Validation Project Manager

GBA Team•Broomfield, CO

1d•$140,000 - $150,000•Onsite

About The Position

Build Your Future with GBA/Compli Compli, LLC was founded in 2001 to provide Commissioning, Validation and Regulatory Support Services to the Life Sciences industry. We serve pharmaceutical companies across the United States, offering a vast array of services that assist companies with exceeding their goals and objectives. In todays world, its never been more important to understand regulations and quality assurance activities as they relate to operations, vendors, engineering, construction and contractors. In 2020, Compli, LLC became a wholly owned subsidiary of George Butler Associates, Inc. This acquisition allowed Compli, LLC to become part of an integrated network of services where clients have more options to engage an impressive suite of in-house services. Compli is full services Commissioning, Qualification, Regulatory Compliance and On Demand services firm. What You'll Do: Manages stand-alone validation projects or commissioning and validation of major projects under Project Director. Responsible for providing general direction to lead and supervisory personnel. Trains team members to access departmental data files and procedures in order to facilitate job assignments. Prepares and reviews procedures and guidance documents for departmental use. Assumes responsibility for primary contact with other project personnel. Responsible for project budget and schedule performance. Reports on progress and project status and manpower requirements. Evaluates performance of project team members. Responsible for ensuring quality of work performed and associated deliverables Other duties as assigned. What You'll Bring Bachelors degree in Engineering (mechanical, electrical, chemical, or industrial) or equivalent is preferred. Minimum 10+ years validation or CGMP-related; three years project lead experience. Experience with large scale CAPEX industrial projects and disciplines such as heavy civil, structural, mechanical, and electrical scopes. Technical Skills & Abilities : Experience with process equipment and commissioning activities Sector experience in an industry where Engineering / Construction / Operations / Projects are key business driver. Heavy Industrial construction with a Prime Contractor, EP&C, or owner-side major projects group experience would be ideal for this position. Knowledge is based on a broad and thorough understanding of pharmaceutical processes and related systems, techniques used in validation and applicable CGMP regulations. Provides innovative solutions based upon knowledge and experience. Ability to influence decision making within a project team. Excellent oral and written communications skills and ability to communicate at all levels of the organization. Experienced in using TEAMS, Outlook, Microsoft Word, Microsoft Excel, Visio and PowerPoint Physical Requirements : Working at a variety of heights Climbing stairs and ladders Bending Stooping Working outdoors in a broad range of climate conditions Working around construction machinery Additional Information: Collaborating with a large team that are scattered across the globe requiring online meetings Long hours (minimum 45 hours) during construction and commissioning is expected with possible weekend work at times Expected to identify gaps and personally solve them without depending on staff

Requirements

Bachelors degree in Engineering (mechanical, electrical, chemical, or industrial) or equivalent is preferred.
Minimum 10+ years validation or CGMP-related; three years project lead experience.
Experience with large scale CAPEX industrial projects and disciplines such as heavy civil, structural, mechanical, and electrical scopes.
Experience with process equipment and commissioning activities
Sector experience in an industry where Engineering / Construction / Operations / Projects are key business driver.
Knowledge is based on a broad and thorough understanding of pharmaceutical processes and related systems, techniques used in validation and applicable CGMP regulations.
Provides innovative solutions based upon knowledge and experience.
Ability to influence decision making within a project team.
Excellent oral and written communications skills and ability to communicate at all levels of the organization.
Experienced in using TEAMS, Outlook, Microsoft Word, Microsoft Excel, Visio and PowerPoint
Working at a variety of heights
Climbing stairs and ladders
Bending
Stooping
Working outdoors in a broad range of climate conditions
Working around construction machinery
Collaborating with a large team that are scattered across the globe requiring online meetings
Long hours (minimum 45 hours) during construction and commissioning is expected with possible weekend work at times
Expected to identify gaps and personally solve them without depending on staff

Nice To Haves

Heavy Industrial construction with a Prime Contractor, EP&C, or owner-side major projects group experience would be ideal for this position.

Responsibilities

Manages stand-alone validation projects or commissioning and validation of major projects under Project Director.
Responsible for providing general direction to lead and supervisory personnel.
Trains team members to access departmental data files and procedures in order to facilitate job assignments.
Prepares and reviews procedures and guidance documents for departmental use.
Assumes responsibility for primary contact with other project personnel.
Responsible for project budget and schedule performance.
Reports on progress and project status and manpower requirements.
Evaluates performance of project team members.
Responsible for ensuring quality of work performed and associated deliverables
Other duties as assigned.