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DS Manufacturing Engineer III (CQV)

Hopewell, NJ 08534

Posted: 02/07/2024 Employment Type: Contract Job Category: Engineering Job Number: 596794 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:
  • 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.
Core Competencies, Knowledge, and Skill Requirements
  • Bachelor or above of Science Degree in a related scientific discipline
  • Scientific degree (ideally: pharmaceutical sciences, engineering, chemistry, or related discipline).
  • Minimum of 5 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).Manufacturing, Validation, Site Automation, Engineer, Quality Control, and Global Technical Operations (GTS) associates.

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.

Computer Skills:
  • Strong PC literacy required; MSOffice skills (Outlook, Word, Excel, PowerPoint); knowledge of SAP QM module

Other Qualifications:

  No

Travel:
  • Must be willing to travel approximately 5-10%; requires a valid passport.

Ability to work on a computer for extended periods of time
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