SpiraTec AG
Overview
Senior CSV Lead/PM role at
SpiraTec AG . This is a 100% onsite role in Portsmouth, NH. You will work with our local and international team to deliver top-quality projects to our customers in the pharmaceutical manufacturing environment. Responsibilities
Manage the CSV team of 5 people with a strong background in Computerized System Validation and project management. Provide regular project updates, generate KPIs, and ensure adherence to budget and timelines. Lead the validation efforts for computerized systems including PCS (DeltaV), BAS (Rockwell), MES (Syncade), SCADA, and PLC systems. Support audits and inspections by providing documentation and justifications for validated systems. Work collaboratively with cross-functional teams including Engineering, IT, QA, QC, and Manufacturing. Communicate effectively with stakeholders, vendors, and regulatory authorities when needed. Participate in the implementation, commissioning, and qualification of DCS software (DeltaV), MES (Syncade), and related automation systems. Perform change assessments and manage change control processes for DCS and MES systems. What we appreciate about you
8+ years of CSV/Automation experience. Hands-on experience in implementation and validation of various computerized systems like PCS (DeltaV), BAS (Rockwell), MES (Syncade) and SCADA/PLC. Strong knowledge of Software Development Lifecycle (SDLC), including 21CFR Part 11/Annex 11, Data Integrity and computerized system validation requirements. Ability to work independently as well as within a team-oriented, collaborative environment. Extensive experience in project management including scheduling, monthly reports/KPIs and managing a CSV team. Author, review, approve and execute CSV lifecycle documentation as needed. Experience with commissioning and qualification of DCS software (DeltaV). Knowledge in change assessment for DCS software (DeltaV) and MES (Syscade). Extensive understanding of 21 CFR Part 11/Annex 11, GAMP5, and other regulatory guidance for computer/automation-based systems. Experience with QC systems is a plus, and familiarity with Kneat is preferable. Strong verbal and written communication skills. What awaits you at SpiraTec
Be part of a future-oriented company implementing innovative solutions based on the latest technologies and approaches (digitalization, Industry 4.0). We support our employees through training and offer opportunities to develop into a leadership role. SpiraTec is characterized by a team-oriented culture, flat hierarchies, short decision-making processes, and open communication. Onboarding is conducted in an agile manner with a personal buddy during your orientation period. All qualified applicants will receive equal consideration for employment without regard to race, color, national origin, religion, sex, pregnancy, marital status, sexual orientation, gender identity/expression, age, disability, genetic information, military service, protected veteran status, or any other protected class. Applicants must be authorized to work in the United States at the time of application. Would you like to become part of the team? Apply quickly and easily via our online application form. Seniority level
Mid-Senior level Employment type
Full-time Job function
Project Management and Information Technology Industries: Automation Machinery Manufacturing
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Senior CSV Lead/PM role at
SpiraTec AG . This is a 100% onsite role in Portsmouth, NH. You will work with our local and international team to deliver top-quality projects to our customers in the pharmaceutical manufacturing environment. Responsibilities
Manage the CSV team of 5 people with a strong background in Computerized System Validation and project management. Provide regular project updates, generate KPIs, and ensure adherence to budget and timelines. Lead the validation efforts for computerized systems including PCS (DeltaV), BAS (Rockwell), MES (Syncade), SCADA, and PLC systems. Support audits and inspections by providing documentation and justifications for validated systems. Work collaboratively with cross-functional teams including Engineering, IT, QA, QC, and Manufacturing. Communicate effectively with stakeholders, vendors, and regulatory authorities when needed. Participate in the implementation, commissioning, and qualification of DCS software (DeltaV), MES (Syncade), and related automation systems. Perform change assessments and manage change control processes for DCS and MES systems. What we appreciate about you
8+ years of CSV/Automation experience. Hands-on experience in implementation and validation of various computerized systems like PCS (DeltaV), BAS (Rockwell), MES (Syncade) and SCADA/PLC. Strong knowledge of Software Development Lifecycle (SDLC), including 21CFR Part 11/Annex 11, Data Integrity and computerized system validation requirements. Ability to work independently as well as within a team-oriented, collaborative environment. Extensive experience in project management including scheduling, monthly reports/KPIs and managing a CSV team. Author, review, approve and execute CSV lifecycle documentation as needed. Experience with commissioning and qualification of DCS software (DeltaV). Knowledge in change assessment for DCS software (DeltaV) and MES (Syscade). Extensive understanding of 21 CFR Part 11/Annex 11, GAMP5, and other regulatory guidance for computer/automation-based systems. Experience with QC systems is a plus, and familiarity with Kneat is preferable. Strong verbal and written communication skills. What awaits you at SpiraTec
Be part of a future-oriented company implementing innovative solutions based on the latest technologies and approaches (digitalization, Industry 4.0). We support our employees through training and offer opportunities to develop into a leadership role. SpiraTec is characterized by a team-oriented culture, flat hierarchies, short decision-making processes, and open communication. Onboarding is conducted in an agile manner with a personal buddy during your orientation period. All qualified applicants will receive equal consideration for employment without regard to race, color, national origin, religion, sex, pregnancy, marital status, sexual orientation, gender identity/expression, age, disability, genetic information, military service, protected veteran status, or any other protected class. Applicants must be authorized to work in the United States at the time of application. Would you like to become part of the team? Apply quickly and easily via our online application form. Seniority level
Mid-Senior level Employment type
Full-time Job function
Project Management and Information Technology Industries: Automation Machinery Manufacturing
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