SpiraTec AG
We are seeking a highly skilled and experienced Senior CSW Lead/PM. In this 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.
What are your responsibilities
You will 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 validates 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 controll processes for DCS and MES systems. What we appreciate about you
You have 8+ years of CSV/Automation experience. Hands-on experience in implementation & 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. Your are experienced at working independently as well as in a team-oriented, collaborative environment is essential. Extensive experience in project management including scheduling, monthly reports / KPIs and manage CSV team. Author, review, approve and execute CSV life cycle documentation as needed. Experience working with and commissioning & 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 associated with computer/automation--based systems. Experience with QC systems is a plusand with Kneat is preferable. You have strong verbal and written communication skills. What awaits you at SpiraTec
Be part of a future-oriented company and implement innovative solutions with us based on the latest technologies and approaches (digitalization, Industry 4.0). We support our employees individually through training and offer the oppertunity to develop into a leadership role. SpiraTec is characterized by a team-oriented work culture, flat hierarchies, short decision-makting processes and an open communication culture. With us, you will find an agile onboarding and 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, covered/protected veteran status or any other federal, state or local 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.
What are your responsibilities
You will 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 validates 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 controll processes for DCS and MES systems. What we appreciate about you
You have 8+ years of CSV/Automation experience. Hands-on experience in implementation & 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. Your are experienced at working independently as well as in a team-oriented, collaborative environment is essential. Extensive experience in project management including scheduling, monthly reports / KPIs and manage CSV team. Author, review, approve and execute CSV life cycle documentation as needed. Experience working with and commissioning & 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 associated with computer/automation--based systems. Experience with QC systems is a plusand with Kneat is preferable. You have strong verbal and written communication skills. What awaits you at SpiraTec
Be part of a future-oriented company and implement innovative solutions with us based on the latest technologies and approaches (digitalization, Industry 4.0). We support our employees individually through training and offer the oppertunity to develop into a leadership role. SpiraTec is characterized by a team-oriented work culture, flat hierarchies, short decision-makting processes and an open communication culture. With us, you will find an agile onboarding and 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, covered/protected veteran status or any other federal, state or local 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.