Senior Manager (OT/CSV) - Professional Service Operations

cGMPnow; North Carolina; Sur place; USD 150 000 - 210 000; Plein temps

Résumé du poste

cGMPnow is seeking a Senior Manager in Professional Service Operations to lead staff in Engineering work streams and oversee GMP computerized system implementations across FDA & EU regulated environments.

The role is hands-on with leadership responsibilities, managing scope, schedule, and budgets for capital projects, and coordinating with IT, QA, and clients on system upgrades and new deployments.

Qualifications

• Bachelor’s degree in an engineering discipline related to GMP/biotech.
• 8+ years as an engineer in GMP life-science environments.
• 5+ years leading project teams and/or managing clients on capital projects.
• 3+ years direct people management experience.
• Experience with design/validation of process control systems (DeltaV, PLCs).
• Experience with Windows-based OT control systems, AD, networking, backups.
• Experience with QC lab systems and associated LIMS.
• Familiar with ISPE Baseline Guides, FDA/EU regulations, cGMPs, risk-based design.
• Excellent leadership, communication, and client-facing skills.
• US work authorization (no sponsorship needed).

Responsabilités

• Develop and revise CSV project plans, WBS, and schedules.
• Provide project management to integrators/contractors to meet goals.
• Collaborate with IT, System Owner, Engineering, QA to implement systems.
• Define requirements to procure GMP computerized systems compliant with regulations.
• Develop and execute lifecycle documents (URS, Validation Plan, IQ/OQ/PQ, Data Integrity Evaluations).
• Support data integrity implementation and remediation for GMP systems.
• Maintain a controls implementation/data integrity strategy to improve compliance and efficiency.

Connaissances

Leadership

Client-facing

Communication

Budget management

Project management

Regulatory compliance

Formation

Bachelor's degree in Chemical, Mechanical, Bioengineering, Architecture, Electrical, or related engineering

Outils

DeltaV

PLC programming (Allen-Bradley)

HMI development

Active Directory / IT basics

LIMS (LabX, Empower, Softmax Pro)

Description du poste

The Senior Manager Professional Service Operations (PSO) is a technical leader responsible for management of staff within the Engineering work streams and the implementation of GMP computerized systems in FDA & EU regulated. The PSO staff manage the scope, schedule, and budget as well as execute the technical engineering on capital projects to FDA & EU regulated Advanced Therapeutic industries.

The successful candidate will have experience managing and executing the implementation of GMP manufacturing and/or laboratory computerized systems under a GAMP/SDLC framework. Projects will range in size from simple off the shelf systems to large enterprise systems.

This role is both hands-on and leadership-oriented. This position will directly support active projects as a Senior Engineer.

REQUIREMENTS:

• Bachelor’s degree in Chemical, Mechanical, Bioengineering, Architecture, Electrical, or related engineering discipline.
• 8+ years of experience as an engineer in GMP life-science environments
• 5+ years leading project teams and/or managing clients on capital projects within the Pharmaceutical, Biotech and Life Sciences Industries
• 3+ years of direct people management experience leading engineering teams
• Experience with design and validation of process control systems including DeltaV and PLCs (such as Allen-Bradley ControlLogix), programming in ladder logic and instructional texts, and HMI screen development and management
• Experience with design and validation of implementing and maintaining Windows-based Operations Technology control systems and related components including Active Directory, User Administration, Network Communication, and backup systems
• Experience with design and validation of implementing QC lab systems (Empower, Softmax Pro, LabX, etc.) and associated LIMS that support advanced therapeutics
• Knowledge and experience with facility design and manufacturing process in at least two of the following areas:
• Advanced Therapeutics Medicinal Products (ATMPs), such as autologous & allogeneic cell therapy, gene therapy, viral vector, stem cells, mRNA, and plasmid modalities
• Biologics and biopharmaceuticals, such as monoclonal antibodies (mAbs) or recombinant proteins
• Large molecules, including mammalian cell culture (e.g., CHO cells), microbial fermentation, anti-body drug conjugates (ADCs), and downstream purification modalities
• Small molecule therapeutics, such as chemical synthesis, crystallization, and Active Pharmaceutical Ingredient (API) production, drug product manufacture in solid oral dosage forms (tablets, capsules), including granulation, blending, tableting, and coating modalities
• Familiar with ISPE Baseline Guides, EU/FDA regulations, cGMPs, and risk-based design methodologies
• Excellent leadership, communication, and client-facing skills; able to influence decision-making at senior levels
• Able to work in the US without sponsorship now or any time or in the future

Technical Design / Problem Solving:

• Develop and revise CSV project plans, work breakdown structures and schedules.
• Provide project management to integrators and/or other contractors/vendors to ensure project goals are met
• Work closely with client project stakeholders (IT, System Owner, Engineering, QA) to effectively and efficiently implement new systems, system upgrades, or system modifications
• Define requirements to procure and implement GMP computerized systems that are compliant with applicable GMP/Data Integrity/Data Security regulations and industry standards.
• Develop, review and execute all computerized system life cycle documents (URS, Validation Plan, Specifications, Risk Assessment, Qualifications IQ/OQ/PQ, Data Integrity Evaluations, Trace Matrix, SOP’s, Validation Summary Report)
• Support data integrity implementation and remediation for GMP computerized systems.
• Develop and maintain a controls implementation/data integrity strategy that integrates process knowledge, equipment design, and quality standards with information technology to reduce downtime, elevate the level of regulatory compliance, and introduce efficiency gains through effective use of available technologies