MassBio Career Center

Validation Manager

Spotlight Preferred
Neurotech Pharmaceuticals
Cumberland, Rhode Island, United States (on-site)
27 days ago

Description

Neurotech Pharmaceuticals is an innovative biopharmaceutical company located in Cumberland, RI, within the realm of Greater Boston’s vast biotechnology landscape. Since our inception more than 20 years ago, we have been developing a proprietary biological drug device combination technology for the treatment of Macular Telangiectasia Type 2 (MacTel). Our Encapsulated Cell Technology (ECT) platform delivers cell gene therapeutic factors for the treatment of this chronic retinal disease.


We are currently seeking to add a Validation Manager who will be 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. This individual will work closely with Engineering / Facilities, Equipment End Users and Quality Assurance to investigate and resolve non-conformances encountered during qualification activities.



Requirements

Job Requirements

  • Provide guidance / supervision on Neurotech’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 Neurotech’s Cumberland, RI 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.


Education & Experience

  • BS in Chemical or Mechanical Engineering. BS degrees in other scientific or health-related fields will be considered.
  • Minimum of 8 years in commissioning / qualification / validation experience in cGMP manufacturing environments.


Knowledge, Skills & Abilities

  • 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.


In addition to a talented and passionate team of colleagues and unparalleled science and technology, Neurotech offers competitive compensation, benefits through Blue Cross BlueShield and HealthEquity (FSA, HAS & HRA), a 401(k) through Fidelity with a company-sponsored match, generous vacation time and company holidays. And that’s just the beginning.


Do you share our vision?


To apply, please send a copy of your résumé to talent@neurotechusa.com.


Neurotech Pharmaceuticals provides equal employment opportunities to all employees and applicants for employment and prohibits discrimination and harassment of any type without regard to race, color, religion, age, sex, national origin, disability status, genetics, protected veteran status, sexual orientation, gender identity or expression, or any other characteristic protected by federal, state or local laws.



Additionally, Neurotech does not accept unsolicited r
ésumés or candidate profiles. If a candidate submitted in this manner is hired, no placement fee will be paid.

Job Information

  • Job ID: 68259641
  • Workplace Type: On-Site
  • Location:
    Cumberland, Rhode Island, United States
  • Company Name For Job: Neurotech Pharmaceuticals
  • Position Title: Validation Manager
  • Job Function: Management
  • Job Type: Full-Time
  • Min Education: BA/BS/Undergraduate
  • Min Experience: 7-10 Years

Please refer to the company's website or job descriptions to learn more about them.

View Full Profile

Jobs You May Like