Pinnaql
Overview
Pinnaql is a trusted consulting partner to regulated life sciences companies, providing deep technical, validation, and quality expertise across every stage of the product lifecycle. We partner with pharmaceutical, biotech, and medical device organizations to navigate complexity, accelerate project timelines, and maintain a strong state of compliance and audit readiness. Validation and Engineering Group, a Pinnaql company, is seeking a
Senior Computer System Validation (CSV) Specialist
with expertise in Manufacturing Execution Systems (MES), specifically Syncade, to support a biologics manufacturing facility. The role will be responsible for planning, authoring, executing, and reviewing validation deliverables in compliance with FDA, EMA, ICH, and GAMP 5 guidelines. The candidate will work closely with Quality, IT, Engineering, and Manufacturing teams to ensure validated, compliant, and reliable MES system operation throughout the system life cycle. Key Responsibilities
Lead and execute CSV activities for MES (Syncade) in a biologics GMP environment. Develop and maintain validation documentation including Validation Plans, User Requirements (URS), Functional Specifications (FS), Design Specifications (DS), Risk Assessments, IQ/OQ/PQ protocols, and summary reports. Partner with Manufacturing and Quality to ensure MES recipes, workflows, and master batch records are validated and compliant. Perform impact assessments and change control for system upgrades, patches, and enhancements. Ensure alignment of CSV deliverables with GAMP 5, 21 CFR Part 11, Annex 11, and other applicable regulations. Collaborate with IT and Engineering teams for system integration (e.g., LIMS, ERP/SAP, DeltaV, PI Historian). Provide audit support during regulatory inspections (FDA, EMA, MHRA, etc.) and customer audits. Mentor junior validation engineers and support knowledge transfer on CSV best practices. Contribute to continuous improvement of MES validation strategies, procedures, and templates. Qualifications
Bachelor's degree in Engineering, Computer Science, Life Sciences, or related field. Advanced degree preferred. 7-10+ years of experience in Computer System Validation within GMP-regulated biologics/pharmaceutical manufacturing. Hands-on expertise with MES Syncade validation and configuration (recipes, workflows, batch records). Strong knowledge of regulatory guidelines: FDA 21 CFR Part 11, EU Annex 11, ICH Q7, GAMP 5. Experience in biologics manufacturing processes (cell culture, purification, fill/finish). Familiarity with integration points (DCS/DeltaV, LIMS, ERP/SAP, data historians). Excellent technical writing and documentation skills. Strong communication, leadership, and problem-solving abilities. Preferred Skills
Experience in large-scale biotech/biologics start-up or tech transfer projects. Knowledge of data integrity principles and ALCOA+ requirements. Exposure to quality management systems (TrackWise, Veeva, ValGenesis, Kneat). Understanding of 21st Century Cures Act and CSA (Computer Software Assurance) approaches. At
Pinnaql , people always come first. We believe that when you\'re empowered to do your best work, bold ideas thrive and real progress happens. This isn\'t just a job; it\'s your opportunity to make a meaningful difference. You\'ll help shape the future of healthcare and technology, working alongside a purpose-driven team that\'s as ambitious as it is supportive. We look forward to hearing from you! Pinnaql
is an equal opportunity employer. All applicants will be considered for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, veteran status, or disability status. #VTLS #ONSITE
#J-18808-Ljbffr
Pinnaql is a trusted consulting partner to regulated life sciences companies, providing deep technical, validation, and quality expertise across every stage of the product lifecycle. We partner with pharmaceutical, biotech, and medical device organizations to navigate complexity, accelerate project timelines, and maintain a strong state of compliance and audit readiness. Validation and Engineering Group, a Pinnaql company, is seeking a
Senior Computer System Validation (CSV) Specialist
with expertise in Manufacturing Execution Systems (MES), specifically Syncade, to support a biologics manufacturing facility. The role will be responsible for planning, authoring, executing, and reviewing validation deliverables in compliance with FDA, EMA, ICH, and GAMP 5 guidelines. The candidate will work closely with Quality, IT, Engineering, and Manufacturing teams to ensure validated, compliant, and reliable MES system operation throughout the system life cycle. Key Responsibilities
Lead and execute CSV activities for MES (Syncade) in a biologics GMP environment. Develop and maintain validation documentation including Validation Plans, User Requirements (URS), Functional Specifications (FS), Design Specifications (DS), Risk Assessments, IQ/OQ/PQ protocols, and summary reports. Partner with Manufacturing and Quality to ensure MES recipes, workflows, and master batch records are validated and compliant. Perform impact assessments and change control for system upgrades, patches, and enhancements. Ensure alignment of CSV deliverables with GAMP 5, 21 CFR Part 11, Annex 11, and other applicable regulations. Collaborate with IT and Engineering teams for system integration (e.g., LIMS, ERP/SAP, DeltaV, PI Historian). Provide audit support during regulatory inspections (FDA, EMA, MHRA, etc.) and customer audits. Mentor junior validation engineers and support knowledge transfer on CSV best practices. Contribute to continuous improvement of MES validation strategies, procedures, and templates. Qualifications
Bachelor's degree in Engineering, Computer Science, Life Sciences, or related field. Advanced degree preferred. 7-10+ years of experience in Computer System Validation within GMP-regulated biologics/pharmaceutical manufacturing. Hands-on expertise with MES Syncade validation and configuration (recipes, workflows, batch records). Strong knowledge of regulatory guidelines: FDA 21 CFR Part 11, EU Annex 11, ICH Q7, GAMP 5. Experience in biologics manufacturing processes (cell culture, purification, fill/finish). Familiarity with integration points (DCS/DeltaV, LIMS, ERP/SAP, data historians). Excellent technical writing and documentation skills. Strong communication, leadership, and problem-solving abilities. Preferred Skills
Experience in large-scale biotech/biologics start-up or tech transfer projects. Knowledge of data integrity principles and ALCOA+ requirements. Exposure to quality management systems (TrackWise, Veeva, ValGenesis, Kneat). Understanding of 21st Century Cures Act and CSA (Computer Software Assurance) approaches. At
Pinnaql , people always come first. We believe that when you\'re empowered to do your best work, bold ideas thrive and real progress happens. This isn\'t just a job; it\'s your opportunity to make a meaningful difference. You\'ll help shape the future of healthcare and technology, working alongside a purpose-driven team that\'s as ambitious as it is supportive. We look forward to hearing from you! Pinnaql
is an equal opportunity employer. All applicants will be considered for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, veteran status, or disability status. #VTLS #ONSITE
#J-18808-Ljbffr