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filler@godaddy.com
Signed in as:
filler@godaddy.com
GxP Impact was designed to be the “next generation” multifaceted strategic planning, cGMP validation and consulting firm. Our talented staff of pharmaceutical industry professionals produces cost-effective, practical solutions for both project resourcing and ongoing staff augmentation. Our highly experienced team has exceptional experience in the selection and validation of equipment, facilities, clean utilities and manufacturing-related computer control systems in both cGMP and cGLP environments.
Opportunities to join this amazing company are listed below. If interested in applying and you meet the qualifications and requirements, please forward your resume to careers@gxpimpact.com. Our recruiting team will review your background and get in touch if we feel there is a good fit.
LOCATIONS: East Coast
BRIEF DESCRIPTION:
As an Asset Management and Reliability Engineer, you will play a critical role in improving the performance, integrity, and cost-efficiency of our customers' assets. You will work closely with multiple departments, including operations, maintenance, and finance, to identify and implement best practices. This role includes the implementation of reliability best practices and management of asset master data within our clients' Computerized Maintenance Management Systems (CMMS).
JOB RESPONSIBILITIES:
1. Develop Asset Management Strategies and Plans: Formulate long-term asset management plans in line with business objectives and industry best practices.
2. Lifecycle Analysis: Conduct studies to understand the complete lifecycle of assets, from procurement to decommissioning.
3. Condition Monitoring: Implement and oversee condition-based monitoring programs to track the health of key assets.
4. Reliability Analysis: Utilize tools such as Failure Modes and Effects Analysis (FMEA), Root Cause Analysis (RCA), and Reliability-Centered Maintenance (RCM) to analyze asset reliability.
5. Performance Metrics: Develop and monitor Key Performance Indicators (KPIs) to gauge asset performance and reliability.
6. Cost Optimization: Analyze cost data to identify opportunities for cost reduction and efficiency gains.
7. Maintenance Planning: Work closely with maintenance teams to plan and prioritize activities based on asset criticality.
8. Risk Management: Perform risk assessments to identify vulnerabilities and recommend mitigations.
9. Technical Support: Provide engineering expertise to solve complex reliability issues and consult on asset modifications or upgrades.
10. Continuous Improvement: Implement continuous improvement initiatives related to asset reliability and integrity.
11. Master Data Management Responsibilities - Design, Implement, and Deliver various CMMS/EAM/ERP systems:
o Data Gathering: Collect asset information and specifications for entry into CMMS.
o Data Standardization: Standardize nomenclature, categories, and other data attributes across all platforms.
o CMMS Customization: Tailor CMMS solutions to better align with client-specific asset management needs.
o Data Integration: Coordinate with IT teams to integrate CMMS data with other enterprise systems, such as ERP or EAM.
o PM Optimization: Develop proactive maintenance procedures to reduce and/or increase PM’s based on data/results of historical trends and mechanic/technician field experience.
o User Training: Educate end-users and stakeholders on the proper usage and benefits of the CMMS system for master data management.
o Reporting: Generate reports and analytics to provide insights into asset performance, maintenance, and costs.
o Customer Liaison: Serve as the primary point of contact for client queries regarding master data within their CMMS.
o Analyze asset data to identify trends, make recommendations, and implement changes.
QUALIFICATIONS:
1. Bachelor’s degree in engineering or related field, or equivalent military experience.
2. A minimum of 3-5 years of relevant experience in asset management and reliability engineering.
3. Experience working in any of the various CMMS’ currently available (preferably in SAP, Maximo, or BMRAM).
4. Ability to read and interpret SOP (Standard Operating Procedures), engineering drawings and system specifications is required.
5. Understanding of General Utilities systems (CO2, RO, WFI, N2, etc.)
6. Familiarity with ISO 55000 standards is a plus.
7. Experience in cGMP or other regulated industry.
8. Strong analytical skills and proficiency in data analysis tools.
9. Excellent communication skills, both verbal and written.
BRIEF DESCRIPTION:
The Validation Specialist performs installation, operational, and performance qualification (IQ/OQ/PQ) of critical manufacturing equipment, Laboratory Instruments, Laboratory systems, facilities, and utility systems. Will complete temperature mapping for facility and systems. The Validation Engineer provides technical support for process manufacturing and packaging equipment, including investigations and correction of deviations from standards.
JOB RESPONSIBILITIES:
1. Generate and Performs installation, operational, and performance qualification (IQ/OQ/PQ) of critical manufacturing equipment, facilities, and utility systems. Responsibilities include newly installed equipment and systems, as well as previously qualified equipment and systems which are modified through Change Control, and periodic assessments of equipment, facilities, and utility systems.
2. Performs temperature mapping activities for facility and equipment.
3. Develops and reviews qualification protocols and reports, coordinates system and equipment documentation collection, and execution of protocols.
4. Solves qualification execution issues using critical analysis skills, and develops sound, reasoned solutions and recommendations.
5. Works with Operating Technicians and Maintenance during fieldwork and execution of protocols.
6. Oversees capital qualification services related to processing and/or packaging, and performs peer review of contract/consulting documentation.
7. Performs fieldwork such as checking systems and equipment that are located in manufacturing areas, on mezzanines and rooftops, and in mechanical spaces or penthouses.
8. Represents the Validation group in Change Control Committee meetings and in departmental qualifications and cleaning validation discussions.
9. Verifies red-line drawings to “as-built” status.
10. Performs assessments to determine if re-qualification and/or re-validation is needed, in accordance with local procedures.
11. Participates in the validation activities associated with all Quality Investigations.
12. Supports the Site Validation Master Plan and Master Schedule including all aspects of design qualification, verification, installation qualification, operational qualification, performance qualification, process validation, and cleaning validation for processing, packaging, equipment, computer systems, critical utilities, and equipment cleaning.
13. Achieves effective financial control through management of validation scopes, estimating, effective use of financial and budgeting tools, risk management, and proper project close-outs.
QUALIFICATIONS:
1. Bachelor’s degree in the Life Sciences required; preferably in Engineering, Chemistry, Biology, or Pharmaceutical Sciences.
2. 3-5 years of relevant validation experience in a GMP industries, working in pharmaceutical and biotech manufacturing facilities. A combination of education and relevant experience will be considered.
3. Experience in the Bio-pharmaceutical industry and related regulatory, engineering, and construction techniques is highly desirable.
4. Knowledge and understanding of validation and qualification principles, project management, and change control principles.
5. A solid base and application experience in pharmaceutical manufacturing plants and/or research facilities, and/or related environmental projects, material handling, containment, and utility/infrastructure support facilities.
6. Demonstrated ability to effectively communicate and collaborate at a variety of levels with customers, vendors, equipment suppliers, and operations staff.
7. Experience performing IQ/OQ/PQ is preferred.
8. Experience using K2000 Validator and other temperature mapping equipment.
BRIEF DESCRIPTION:
The Project Manager is a contractor position responsible for developing and executing project/program plans for the organization, dedicated to drive deliverables and other critical initiatives related to the project. The Project manager coordinates cross-functional efforts, ensuring comprehensive planning and optimal execution of plans, this includes planning, executing, and finalizing projects according to established scope, timeline and budget criteria, identify and respond to critical path barriers, maintain a risk registry and associated contingency plans, mitigation, resolution and escalation of issues, and prepare executive progress reports. Supports project/programs and teams with passion, innovation, speed and accountability.
JOB RESPONSIBILITIES:
1. Drives delivery of detailed plans, critical path activities and timing while achieving key milestones in alignment with program goals and benefits with the goals of the organization.
2. Manage and lead cross-functional project and/or program teams.
3. Ensure benefits, scope, goals, assumptions and deliverables are well defined and understood by the team and stakeholders.
4. Manages project activities including recurring status meetings, reporting, tracks risks, actions and addresses risks and issues by documenting, communicating or escalating to appropriate governance.
5. Drives the development of full scale plans and timelines and cost and resources estimates with input from all required departments
6. Lead team meetings and ensure that meeting agendas and minutes are issued in a timely manner.
7. Ensure that communications between teams, functional management, senior management and executive leadership are handled in an efficient, effective and timely fashion. Develop executive status reports.
8. Support change management strategy and plan.
9. Proactively manage changes in scope, identify potential issues and devise contingency plans, escalate potential impact on plans and timelines, and ensure execution to closure.
10. Foster high performance teamwork and maintain strong relationships with stakeholders.
11. Responsible for capture and communication of key learnings between existing and future project teams taking advantage of available knowledge management tools.
QUALIFICATION AND REQUIREMENTS:
1. B.S. or B.A. in Engineering, Pharmacy, supply chain, sciences or technical disciplines, or allied business function.
2. Familiarity with BioPharma or life sciences industry and CGMP practices
3. 5 years of business experience, 3 years in life sciences preferable with Quality Labs construction and/or renovation related projects. 3 years of experience managing capital construction projects
4. PMP or similar professional certification highly desirable.
5. Lean sigma knowledge and expertise is highly desirable
6. Proficiency with project management and Microsoft tools, e.g. Microsoft Project, Primavera P6, Excel, PowerPoint, SharePoint.
7. Advanced critical reasoning, negotiation, problem solving and decision-making skills
8. Advanced written and verbal communication skills, must be able to interact and communicate effectively at all levels of the organization
9. Strong organizational skills and ability to work independently with high level of accountability.
10. Ability to work in a highly matrixed environment.
11. High organization skills with ability to multi-task several objectives in parallel
12. People and project management skills
BRIEF DESCRIPTION:
The Process Engineer supports manufacturing operations with scientific expertise to ensure the successful transfer of new products from development to manufacturing ensuring robust manufacturing processes at commercialization, failure investigation of commercialized products, and support processes to ensure performance within expected parameters. Includes laboratory roles.
JOB RESPONSIBILITIES:
1. Monitor and improve Manufacturing KPI – Overall Equipment Efficiency, Throughput, and Unplanned Stops during shift operation by supporting daily execution of Standard Works – Centerlines, Cleaning, Inspection, Start-ups and Shutdowns, and Changeovers
2. Supports problem solving using continuous improvement tools – RCAs, fishbone, and 5S
3. Assists in the development of technical and operating standards – Standard Operating Procedures, One Point Lessons, Job-Aides, and Troubleshooting Guides and training of manufacturing Associates
4. Co-creates validation documents (IQ, OQ, & PQ) and leads the execution of process qualifications for new and existing production systems
5. Follows and observes all regulatory requirements (GMPs, ISO, FDA, OSHA, internal policies) applicable to the area of responsibility
QUALIFICATION AND REQUIREMENTS:
1. Bachelor’s degree in Engineering or a related discipline; or equivalent combination of education and experience to perform at this level. A minimum of 2+ years overall related engineering experience within the medical device or a regulated industry
2. Ability to work off-shift
3. Professional Certification – Lean Six Sigma Green Belt or on track to getting certified within 12 months of hire
4. Proficient with Manufacturing software – Minitab and Microsoft Applications – MS-Visio, MS-Power BI, MS-Excel, MS-Word, MS-PowerPoint
5. Familiarity with cGMP, ISO, and FDA regulations
BRIEF DESCRIPTION:
The CSV Specialist performs installation, operational, and performance qualification (IQ/OQ/PQ) of critical manufacturing equipment, Laboratory Instruments, Laboratory systems, facilities, and utility systems. Will complete temperature mapping for facility and systems. The Validation Engineer provides technical support for process manufacturing and packaging equipment, including investigations and correction of deviations from standards.
JOB RESPONSIBILITIES:
1. Generate and Performs CSV protocols to function with the (IQ/OQ/PQ) of critical manufacturing equipment, facilities, and utility systems. Responsibilities include newly installed equipment and systems, as well as previously qualified equipment and systems which are modified through Change Control, and periodic assessments of equipment, facilities, and utility systems.
2. Performs temperature mapping activities for facility and equipment
3. Develops and reviews qualification protocols and reports, coordinates system and equipment documentation collection, and execution of protocols.
4. Review of Part 11 Compliance for all systems in the facility, Computer System validations Assessment
5. Draft Data Integrity protocol and execution plans for manufacturing equipment and Lab systems
6. Solves qualification execution issues using critical analysis skills, and develops sound, reasoned solutions and recommendations.
7. Works with Operating Technicians and Maintenance during fieldwork and execution of protocols.
8. Oversees capital qualification services related to processing and/or packaging, and performs peer review of contract/consulting documentation.
9. Performs fieldwork such as checking systems and equipment that are located in manufacturing areas, on mezzanines and rooftops, and in mechanical spaces or penthouses.
10. Represents the Validation group in Change Control Committee meetings and in departmental qualifications and cleaning validation discussions.
11. Performs assessments to determine if re-qualification and/or re-validation is needed, in accordance with local procedures.
12. Participates in the validation activities associated with all Quality Investigations.
13. Supports the Site Validation Master Plan and Master Schedule including all aspects of design qualification, verification, installation qualification, operational qualification, performance qualification, process validation, and cleaning validation for processing, packaging, equipment, computer systems, critical utilities.
QUALIFICATION AND REQUIREMENTS:
1. Bachelor’s degree in the Life Sciences required; preferably in Engineering, Chemistry, Biology, or Pharmaceutical Sciences.
2. 3-5 years of relevant validation experience in a GMP industries, working in pharmaceutical and biotech manufacturing facilities. A combination of education and relevant experience will be considered.
3. Experience in the Bio-pharmaceutical industry and related regulatory, engineering, and construction techniques is highly desirable.
4. Knowledge and understanding of validation and qualification principles, and change control principles.
5. A solid base and application experience in pharmaceutical manufacturing plants and/or research facilities, and/or related environmental projects, material handling, containment, and utility/infrastructure support facilities.
6. Demonstrated ability to effectively communicate and collaborate at a variety of levels with customers, vendors, equipment suppliers, and operations staff.
7. Experience performing Data Integrity assessments is preferred.
8. Experience using K2000 Validator and other temperature mapping equipment.