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CQV Consultant IV, Drug Product

Pennington, NJ 08534

Posted: 02/07/2024 Employment Type: Contract Job Category: Engineering Job Number: 598889 Is job remote?: No Country: United States

Job Description



Responsible for providing quality oversight for the qualification and validation activities for equipment, utilities, and facilities. This role will be responsible for drafting, reviewing and approving qualification protocols/reports and any associated documentation in support of CQV activities for a new facility. The Role also need to drive the validation activity close out.

 

Essential Functions of the job:
  • A solid understanding of FDA Validation guidelines GMP and regulatory experience with expertise in process validations
  • Experience in writing and executing validation protocols (i.e. DQ, IQ, OQ, PQ) Knowledge of specific manufacturing equipment
  • Complete appropriate cGMP documentation throughout validation life-cycle
  • Executes qualification and validation in compliance to regulatory requirements by/with/as carry out qualification and validation according to the Validation Program Use test equipment, instruments and methods to produce data for validation.
  • Perform data analysis using statistical methods as appropriate to produce conclusions and recommendations for relevant work activities.
  • Document root cause and corrective/preventive actions of gap found during validation activities Work under minimal supervision.
  • Relies on experience and judgement to plan and accomplish assigned goals.
  • May periodically assist in orienting, training, assigning and checking the work of lower level employees Judgement is required in resolving complex problems based on experience
  • Supports Project Teams in: GMP Impact Assessments, Instrument Criticality Lists, Critical Components Lists, Requirements Traceability matrices, Design Qualification, Vendor documentation checklists, final handover of documents to Operations Assisting in troubleshooting of process issues, process characterization and root cause investigations Involved in resolving deviations / non-conformances observed during execution of qualification and validation activities.
  • Ability to prepare / issue change controls, CAPAs, and investigations.
  • Ability to maintain gowning requirements as needed to access controlled areas Demonstrated deep technical skills in aseptic manufacturing/process.
  • Equipment:
  • Assist in development, review, and approval of cGMP documents including, but not limited to: Master Validation Plans, FAT/SAT documents, Turnover Packages, SOP’s, specifications, traceability matrices, thermal mapping documents, and design documentation.
  • Provide expertise and solutions to issues regarding CQV Lifecycle documentation in regards for applicable FDA/EMEA Regulations
  • Support validation activities for project activities including review of validation documentation (FAT, SAT, URS, SDS, IQ, OQ, PQ) and attendance at validation activities.
  • Provide support to enforce CQV guidelines, policies and procedures for equipment, analytical equipment, utilities, and facilities (Examples: Bioreactor, Incubator Chromatography Systems, harvest hold tank, washers, autoclaves, etc.)
  • Employee will be required to work closely with Manufacturing, Validation, Site Automation, Engineer, Quality Control, and Global Technical Operations (GTS) associates.
  • Ensuring appropriate investigation of validation discrepancies, errors, protocol failures, or validation testing errors requiring documented review and action to reconcile deviations.
  • Undertaking any other duties for any department within the business, which may be requested by the Manager, for which training and/or an explanation has been provided and understood.

Required Core skills

Filling Line equipment and Process includes and is not limited to:
  • Smoke study supporting process and equipment validation.
  • EMPQ
  • Experienced with Grade A Isolator and filling module.
  • Process knowledge with Isolator decontamination cycle
  • Stopper /Capper sterilization equipment
  • Capper Module
  • Auto-Inspection process knowledge
  • Packaging Line equipment knowledge
  • Formulation Suite  contains Single Use Mixers, Weigh Scales and Filter Integrity Testers., Incubators, Cold room
  • SCADA, DCS, EMS automation knowledge
  • Scientific degree (ideally: pharmaceutical sciences, engineering, chemistry, or related discipline).
  • Minimum of 7-10 years’ experience in validation, biological quality assurance and/or quality control in an FDA-regulated biotechnology or pharmaceutical company with progressive levels of responsibility.
  • 1-3 years in a quality assurance or quality control role in an FDA-regulated company
  • Strong knowledge of cGMP’s 21CFR parts 2010 & 211, knowledge of 21CFR600 – Biologics desirable.
  • Demonstrated knowledge of ISPE Baseline Guide 5, ASTM E-2500, EU regulatory requirements, and GAMP 5 Validation Lifecycle.
  • Knowledgeable in risk assessments and process for following well documented and thought through risk-based approaches.
  • Demonstrable track record and skills/experience gained within a similar position(s), at a similar level.
  • Good collaboration and good project management skills.
  • Credible and confident communicator (written and verbal) at all levels.
  • Customer focused, Strong analytical and problem-solving ability.
  • Hands-on approach, with a ‘can do’ attitude. Able to work under minimal supervisor.
  • Ability to prioritize, demonstrating good time management skills.
  • Excellent attention to detail, with the ability to work accurately in a busy and demanding environment.
  • Self-motivated, with the ability to work proactively using own initiative.
  • Committed to learning and development.
  • Highly Desirable: Good IT skills e.g., Microsoft Office (Word, Excel, PowerPoint, Project and Outlook).

Significant Contacts

Manufacturing, Validation, Site Automation, Engineer, Quality Control, and Global Technical Operations (GTS) associates.

Supervisory Responsibilities:

Individual Contributor, no direct reports that works as part of the QA Validation team - may manage 

Competencies:
Ethics - Treats people with respect; Inspires the trust of others; Works with integrity and ethically; Upholds organizational values.

Planning/Organizing - Prioritizes and plans work activities; Uses time efficiently. Completes administrative tasks correctly and on time. Follows instructions and responds to management direction.

Communication - Listens and gets clarification; Responds well to questions; Speaks clearly and persuasively in positive or negative situations. Writes clearly and informatively. Able to read and interpret written information.

Teamwork - Balances team and individual responsibilities; Gives and welcomes feedback; Contributes to building a positive team spirit; Puts success of team above own interests; Supports everyone's efforts to succeed.
Contributes to building a positive team spirit; Shares expertise with others.

Adaptability – Able to adapt to changes in the work environment. Manages competing demands. Changes approach or method to best fit the situation. Able to deal with frequent change, delays, or unexpected events.

Technical Skills - Assesses own strengths and development areas; Pursues training and opportunities for growth; Strives to continuously build knowledge and skills; Shares expertise with others.

Dependability - Follows instructions, responds to management direction; Takes responsibility for own actions; Keeps commitments; Commits to long hours of work when necessary to reach goals; Completes tasks on time or notifies appropriate person with an alternate plan.

Quality - Demonstrates accuracy and thoroughness; Looks for ways to improve and promote quality; Applies feedback to improve performance; Monitors own work to ensure quality.

Analytical - Synthesizes complex or diverse information; Collects and researches data; Uses intuition and experience to complement data.

Problem Solving - Identifies and resolves problems in a timely manner; Gathers and analyzes information skillfully.
Project Management - Communicates changes and progress; Completes projects on time and budget.
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