PolyPeptide Laboratories Group - One of the world’s largest companies that specializes in the manufacturing of peptide and related compounds for research and pharmaceutical applications.
More information is available at our website www.polypeptide.com
Job Title: Validation Engineer/Specialist
Job Overview: As part of the Technical Services and Facilities team, the Validation Engineer/Specialist will be responsible for validation (Process equipment cleaning) activities by constant communication with concerned departments and personnel. This position will be based in Torrance, California.
Essential Job Responsibilities:
- Support the process development efforts to develop and scale-up the manufacturing process for active pharmaceutical ingredients.
- Work to establish justification and documentation for critical process parameters for process validation.
- Perform cleaning verification and validation of production equipment.
- This position will involve working closely as a team with process development, manufacturing and quality groups using principles of concurrent engineering to ensure manufacturability of the process.
- Support equipment specification development and acquisition; develop and implement plans for IQ, OQ and PQ of the equipment.
- Assist the manufacturing operations in problem solving as it relates to equipment and systems.
- Generate documentation (SOPs, reports, protocols, etc.) to support the manufacturing operations as needed.
- Provide support to the in-house manufacturing group and/or other PPL sites to scale-up and transfer manufacturing processes.
Required Skills/Qualifications:
- An undergraduate degree in Chemical Engineering or applicable science based degree required.
- 6-8 years of professional experience as a Validation Engineer/Specialist in a Pharmaceutical/Biotech industry.
- Excellent interpersonal skills to allow effective participation in project teams.
- Excellent oral and written communication skills.
- Knowledge of process and cleaning validation is a must using risk based methodology. Experienced with establishing critical parameters and justifying the process validation. Must be able to lead DOE protocol/report generation and work with the process development during the experimentation.
- Good understanding of Good Manufacturing Practices (cGMP).
- Experience with bulk API and/or peptide processes is a plus.
Qualified applicants may send resume with salary history and requirements to HR_resume@pplusa.com. Must indicate reference job code VE/S-PPL when applying.
PolyPeptide Laboratories, Inc.