partners to ensure deviations, investigations, OOS/OOTs, CAPAs and change controls adhere to quality system requirements and current GMP expectations.
  • Support of regulatory submissions, annual reports and preparation of annual product quality reviews
  • Inspection readiness for Internal and external audits
  • Compile metrics for continuous improvement initiatives
  • Assist in the writing of Quality Agreements
  • Documentation Review:
  • Review of API, DP and Packaging batch records
  • Review of test methods, component specifications, validation protocols/reports, BOM
  • Review of stability protocols and reports, and data in LIMS
  • Operational QA Support:
  • Work with external CDMOs and laboratories in the review of quality events, change controls, data review, and batch record documentation
  • Creates and/or ensures on-time closure of Quality records in TrackWise Digital (batch records, deviations, change controls, investigations, CAPAs and effectiveness checks)
  • Uploads and routes documents for approval in the company Electric Documentation Management System (Veeva) and DocuSign
  • Project QA Support:
  • Represent quality on cross-functional teams and provide support to ensure compliance with GMPs, FDA expectations, product specific requirements, and company standards are consistently met
  • Ensure the review and release of clinical and commercial lots meet expected timelines to maintain an uninterrupted product supply

Qualifications:

  • BS Degree in scientific discipline (e.g., Chemistry, Biology, Pharmacy, Engineering) or equivalent experience in a GMP-regulated environment
  • 4 to 7 years of experience working within Pharmaceutical Quality, Engineering, Production or QC/Analytical Development function
  • Ability to author and/or provide clear, concise, and technically accurate feedback on GMP documents (SOPs, deviations, CAPAs, investigations, protocols, reports)
  • Attention to detail required to perform thorough document review, accurate data verification, and consistent application of right first time principles
  • Working knowledge of ICH guidelines (e.g., Q7/Q8/Q9/Q10, Q12) and 21 CFR Parts 210/211 and/or EU GMPs, with the ability to apply these requirements to real-world manufacturing, testing, documentation, and release processes
  • Experience with at least two QMS elements (e.g. Deviation, CAPA, Change Control)
  • Strong written and verbal communication skills; ability to collaborate with cross-functional teams
  • Proficiency with MS 365 (Word, Excel, PowerPoint, SharePoint/Teams).
  • Experience with electronic QMS/eDMS (TrackWise, Veeva, LIMS) systems is a plus.
Not Specified
Technical Project Lead
Salary not disclosed
Philadelphia, PA 6 days ago

Job Title: Technical Project Lead

Location: Philadelphia, PA

Schedule: Hybrid (Onsite Tuesday–Thursday)


Overview

We are seeking an experienced Technical Lead to oversee the design, development, and delivery of integrated, technically sound solutions across complex programs and projects. This role will serve as the primary technical point of contact, ensuring successful execution of all ISD technical deliverables while partnering closely with Project and Program Managers.


Responsibilities

  • Own end-to-end delivery of integrated technical solutions for assigned projects and programs.
  • Serve as the primary technical liaison to Project/Program Managers and ISD leadership.
  • Provide technical leadership for all ISD deliverables, ensuring alignment with project scope, timelines, and quality expectations.
  • Maintain accurate project schedules and status reporting across time, cost, and scope.
  • Manage and track technical resource plans, budgets, and burn rates; escalate risks as needed.
  • Develop and validate technical work estimates throughout the project lifecycle.
  • Identify technical resource requirements and ensure accurate time tracking within enterprise systems (e.g., Empire Time, Clarity).
  • Participate in project meetings and take ownership of ISD technical components and deliverables.
  • Troubleshoot, resolve, and act as the escalation point for complex technical issues.
  • Ensure on-time, on-budget, high-quality delivery of all technical components.
  • Promote strong team collaboration and ensure consistent, cohesive delivery across technical teams.
  • Communicate effectively with project stakeholders regarding technical performance, risks, and issues.
  • Provide consultative support on technical matters to other organizational teams (e.g., Informatics).
  • Oversee quality across all technical project artifacts and ensure all required SDLC documentation is completed.
  • Maintain accurate monthly Estimate-to-Complete (ETC) forecasts for assigned projects.


Qualifications

  • Bachelor’s degree preferred or equivalent professional experience.
  • 5+ years of experience designing, developing, and supporting APIs using MuleSoft Anypoint Platform or similar middleware technologies.
  • 5+ years of experience as a developer and/or technical lead.
  • Strong background with Agile and Waterfall methodologies.
  • Experience with TFS and Azure DevOps for code management, testing, and review.
  • Hands-on technical expertise with prior development experience and familiarity with SDLC processes.
  • Healthcare EDI experience is beneficial but not required.
  • Must have an Android or iOS device compatible with the Microsoft Authenticator app.
Not Specified
SFDC Technical Lead -- AZHDC5751096
Salary not disclosed
Santa Rosa, CA 6 days ago

Job Title – Tech Lead, SFDC

Location – SFO- Bay Area, CA - Hybrid

Duration – Long Term Contract (C2C, W2)


We are looking for a Salesforce Technical Lead with strong Healthcare Cloud experience who is highly hands-on and comfortable with Apex coding, complex SOQL queries, and custom development.

Key Responsibilities:

- Lead end-to-end Salesforce implementations with a focus on Salesforce Health Cloud

- Design and develop custom Apex classes, triggers, batch/queueable jobs, and complex SOQL/SOSL queries

- Build and optimize Lightning Web Components (LWC) and Aura components

- Perform hands-on development while mentoring junior developers and reviewing code

- Design and implement integrations using REST/SOAP APIs, Platform Events, and middleware

- Ensure data security, compliance, and HIPAA standards in healthcare solutions

- Own technical architecture, troubleshooting, and performance optimization

- Collaborate closely with business stakeholders, product owners, and cross-functional teams

Required Skills & Experience:

- 13+ years of Salesforce experience with 5+ years as a Technical Lead

- Strong expertise in Salesforce Health Cloud

- Expert-level Apex development, including triggers, async Apex, and governor limit optimization

- Advanced experience writing SOQL queries and handling large data volumes

- Hands-on experience with LWC, Visualforce (as needed), and Salesforce flows

- Experience integrating healthcare systems (FHIR, HL7, EHR/EMR preferred)

- Solid understanding of Salesforce security model, data sharing, and compliance (HIPAA)

- Experience with CI/CD, DevOps tools, and source control (Git)

Not Specified
Principal Scientist
Salary not disclosed
Waterloo, IA 3 days ago

Our pharmaceutical client is seeking a Principal Scientist who will be responsible for evaluating and interpreting analytical results, as well as developing, validating, and transferring analytical methods for APIs, intermediates, and raw materials. If you are someone who wants to be apart of a highly technical environment with a lot of growth, this role may be the one for you!

Responsibilities:

  • Safely and effectively develop, establish, and validate analytical testing methodologies used to control raw materials, production intermediates, and final products
  • Actively participate in teams assembled to investigate and solve analytical technical issues within Analytical Development, Chemical Development, Process Support Group and Quality Control.
  • Perform analytical chemistry assays based on new and existing methodologies
  • Operate analytical instrumentation such as HPLC, GC, GC/MS, FTIR, Titrator, Particle Size Analyzer
  • Write technical reports to document analytical methods
  • Maintain laboratory notebooks documenting work
  • Maintain compliance with GMP SOPs and DEA regulations
  • Transfer documented analytical methods to the QC and Process Support Group departments
  • Set up new or existing analytical methods for compound identification, purity and potency testing.
  • Coordinate off-site testing as necessary
  • Conduct testing of analytical samples for the Chemical Development Department as needed.
  • Qualify reference materials.
  • May also perform other duties as required.

Qualifications:

  • Ph.D. in Chemistry or related field with minimum 6 years of experience or M.S. in Chemistry or related field with minimum 10 years of experience or B.S. degree in Chemistry or related field with 14 years of experience in lab environment, pharmaceutical experience preferred.
Not Specified
Calibration Technician
Salary not disclosed
Devens, MA 2 days ago

Discover Veranova:


At Veranova, we believe people are our most important asset, and we are dedicated to building the most talented workforce in our industry. Our commitment to uncompromising focus on quality, compliance, safety, and excellence in delivery shapes everything we do. We are not just looking for skills; we are seeking innovative individuals who have a mindset open to learning and growth, and a desire to make a difference.


Veranova is a global leader in the development and manufacturing of complex active pharmaceutical ingredients (APIs) for pharma and biotech customers. With deep technical expertise and impressive flexibility, we develop solutions and processes that support and accelerate innovation. 


Join us on our mission to enable current and next-generation therapeutics to improve and save the lives of patients. 


Role Overview:


Perform calibration, maintenance, troubleshooting, and installation of plant and lab instrumentation and control equipment. Enter and maintain repair, maintenance, and calibration data into computerized maintenance management systems.


Core Responsibilities:                                                              



  • Collaborate with cross-functional teams to drive impactful projects. 
  • Foster a culture of openness and creatively, encouraging diverse perspectives. 
  • Manage and execute the calibration program for both the Devens and North Andover sites.
  • Perform calibration scheduling and history tracking utilizing Computerized Maintenance Management Systems.
  • Install, maintain, and troubleshoot plant and lab instrumentation and control equipment.
  • Maintain inventory levels for repair and critical spare parts.
  • Manage activities and schedules for outside contracted services.
  • Generate operating and maintenance Standard Operating Procedures (SOPs) for calibration and preventative maintenance activities.
  • Develop equipment specifications and assist in process system designs.
  • Conduct formal investigations of equipment and system problems using root cause process.
  • Document all calibrations on Regulatory Asset Management System.
  • Additional assignments/ duties to support team objective and contribute to the Veranova mission may evolve based on business needs. 

 


Qualifications: 


 


Required


 



  • High School Diploma or equivalent with 5-8 years related instrumentation experience within a pharmaceutical or chemical environment.
  • AA in engineering or other related technical field with 2-5 years related instrumentation experience within a pharmaceutical or chemical environment.
  • Demonstrate attention-to-detail, problem solving, and ability to multi-task
  • Ability to physically enter equipment and confined areas for maintenance purposes
  • Able to climb ladders and stairs and work from building roofs and heights
  • Able to wear various types of respirators, protective clothing, and hearing protection
  • Able to read and interpret sketches, diagrams, and blueprints
  • Able to calculate various measurements using basic math skills.
  • Experience working in an environment that utilizes safety improvement processes, lock-out/tag-out, hot work, and other OSHA based programs.
  • Experience with Microsoft Office and other job-related software.



Preferred





  • Experience in a GMP environment
  • Formal process control (DeltaV) and computerized Maintenance System experience
  • Prior Forklift certification
  • Specialized training in inventory control principles.

 


Special Factors 



  • While performing the duties of this job, it is required to stand, walk, use fingers and hands to feel objects, tools, or controls; reach with hands or arms; climb or balance, stoop, kneel, crouch, or crawl when necessary for job activity.
  • Must be able to lift and/or move up to 50 pounds and occasionally life and/or move more than 100 pounds.
  • Must be able to travel between Devens and North Andover locations when necessary.
  • Must be able to work rotating shifts/hours when needed, including nights and weekends.

 


Pay Range – Hourly Rate: $35.00 - $45.00 per hour


Our Commitment:



  • Health & Wellness: Comprehensive health & wellness benefits. Access to mental health resources and wellness programs. Generous PTO and holiday pay policies. 
  • Financial Wellness: Veranova is committed to fair and transparent compensation practices. This includes a competitive base salary, eligibility for performance-based bonuses, and an attractive 401(k) Plan with company match. Salary ranges reflect the scope and expectations of the role, and are based on market data, internal equity, and role-specific factors. Final compensation may vary depending on experience, skills, education, and business needs.
  • Professional Development: Opportunities for continuous learning through LinkedIn Learning, workshops, conferences, and mentorship. Tuition Assistance for Undergraduate and Graduate degree programs.
  • Inclusive Culture: At Veranova, an inclusive culture is integral to our values. We welcome people with diverse experiences and perspectives who share our mission to improve and save lives. Even if you don’t meet every qualification, we encourage you to apply. Veterans, first responders, and those transitioning from military to civilian life bring valuable skills that strengthen our team.

Additional Information:


Applicants for this role must be authorized to work in the United States without further employer sponsorship.  


Agency and Search Firm Representatives: Veranova does not accept unsolicited resumes from agencies and/or search firms for this job posting. 


All your information will be kept confidential according to EEO guidelines.


Veranova is an Equal Opportunity Employer. It is the policy of Veranova to provide equal employment access and opportunity to all persons regardless of age, race, color, national origin, religion, sex, sexual orientation, gender identity and/or expression, physical or mental disability, genetic information, citizenship, marital status, veteran status, or any other characteristic protected by federal, state, or local law.


All applications are carefully considered, and your details will be stored on our secure Application Management System. This is used throughout Veranova for the selection of suitable candidates for our vacancies as they arise. Veranova respects your privacy and is committed to protecting your personal information. For more information about how your personal data is used please view our privacy notice.

Not Specified
Manager Software Engineering
Salary not disclosed
Tulsa, OK 2 days ago

JOB SUMMARY:

Responsible for the development, planning and implementation of CommunityCare’s strategic software engineering goals. Manages the software engineering team and is responsible for the development and maintenance of all applications.

KEY RESPONSIBILITIES:

  • Leadership responsibilities will include team development, training, mentoring, direct supervision and project management.
  • Working with technical staff to identify problems, solutions and develop requirements leading to the implementation of strategic initiatives.
  • Responsible for departmental metrics and staff development.
  • Performs other duties as assigned.

QUALIFICATIONS:

  • Strong knowledge of systems development life cycle including CI/CD.
  • Experience deploying solutions in a public cloud environment (Azure/AWS).
  • Experience integrating with external systems via API.
  • Strong knowledge of C# or Java and Angular.
  • Must be able to manage and motivate all levels of technical staff through Senior Engineers.
  • Knowledge of contracting, negotiating and change management.
  • Possess strong oral and written communication skills.
  • Ability to motivate teams to produce quality materials within tight time frames and simultaneously manage several projects.
  • Proven leadership of technology teams with a successful track record leading and managing technology services and operations in a dynamic environment.
  • Adept with technology systems, network design, implementation and maintenance as well as strong background in security technologies.
  • Ability to converse and write fluently in English.
  • Successful completion of Health Care Sanctions background check.

EDUCATION/EXPERIENCE:

  • Bachelor's degree in business or computer science.
  • Minimum three years’ experience in information technology management position.
  • Must be able to maintain and preserve information of a highly confidential nature.
Not Specified
Validation Scientist
Salary not disclosed
Sellersville, PA 2 days ago

JOB OVERVIEW:

The Validation Scientist position encompasses all areas of Technical Services with primary focus on technology transfer, scale-up, process optimization, process/packaging validation, commercial production technical support as well as equipment qualification and cleaning validation support.


KEY ROLES/RESPONSIBILITIES:

  • Lead and execute projects such as technology transfer, scale-up, process optimization process/packaging validation as well as equipment qualification and cleaning validation support to meet critical project deadlines.
  • Provide technical support in the investigation of manufacturing incidents and major deviations. Assure thoroughness of investigation and documentation as well as implementation of preventive/corrective actions as necessary.
  • Conduct commercial production technical support activities such as qualification of alternate suppliers of API, excipients and packaging components, equipment change parts, process parameters, yield limits, hold time studies, etc.
  • Execute utility and process equipment qualification support activities such as installation, operational and performance qualifications, periodic reviews, investigations, assessments, review change control and non-routine maintenance requests, out of specification calibrations, etc.
  • Perform cleaning validation support activities such as execution of cleaning validation and verification studies, hold time studies, investigations, assessments, justifications, maintain cross contamination program, etc.
  • Develop and/or execute experimental designs and approaches to resolve technical problems and utilize engineering standards, principles, concepts, equations as well as statistical techniques.
  • Prepare and review documents to support projects, such as laboratory notebooks, protocols, reports, assessments, justifications, investigation reports, regulatory submissions, master batch records, change control, etc.
  • Complete and document physical sampling and testing such as loss on drying, particle size distribution, bulk density, viscosity, pH, tablet weight, thickness, hardness and friability; sample for analytical and microbiological testing.
  • Author and periodically update assigned Standard Operating Procedures (SOPs) for the department.
  • Represent Technical Services at project team meetings and provide sound technical advice.
  • Coordinate and interface with Operations, Facility Engineering, Quality Control, Quality Assurance and Regulatory Affairs groups to assure successful project execution.
  • Directly interact with Piramal Pharma Solutions clients.
  • Maintain regulatory compliance within the function and follow site safety, health, and environmental policies and procedures.


EXPERIENCE:

  • Minimum of a Bachelor's degree in a scientific discipline (e.g., Chemical Engineering, Pharmaceutics, Pharmacy, Chemistry or equivalent) with a minimum of 3 years experience in Technical Services, Process Engineering, Process Validation, Formulation or related field in the pharmaceutical industry.
  • Experience in laboratory and production scale manufacture of solid oral, liquid and semi-solid dosage forms using equipment such as comminuting mills, high-shear granulators, fluid bed dryers, blenders, tablet presses, tablet film coaters, encapsulates, low and high-shear mixing vessels, homogenizers, pumps, packaging, etc.
  • Working knowledge of cGMP (Current Good Manufacturing Practices) regulations, SUPAC guidance, and general compliance expectations.
  • Working knowledge of investigational techniques, including but not limited to root cause analysis, risk assessment impact evaluation, and technical report writing.
  • Must possess research and problem solving abilities and be capable of producing detailed documentation, understand and make generalized and specific conclusions from project data.
  • Technical writing experience is required with attention to detail skills essential.
  • Must be able to work in a team environment with effective project planning/management, analytical thinking, organization, and execution skills.
  • Must have proficiency in the Microsoft Office Suite programs.
  • Demonstrated professionalism and excellent communication skills with internal and external personnel are essential.
  • Ability to work effectively managing multi projects at a fast pace withcross-functional departments and manage priorities to meet timelines.
  • Must be innovative, proactive, resourceful and committed to continuous improvement.
  • Working knowledge of cGMP data management systems (EDMS, Trackwise, and/or SAP) is preferred.


WORK ENVIRONMENT:

The position requires the ability to work in ahigh demand office and manufacturing setting with time spent performing "on the floor" activities in laboratory and manufacturing areas. The position may require extended hours including evenings and weekends as well as work hours on 2nd and 3rd shifts depending on project needs.

Not Specified
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