Careers

The Senior Validation Scientist must have the ability to work in a highly matrixed and cross-functional organization, against tight deadlines, and with world-class partners, suppliers and business leaders alike. It will be responsible for developing and executing control systems or related infrastructure compliance documentation, while remaining aligned with the company’s and client’s strategy, commitments and goals.

Job Description:

The Senior Validation Scientist will provide support to the commissioning and qualification (C&Q) activities. The successful candidate must have C&Q / Validation experience in regulated environment industries such as pharmaceutical, bio-pharmaceutical or medical devices companies. It will be responsible of generates, executes, reviews, and complete qualification and validation documentation, summary reports and associated data for conformance to regulations, SOPs, specifications and other applicable acceptance criteria.

General Scope and Requirements

• Conducts temperature/relative humidity mapping qualification studies (Warehouse, Controlled Room Temperature, Walk-In Freezer and Cold Room) to ensure that a system functions as to routinely produce results that meet predetermined specifications.
• Conducts facilities, critical utilities (high quality of water, steam and compressed gases) and equipment (HVAC) qualification exercises to ensure that the systems meet predetermined specifications.
• Hands on experience in the use/troubleshooting of validation equipment such as temperature/relative humidity data loggers.

Qualifications:

• Minimum 3 years of C&Q | validation in Biotech | Pharmaceutical, Medical Device or in a related area.
• Fully Bilingual (English & Spanish) (Required)
• Experience in writing and executing qualification protocols (i.e. Temperature Mapping Characterization Study, Commissioning, IQ, OQ, and Report).
• A solid understanding of FDA Validation guidelines
• Proficient in CTCs thermal mapping studies and strong knowledge of temperature mapping equipment and software (e.g. Data Loggers)
• GMP and regulatory experience with expertise in equipment qualification.
• Experience with Technical Document, such as: requirement specification, validation plan, protocols, traceability matrices and summary reports (Preferred).
• Microsoft Office Suite – Word, Excel, PowerPoint, and Outlook

Education:

• Bachelor’s degree in Science/Engineering or related field

Job Types: Contract, Full-time

Job Description:

The Change Control Project Coordinator must be able to demonstrate the understanding of the change, the importance of the change level classification and impact on validation processes, the resources needed to adequately assess the change impact(s), support the change activities, and components of a well-written change scope summary and justification.

General Scope:

• Responsible to ensure that the change is complete, compliant with established process requirements, and managed timely throughout lifecycle

• Change is initiated in the system
• Execution
• Closing

• Identify, engage and collaborate with Quality Contact and SMEs to understand impact, risks and controls required during the change development phase.
• Schedules and coordinates information gathering sessions for change development, ensuring the record is clear and accurate
• Confirms change strategy and required actions in conjunction with the Quality Contact and SME’s.
• Manages the execution of the change (documentation, task management, evidence of completion, effectiveness verification, non-standard work, etc.)
• Proficient using Change Control Management applications (e.g: Experience working with TrackWise)
• Responsible for the compliance review and approval of validation protocols, plans and reports for analytical and equipment qualification.
• Support the deliverables of the assessments with the functional areas.
• Strong knowledge (according to related area) of Equipment Qualification and Computer System Validation.

Roles/Responsibilities:

• Participate during project weekly meetings.

• Comply with project schedule and escalate any roadblock or issues immediately including proposed mitigation plan.

Education:

• Bachelor’s degree in Science/Engineering or related field.

Job Types: Contract, Full-time

The Validation Specialist must have the ability to work in a highly matrixed and cross-functional organization, against tight deadlines, and with world-class partners, suppliers and business leaders alike. It will be responsible for developing and executing control systems or related infrastructure compliance documentation, while remaining aligned with the company’s and client’s strategy, commitments and goals.

General Scope and Requirements:

• Minimum 2 years of experience performing C&Q and/or validation activities.
• Minimum 2 years of experience in Pharma-Bio and Medical Device industry.
• Experience with benchtop laboratory (COTS) equipment qualification and/or process validation.

 

• Knowledge in computer system validation (CSV) for Laboratory Equipment Systems is a plus.

 

• Generate and execute validation deliverables

 

• Documentation includes but is not limited to validation plan/strategy, 21 CFR Part 11 compliance, Data Integrity Assessment documentation, IQ/OQ testing protocols, SOP(s) revision, deviations and reporting.

• Use of validation equipment and instrumentation
• Technical writing skills
• Temperature chambers knowledge (operation, validation, maintenance)
• MS Office suite
• Complete appropriate cGMP documentation throughout validation life-cycle
• Excellent organization and communication skills

Roles/Responsibilities:

• Participate during project weekly meetings.
• Comply with project schedule and escalate any roadblock or issues immediately including proposed mitigation plan.

Education:

• Bachelor’s degree in Science/Engineering or related field.
• Fully Bilingual (English & Spanish) is required.

Job Types: Contract, Full-time

Job Description:

The Project Manager will manage projects by analyzing information, developing and tracking project plans, providing expertise to resolve project difficulties and directing resources.

General Scope and Requirements

• Assist in the management of the enterprise project portfolio within the scope of the Project Management Office
• Present outcome of feasibility assessment and project plans to executive leadership team to ensure alignment on project scope, timeline and deliverables
• Assist in the management, planning and tracking of activities for multiple project teams across products, functions and sites. Develop schedules and performance requirements. Responsible for ensuring project goals are met on time.
• Interact frequently with outside partners, project team members and senior staff to ensure cooperation and achievement of common goals.
• Analyze company goals in relation to project tasks in order to balance new and existing projects. Facilitate project and product development teams by:

• Determining project team composition and preparing organizational charts
• Evaluating appropriate sources for project information and dissemination of information as appropriate to relevant employees and outside partners.
• Analyzing resources and priorities to be applied to assigned projects.
• Analyzing information in order to prepare and update project plan timelines.
• Assessing project activity; identifying and resolving potential project complications.
• Facilitating problem solving and consensus building.

• Assist in the management of the enterprise project portfolio within the scope of the Project Management Office
• Identify and implement best practices in order to facilitate standardization and coordination across disciplines, functions and/or programs.
• Present technical information to senior staff concerning specific projects, schedules, budgets, etc.
• Inform management of progress and potential challenges in a timely manner.
• Educate project team members across all functions on how to actively and efficiently contribute in projects.

 Qualifications:

• Minimum 5 years of PM | Biotech | Pharmaceutical, Medical Device or in a related area.
• Fully Bilingual (English & Spanish) (Required)
• Proficiency with project management tools such as Monday.com, Wrike, Basecamp or Asana
• Collect, analyze, and interpret data to identify trends, patterns and insights; assist teams in researching, understanding, acquiring, and properly using data sets
• Collaborate with cross-functional partners to understand data sets and provide data-driven recommendations; conduct ad-hoc data analysis and provide insights to answer specific business questions
• Perform statistical analysis and data minding to uncover actionable insights
• Present findings and visualizations to executive leadership team in a clear and concise manner
• Microsoft Office Suite – Word, Excel, PowerPoint, and Outlook

Education:

• Bachelor’s degree in Science, engineering or business is required
• CAPM, PMP or Six Sigma Certification preferred

Job Types: Contract, Full-time

Job Description:

The Quality Assurance Manager will be responsible for all quality personnel functions including hiring, assignment and direction of work, development and training, disciplinary actions and termination, and the maintenance of all quality personnel records.

General Scope and Requirements

• Ensure the laboratory team follows all applicable company policies and procedures
• Oversee daily actions that facilitate product collection (sample collection and submission; testing results, staging).
• Assist the Quality Assurance Unit ensuring donor center records are complete and accurate.
• Ensure shipments (sample, product, waste, etc.) are managed and labeled accurately.
• The interpretation and application of SOPs; and, ensuring SOP revisions are implemented correctly, efficiently and effectively.
• The receipt, approval and release of donor center supplies.
• Assist Center Management and Training Coordinator to ensure training is conducted and documented as directed, review and prepare for inspections/audits, and to develop CAPA, and other quality duties as assigned.
• Oversee and manage the center’s Deviation Management System to ensure adequate investigations are completed, accurate root cause(s) identified, and CAPA process is identified and managed.
• Track and trend the center’s quality and operational metrics with respect to applicable SOPs.
• Perform periodic self-assessments of the center’s quality and compliance.
• Administratively oversee the performance and submission of the center’s Proficiency Testing process (Note: this does not replace any CLIA regulated process)
• Manage the document control process of the center and suggest necessary SOP changes as required.
• Supervise the center’s Quality Assurance Unit employees.
• Work effectively and partner with the Field Quality, Operations support, Center Director and Corporate staff to ensure daily operations are in full compliance.
• Maintain an open line of communication with Management.
• Responsible for working through multiple projects and managing multiple competing priorities.

Qualifications:

• Minimum 7 years of C&Q | validation in Biotech | Pharmaceutical, Medical Device or in a related area.
• Fully Bilingual (English & Spanish) (Required)
• Demonstrated ability to define problems, collect data, establish facts and draw valid conclusions
• Ability to interpret a wide variety of technical instructions in mathematical or diagram form and deal with several abstract and concrete variables
• Ability to read and interpret documents such as safety rules, operating and maintenance instruction, and procedure and technical manuals
• Must be fully signed off and capable of performing duties of the Manager of Quality Assurance
• Ability to work independently with little supervision
• Demonstrated ability to define problems, collect data, establish facts and draw valid conclusions
• Must have explicit attention to detail
• A solid understanding of FDA Validation guidelines
• Experience with Technical Document, such as: requirement specification, validation plan, protocols, traceability matrices and summary reports (Preferred).
• Microsoft Office Suite – Word, Excel, PowerPoint, and Outlook

Education:

• Bachelor’s degree in Science or technical field

Job Types: Contract, Full-time