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Validation Engineer - III (Senior) : Durham, NC

Company:
Lancesoft Inc
Location:
Durham, North Carolina, 27712, United States
Posted:
December 02, 2016
Description:

Job Description:

Qualifications Required:

o 5 or more years cleaning validation experience in GMP Pharmaceutical manufacturing environment

o Experience preparing/authoring technical documentation / validation protocols.

o Effective communication - both verbal and written

o Demonstrated collaboration and teamwork skills

o Demonstrated independent project management skills

o Passing medical surveillance test results for Tice®BCG

Preferred:

o B.S. (or equivalent 4-year degree) in Biology, Engineering or Science

o Previous experience with biologics and/or vaccines

o Previous experience with washers (parts/equipment, bead, and/or glass vial)

o Previous experience with manual and ultra-sonic cleaning methods.

Scope:

The scope of activities is not limited to: equipment cleaning validation/qualification activities (IQ, OQ, PQ) associated with the following processes:

• Stainless Steel Bead Washer

• Pass-Through Parts Washer

• Double-Door Lyophilization Chamber – Manual Cleaning

• Ultra Sonic Cleaner (small parts) The successful candidate must be a self-starter, with strong analytical problem solving skills, independent project management experience, with well-established technical writing skills. The successful candidate should be able to examine issues from diverse perspectives (safety, compliance, automation, equipment, process, and people) in order to prepare, field-verify, approve, execute, and summarize cleaning validation protocols.

Primary Activities:

1. Author technical cleaning validation documents such as protocols, feasibility studies, and deviation investigations that align with corporate standards and industry requirements.

2. Adhere to Change Control procedures and ensure processes are maintained in a validated state through recertification / re-validation activities.

3. Provide technical and/or investigational support in troubleshooting and resolving manufacturing process issues.

4. Partner (collaborate) with other internal departments (Operations, Quality, Plant Engineering, and Technology), and external centers of excellence (COEs) on cleaning validation related activities/events (e.g. laboratory testing)