Integrated Services For Productivity & Validation, Inc

Experience in handling deviations/non-conformances investigations.Skills for technical writing and development of reports.Knowledge and experience with root cause analysis tools (e.g. causal factors analysis 5 Whys).Project management skills on identifying/tracking actions and achievi

Experience in handling deviations/non-conformances investigations.Skills for technical writing and development of reports.Knowledge and experience with root cause analysis tools (e.g. causal factors analysis 5 Whys).Project management skills on identifying/tracking actions and achievi

Extensive experience in process development or manufacturing support within biotech biopharma or related industries. Strong ability to analyze and interpret complex process and experimental data to drive process understanding and optimization. Experience supporting process scale-up t

Extensive experience in process development or manufacturing support within biotech biopharma or related industries. Strong ability to analyze and interpret complex process and experimental data to drive process understanding and optimization. Experience supporting process scale-up t

Excellent written and verbal communication skills Technical writing experience Working knowledge and experience with cGMP procedures and engineering practices on pharmaceutical/biotech production processes facilities and equipment. Experience with QRAES Change cControl non conformanc

Excellent written and verbal communication skills Technical writing experience Working knowledge and experience with cGMP procedures and engineering practices on pharmaceutical/biotech production processes facilities and equipment. Experience with QRAES Change cControl non conformanc

Experience or knowledge in Fermentation Cell Culture or Harvest process is preferred. Also experience supporting commercial campaigns is preferred. Fermentation Cell Culture HarvestRequirementsMasters degree OR Bachelors degree in Engineering & 2 years of Engineering ex

Experience or knowledge in Fermentation Cell Culture or Harvest process is preferred. Also experience supporting commercial campaigns is preferred. Fermentation Cell Culture HarvestRequirementsMasters degree OR Bachelors degree in Engineering & 2 years of Engineering ex

Deviations documentation and Change Control Management.RequirementsDoctorate OR Masters 2 years of Manufacturing Operations experience Alternatively Bachelors 4 years of Manufacturing Operations experience Alternatively Associates 8 years of Manufacturing Operations experience Alte

Deviations documentation and Change Control Management.RequirementsDoctorate OR Masters 2 years of Manufacturing Operations experience Alternatively Bachelors 4 years of Manufacturing Operations experience Alternatively Associates 8 years of Manufacturing Operations experience Alte

1. C&Q Strategy & Planning Develop and implement the overall Commissioning & Qualification strategy aligned with project and regulatory requirements. Define system boundaries and identify direct/indirect impact systems. Lead risk assessments (e.g. ISPE Baseline ASTM E2500) to determin

1. C&Q Strategy & Planning Develop and implement the overall Commissioning & Qualification strategy aligned with project and regulatory requirements. Define system boundaries and identify direct/indirect impact systems. Lead risk assessments (e.g. ISPE Baseline ASTM E2500) to determin

Proficient in creating and executing validation and qualification documentation Provide support to vision inspection qualification and characterizations Requires excellent communication skills with suppliers and other sites A Plus: Knowledge in automated vision inspection systems A P

Proficient in creating and executing validation and qualification documentation Provide support to vision inspection qualification and characterizations Requires excellent communication skills with suppliers and other sites A Plus: Knowledge in automated vision inspection systems A P

Experience in the Manufacturing area specifically writing procedures managing documents in management system (document workflow)RequirementsDoctorate degree OR Masters degree and 3 years of Manufacturing Operations experience Alternatively Bachelors degree and 5 years of Manufacturing

Experience in the Manufacturing area specifically writing procedures managing documents in management system (document workflow)RequirementsDoctorate degree OR Masters degree and 3 years of Manufacturing Operations experience Alternatively Bachelors degree and 5 years of Manufacturing