Validation Engineer/Manager - Biotech - Rhode Island
Company: Michael Page
Posted on: March 12, 2023
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
- Excellent technical documentation generation and review skills
ensuring the content is technically sound, adheres to applicable
site procedures and is suitable for regulatory submission /
- Assists in development of validation standards and
- 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
- 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
- B.S. with 8+ years and M.S. with 5+ years for Manager
- Proven experience leading validation teams.
- Strong understanding of validation principles including but not
limited to facilities, utilities, equipment, and systems
- Technical writing skills required.
- Experience in medical device and biotechnology field.
- Ability to manage personnel and expectations and deliver on
- 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
- Experience in drafting audit reports and developing gap
- 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
- Highly competitive base salary
- Growth opportunity- extensive opportunity for promotions and a
- Fast paced position supporting multiple functions
- Great benefits package
- Extremely fast-paced, growing environment
- Company in late stage Phase III and approaching
- 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
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