Careers
CSv Engineer
Minimal Qualifications:
Bachelor’s degree in Mechanic/Electrical/Chemistry/Computer Engineering preferred and minimum 3 years of experience.
CSV system development life cycle is required. Thorough knowledge of cGMP regulations related to CSV including 21 CFR Part 11 is required. Strong knowledge of system development life cycle is required. Knowledge/familiarity with U.S. and Global regulatory registration of drug products is preferred. Strong leadership skills and the ability to work in cross-functional team environments, as well as independently, and to manage multiple and competing projects are required.
Experience and Description of Position:
The purpose of this role is to develop and conduct appropriate procedures regarding the Qualification and Validation of company equipment, processes, Software and systems. Responsible for the development and execution of computer and/or automation systems validation in compliance with current Good Manufacturing Practices (cGMPs) and all other regulatory and/or guidance requirements such as Annex 11, GAMP and 21 CFR Part 11.
Preferred qualifications /Desired Skills :
Development of computer and automation systems validation ensuring compliance to required regulatory requirements.
Support activities include, but are not limited to, SOP creation, documentation generation, review and approval.
Activities also include change controls, assessment plans, risk assessment reports, compliance plans, user requirements, system and user acceptance testing protocols, traceability matrix, error reports/defect report forms and summary reports.
Compiles and analyses validation data and makes recommendations for changes and/or improvements.
May also investigate and trouble-shoot problems which occur and determine solutions.
Maintains all documentation pertaining to computer systems validation.
Participates on cross-functional project teams with the support of Development, Manufacturing, Engineering, Quality, and other groups.
Experience with Manufacturing and Packaging Equipment/Systems.
ENGINEER
Minimal Qualifications (Education and years of experience):
Bachelor's Degree in Engineering and 2 years of experience in Engineering in Pharmaceutical, Biotechnology or Medical Device Industry
Experience and Description of Position:
Experience in: Biotechnology experience, upstream processes, cell culture processes, harvest processes, bioreactor or fermenter experience preferred, bulk manufacturing, drug substance manufacturing.
Under general supervision, provides characterization of process optimization strategies and/or troubleshooting of operational issues in the operations, manufacturing, pilot plant or capital projects environment. Applies basic engineering principles to the design and implementation of system modifications, experiments and/or capital projects. Organizes, analyzes and presents interpretation of results for operational issues or engineering projects of minor scope and complexity. Provide solutions to a variety of technical problems of moderate scope and complexity.
Under general supervision will evaluate, select and apply standard engineering techniques and procedures. Assistance given for unusual problems. Perform assignments that have clear and specific objectives and require investigation of limited number of variables. Initiate and complete routine technical tasks. Prompt and regular attendance to workplace. Function as a technical expert to equipment or systems regarding troubleshooting operations. Frequently become actively involved in daily operations when required to meet schedules or to resolve complex problems. Routinely audit the operational performance and regulatory compliance of a moderate number of equipment items or systems of significant complexity. Work with research, manufacturing, maintenance, process development, utilities, facilities, quality assurance and/or validation departments in developing requirements and recommendations for system modifications. Work under the direct supervision of project managers to complete design, engineering, and construction projects within schedule and budget constraints. Work with consultants, architects and engineering firms on development of standard design documents. Obtain and critique quotes for equipment modifications or installations. Generate rudimentary project cost estimates and schedules
Preferred qualifications /Desired Skills:
Working knowledge of pharmaceutical/biotech processes. Familiarity with validation processes Familiarity with documentation in a highly-regulated environment. Ability to operate specialized laboratory equipment and computers as appropriate. Ability to interpret and apply GLPs and GMPs. Ability to apply engineering science to production. Able to develop solutions to routine technical problems of limited scope
Demonstrated skills in the following areas:
Problem solving and applied engineering. Basic technical report writing Verbal Communication Comprehensive understanding of validation protocol execution requirements.
Basic technical presentations Personal Organization Validation Protocol Writing Dealing with and managing change Technical (Equipment Specific) Analytical Problem Solving and Computer Literacy.
Project Coordinator
Minimal Qualifications (Education and years of experience):
BS in Engineering ( no civil engineer) and minimum 3 years of experience in Pharmaceutical, Biotechnology or Medical Device Industry
Experience and Description of Position:
The project coordinator will be responsible for ensuring the day-to-day operations and assigned project activities of assigned team(s) and that associated meetings, activities and events are executed in a professional, timely and collegial manner. Additional duties include the following:
Preferred qualifications /Desired Skills:
Generate, manage and close change controls to ensure changes occur with minimal operational impact and in compliance with client methodologies and requirements.
Oversee planning and preparation of internal and external team meetings and events, including documentation and tracking of next steps for each assigned project.
Work with team leads, and support associates to create and execute project work plan.
Identify and manage project dependencies and critical path.
Manage day-to-day developmental and operational aspects of projects.
Estimate resources and identify participants needed to achieve project goals.
Set and continually manage expectations with team members and other stakeholders.
Develop and deliver progress reports, requirements documentation, and presentations.
Succinctly summarize and document activities with providers and stakeholders.
Participate in the design, implementation, and evaluation of improvement projects.
Develop and execute qualification protocols as needed.
Quality Engineer
Qualifications (Education and years of experience):
Bachelor’s Degree, preferably in Engineering or related technical field. Generally requires 4-6 years related experience.
Experience and Description of Position:
The main focus of this assignment is to document sampling plan rationales using statistical techniques prescribed in the companies’ procedures. So the person must have some statistics knowledge. Also, as time permits there will be other actions assigned to this QE, per business needs. The main focus of this assignment is to document sampling plan rationales using statistical techniques prescribed in the Ethicon procedures. The Senior Quality Engineer plans, conducts and directs engineering projects or studies including complete projects requiring advanced knowledge of a specialized field. They apply comprehensive and diverse knowledge of engineering principles and practices within broad assignment areas. They may coordinate and direct activities of technical support staff and are responsible for technical development of assigned staff. The Senior Quality Engineer will utilize Quality Engineering tools and practices for the effective and efficient development, transfer and maintenance of products/processes throughout the product lifecycle. The incumbent will also utilize Quality Engineering principles and problem solving skills to improve and maintain products/processes that are aligned with the overall Quality and Business vision. He/she will utilize appropriate risk management to prevent unanticipated failure modes and improve capability of processes.
Preferred qualifications /Desired Skills:
Major Responsibilities & Duties: Business Improvements Support quality improvement initiatives such as process and product characterizations that lead to continuous / cost improvements. • Review/analyze the effectiveness of PDCA, Six Sigma, Kaizen, Lean Techniques and/or other improvement tools and programs. • Conduct benchmarking to develop more effective methods for improving quality • Supports the development of quality engineering and quality compliance with the right skill sets for new product introductions, and product life cycle management..
Compliance/Regulatory Review/analyze whether current product and processes (including actions or decisions conducted) are in compliance to standards such as the QSRs, ISO 13485, etc. • Champions compliance to applicable Global Regulations and standards (e.g. QSRs, ISO, EN and Medical Device Directive (MDD) requirements) including providing support during internal and external audits.
New Product/Process Introduction Partners with R&D and other cross functional partners to ensure the proper application of design controls, risk management and the investigation/correction of design failures/challenges. • Supports new product introduction as part of design transfer.
Product Quality, Control & Disposition and Performance Standards Conduct investigation, bounding. documentation, review and approval of non-conformances, CAPAs and customer complaints. Escalation of quality issues as appropriate. • Accountability and ownership for material identification, material segregation, classification of defect types including the successful application of these techniques on a day-to-day basis in manufacturing. • Analyze/review effectiveness of preventive and corrective actions. Review root cause investigation according to an established process. • Accountability and ownership of Quality metrics including maintenance and reviewing of leading and lagging indicators of quality.
Product/Process Qualification Approve IQ, OQ, PQ, TMV or Software Validation.
Production/Process Controls including Control Plans Partners with J&J Global Supply chain, Finished Goods and material suppliers to ensure appropriate application of process validation, process control, and risk management; and the investigation/correction of process failures when needed.
Conduct stakeholder analysis to ensure that customer CTQs are known and adequately addressed in control plan.
Develop measurement systems/capabilities, destructive tests, non-destructive tests for manufacturing processes
Develop control plans consistent with product classification, potential defect types, defect frequency, severity, patient risk, process capability, process controls, etc.
Develop, interpret and implement appropriate process monitoring and control methods consistent with the level of process/product risk.
Collect data and execute/conduct various analytical/statistical analysis and interpretation as part of process improvements and day-to-day support.
Develop, interpret and implement standard and non-standard sampling plans.
Assess effectiveness of measurement tools, destructive tests, non-destructive tests, measurement system analysis.
Accountability and ownership for sampling plans of all types including acceptability of risk given the product classification, potential defect types, defect frequency, severity, patient risk, process capability, process controls, etc. including assessing, applying and interpreting acceptance sampling standard for manufacturing data.
Assess and interpret common versus special cause variation in manufacturing processing and determine adequacy of current process limits.
Risk Mitigation Document, justify, review or analyze whether a proposed change to a process will not enhance the risk level in some way beyond capability of current controls or whether change will result in potential non-compliance to a required standard such as the QSRs.
Assess the need for risk mitigation techniques given product classification, potential defect types, defect frequency, severity, patient risk, process capability, process controls, etc. Determine effectiveness of these techniques on previously implemented improvements Strategic.
Ensures effective quality strategies are created for the validation of test methods, process and design.
Experience working in both an FDA and European regulatory environment is preferred. This position will require relevant experience working in manufacturing/operations.
In-depth knowledge of product/process Risk Management (FDA and ISO standards) is required. • Experience with a proven track record of implementing appropriate risk mitigation.
Technical training and experience using Statistics, Lean and Six Sigma Methodologies is required including Measurement System Analysis, SPC, DOEs, Reliability, etc.
Strong knowledge of statistical software packages is preferred with the ability to preview, graph and analyze data and be able to present data that facilitates/drives decision making.
The ability to perform "hands on" troubleshooting and problem solving is required. The ability to think on the feet and providing sound judgment is highly desired.
Good technical understanding of manufacturing equipment and processes is required.
Understanding of the NPI (New Product Introduction) process and Process Validation expertise is preferred.
A thorough understanding of GMP/ISO regulations and validation regulations is preferred.
Advanced knowledge and proven leadership in the areas listed in the Duties and Responsibilities associated with the position.
Demonstrated project management and project leadership abilities are required.
VALIDATION SPECIALIST
Qualifications (Education and years of experience):
Bachelor’s Degree, preferably in Engineering, Computer Science 5 to 8 years of experience in the required field.
Experience and Description of Position:
Experience in the design and execution of Commissioning and Qualification protocols such as IQ, OQ, PQ and CSV protocols. Experience in the development of URS, DFS, DDS, SAT, FAT, and Commissioning Documentation and/or Protocols. Experience in facilities and utilities commissioning and qualification such as; HVAC, Chilled Water, Steam Generation, Purified Water, Fire Protection Systems, Compressed Air, etc.
Must be able to manage multiple tasks, be able to work independently, long hours, irregular shifts and have strong oral and written communication skills. Customer focus and being a team player are a must.
Preferred qualifications /Desired Skills:
Review and process change controls to ensure compliance with established procedures and applicable standards.
Regulatory Affairs Manager
Qualifications (Education and years of experience):
BS degree in Science (e.g. Biology, Chemistry, Biochemistry) and 5 years of experience in Quality area
Experience and Description of Position:
The Regulatory Affairs Manager will provide expertise in translating chemistry, manufacturing and control (CMC) regulatory requirements into practical, workable plans. Primary responsibilities include develop regulatory strategies for reporting post approval changes, preparation of critical CMC submission documentation, assessment of change control, non-conformances and other quality related documents, and the preparation of the annual report of minor changes. Participate in general regulatory affairs and regulatory compliance functions of the company.
Functions:
Develop and execute CMC related regulatory strategies support the introduction of new products to the site and for manufacturing related post-approval changes.
Serve as the regulatory CMC representative on specific project teams. Provide team with guidance on regulatory requirements.
Support the preparation and responses for global marketing applications and regulatory submissions related to changes at the site. Review and assess the regulatory impact of proposed manufacturing related changes, non-conformance events and other GMP related documents.
Lead the preparation of the Annual Report of Minor Changes for approved products manufactured at the site.
Support the generation of facility and GMP related document to support emerging market registrations.
Provide regulatory expertise and policy support for good industry practices (GMPs).
Preferred qualifications /Desired Skills:
Regulated industry, science or GMP practice experience.
Understanding of drug development or drug commercial process.
Experience in the development, review and maintenance of global regulatory dossiers.
Ability to review regulatory documents for accuracy and adherence to regulatory requirements, noting deficiencies and inconsistencies.
Ability to communicate with corporate business functions and internal business partners.
Strong oral and written communications, managing and adhering to timelines, negotiation skills, integrity and adaptability.
Successfully work within a team/partnership environment and as an individual contributor, with a high level of professionalism.
Good leadership skills and strong communication skills.
Fundamental project management skills.
Good analytical problem solving skills.
Strong communication skills - oral and written (English and Spanish)
Organizational skills.
CLEANING VALIDATION SPECIALIST
Qualifications (Education and years of experience):
BS degree in Engineerin or Science (e.g. Biology, Chemistry, Biochemistry) and 5 years of experience in Quality area
Experience and Description of Position:
The Cleaning Validation Specialist will provide expertise in 5+ years of Cleaning Validation experience. Fully Bilingual.
Functions:
Develop and execute CMC related regulatory strategies support the introduction of new products to the site and for manufacturing related post-approval changes.
Preferred qualifications /Desired Skills:
Regulated industry, science or GMP practice experience.
AUTOMATION ENGINEER
Qualifications (Education and years of experience):
BS degree in Science (e.g. Biology, Chemistry, Biochemistry) and 5 years of experience in Quality area
Experience and Description of Position:
The Automation Engineer will provide expertise in
Functions:
Develop and execute CMC related regulatory strategies support the introduction of new products to the site and for manufacturing related post-approval changes.
Estimate test efforts, analyze and communicate test results and participate in day to day QA Activities. Add to our company’s performance and availability testing efforts and improve the test frameworks, tools and technologies used by the organization to maintain a high quality bar o This can also include writing specialized testing tools for our software platform.
Work with Development, Test and Product Management to design and implement test and validation strategies.
Execute and manage test cases and results; report on test and defect metrics.
Create, execute and troubleshoot automated test scenarios across our systems.
Contribute to robust, scalable, and high quality test automation solutions for functional, regression and performance testing
Identify required improvements in the test and development processes; make contributions to our automation tools that address specific needs.
Maintain a high quality bar in a complex and constantly evolving workspace
Preferred qualifications /Desired Skills:
Regulated industry, science or GMP practice experience.
Experience with software testing and automated test techniques with a strong focus on quality throughout the entire software development cycle.
Good knowledge of object oriented programming, along with requisite coding and debugging skills.
Design and development skills
Proven ability to translate functional requirements and use cases into working test plans and test cases.
