Validation Engineer/Manager - Biotech - Rhode Island

Company: Michael Page
Location: Providence
Posted on: March 12, 2023

Job Description:

Responsible for the delivery of the qualification programs, ensuring equipment and systems are qualified and in an operational state of compliance associated with cGMP manufacturing environments. Work closely with Engineering / Facilities, Equipment End Users and Quality Assurance to investigate and resolve non-conformances encountered during qualification activities.Client DetailsOur client is a Privately Held small company developing novel therapeutics for degenerative eye diseases. Their cutting edge therapeutic can help patients with serious diseases that would go untreated otherwise. With products in early and late stage clinical development, this client has a strong pipeline of therapies now and into the future. With amazing data returns from their Phase III study in late 2022, they are pursuing commercialization in the next 12 - 18 months. Description

• Provide guidance / supervision on company's internal validation programs as well as managing external validation service providers.
• Excellent technical documentation generation and review skills ensuring the content is technically sound, adheres to applicable site procedures and is suitable for regulatory submission / inspection.
• Assists in development of validation standards and templates.
• Provide validation subject matter expertise / support for equipment and systems in use at company's facility.
• Track and report status on metrics relevant to the operations qualification programs activities / responsibilities and ensure commitment to key stakeholders are met.
• Ensure the validated status of site facilities, utilities, equipment is established in accordance with internal procedures, regulatory requirements, and industry guidance / standards.
• Define and execute the validation strategy associated with operations, covering a range of facilities, utilities, equipment, and processes in accordance with manufacturing timelines.
• Maintain an awareness of regulatory and industry best practice trends.
• Drive results on multiple complex assignments simultaneously with minimal required direction from his / her manager.Profile
  • B.S. with 3-5 years and M.S. with 1-3 years for Engineer level
  • B.S. with 8+ years and M.S. with 5+ years for Manager level
  • Proven experience leading validation teams.
  • Strong understanding of validation principles including but not limited to facilities, utilities, equipment, and systems (FUSE).
  • Technical writing skills required.
  • Experience in medical device and biotechnology field.
  • Ability to manage personnel and expectations and deliver on timely requirements.
  • Extensive knowledge of GMP, strong understanding of FDA/ICH regulations and Quality Systems
  • Solid background in Quality Assurance/Systems including interpreting regulations, guidelines, and identification of compliance issues.
  • Experience in drafting audit reports and developing gap assessments
  • Excellent communication skills, verbal and written.
  • Excellent interpersonal and communication skills (verbal and written) are required.
  • Proficiency in using Microsoft Office applications required (MS Word, MS Excel, MS PowerPoint)
  • Ability to interact well with other groups and must be able to take ownership of and follow through on assignments.
  • Ability to work both independently with direction and within project teams to attain goals.
  • Ability to build consensus among colleagues with an appropriate level of flexibility, while maintaining a focus on results and goal attainment.Job Offer
    • Highly competitive base salary
    • Growth opportunity- extensive opportunity for promotions and a larger role
    • Fast paced position supporting multiple functions
    • Great benefits package
    • Extremely fast-paced, growing environment
    • Company in late stage Phase III and approaching commercialization
    • Strong ownership funding with passion for treating degenerative eye disease MPI does not discriminate on the basis of race, color, religion, sex, sexual orientation, gender identity or expression, national origin, age, disability, veteran status, marital status, or based on an individual's status in any group or class protected by applicable federal, state or local law. MPI encourages applications from minorities, women, the disabled, protected veterans and all other qualified applicants.

Keywords: Michael Page, Providence , Validation Engineer/Manager - Biotech - Rhode Island, Engineering , Providence, Rhode Island