IT Project Manager

Petersburg, VA - USA

Yearly Salary: USD 90000 - 100000

Posted on: 22 hours ago

Vacancies: 1 Vacancy

Job Summary

About Us

At cGMP Consulting we specialize in providing expert validation qualification and compliance services to the life sciences industry. Our team works with clients to ensure their facilities equipment and processes meet regulatory standards enabling the safe and efficient production of pharmaceuticals.
cGMP Consulting is based in Lake Forest IL. Our main client locations are Melrose Park IL North Chicago IL Waukegan IL and Pleasant Prairie WI. This project is located in Petersburg VA.

Position Summary
cGMP Consulting is seeking an experienced IT Project Manager with a strong background in pharmaceutical manufacturing to lead technology initiatives that support compliant efficient and digitized production operations. This role is responsible for planning implementing and governing IT projects that impact GMP environments manufacturing systems and enterprise technology platforms.

The ideal candidate has a proven track record managing cross-functional projects in regulated industries and understands the unique intersection of IT automation quality and manufacturing operations.

Responsibilities

The essential functions include but are not limited to the following:

Lead end-to-end project lifecycle activities including scope definition requirements gathering scheduling resourcing budgeting risk management and execution.
Manage multiple concurrent IT and manufacturing systems projects (e.g. MES ERP LIMS automation integrations data platforms).
Develop clear project plans charters and communication strategies for stakeholders across IT Quality Manufacturing Supply Chain and Engineering.
Partner with manufacturing QA validation and engineering teams to align project delivery with GMP and operational needs.
Facilitate workshops requirements sessions and steering committee updates.
Coordinate with external vendors software providers and system integrators.
Ensure all IT project deliverables meet GxP 21 CFR Part 11 Annex 11 and internal quality system requirements.
Work with QA and CSV/validation teams to develop validation plans protocols and documentation aligned with software development life cycleand industry best practices.
Maintain project documentation consistent with audit and regulatory expectations.
Support implementation and enhancement of manufacturing technology such as MES (e.g. Werum PAS-X Rockwell PharmaSuite) ERP (e.g. SAP S/4HANA) LIMS / ELN SCADA equipment integration data historians (e.g. PI) Serialization traceability and digital quality systems.
Translate business and manufacturing requirements into system specifications and functional designs.
Troubleshoot and escalate complex technical issues with appropriate teams.
Drive process standardization integration and digital transformation initiatives within manufacturing IT.
Identify opportunities to optimize system performance data flows and compliance posture.
Contribute to long-term technology roadmaps and system upgrades.

Requirements

Bachelors degree in Information Technology Computer Science Engineering or related field.
5 years of IT project management experience with at least 3 years in pharmaceutical biotech or regulated manufacturing.
Strong understanding of GMP CSV GxP regulations and computerized system validation.
Demonstrated success leading cross-functional IT/mfg system projects.
Excellent communication organizational and stakeholder management skills.
Experience with common project methodologies (Waterfall Agile or hybrid).

Compensation and Benefits

Expected pay range per year: $90000-$100000USD
Expected benefits include: Medical Dental Vision PTO 401K

Disclaimer

The duties and responsibilities described are not a comprehensive list and additional tasks may be assigned to the employee from time to time; or the scope of the job may change as necessitated by business demands. All duties and responsibilities are subject to possible modification to reasonably accommodate individuals with disabilities. The requirements listed are the minimum levels of knowledge skills or abilities necessary to perform this job successfully. The company is an Equal Opportunity Employer drug-free workplace and complies with ADA regulations as applicable.

Required Experience:

Senior IC

About UsAt cGMP Consulting we specialize in providing expert validation qualification and compliance services to the life sciences industry. Our team works with clients to ensure their facilities equipment and processes meet regulatory standards enabling the safe and efficient production of pharmace...