JOB OPENINGS

Job Description:

STEP Management Incorporated provides project management services for domestic and international customers in the biotech, medical, pharmaceutical, construction and banking industries. The STEP Management company principles focus on being Strategic, Thorough, Efficient, and Professional while providing our customers the highest level of quality possible.

STEP Management Inc. is seeking an experienced Project Manager to oversee the planning and execution of equipment, process, and computer validations. Incumbent will be responsible for ensuring all project activities comply with existing regulatory requirements and assuring documentation meets both internal and external standards. This position must maintain current knowledge and awareness of pharmaceutical cGMPs, industry trends, and guidance documents issues by various international regulatory agencies (FDA, EMA, ect.).

The incumbent will successfully manage the projects from inception to completion. They will be responsible for working with the client to generate the project scope, timeline, and drive actions to ensure timely completion of all key deliverables. Additionally, the Validation Project Manager will publish monthly project updates and work closely with the client to ensure that that the customer’s requirements are satisfied.

This position will report directly to the President of the company and will work closely with the Project Sponsor and stakeholders within the client’s operations group to create a synergistic and cost-effective solution for the stated project.

Responsibilities:

  • Develop/maintain validation of equipment and/or processes, cleaning, steaming, shipping, computer and automation systems for client.
  • Develop, review, and/or revise validation master plans and SOPs. Ensure that all comply with regulatory requirement.
  • Develop, review and approve validation protocols. Analyze validation data against established acceptance criteria. Ensure documentation is available for operational activities.
  • Provide coaching regarding process, cleaning, equipment, utilities, facilities and computer related validation activities and help maintain a validated state of control.
  • Provide expertise/guidance on change controls impacting validated systems and identify test methods/strategies for qualification of new equipment/systems.
  • Work with client to maintain organization and archival of completed validation and qualification document packages.
  • Perform impact assessments regarding changes to validated systems and processes and the introduction of new equipment/system and/or process/product.
  • Lead investigation and resolution of validation related deviations and complete all required documentation.
  • Interface with contract manufacturers to address documentation and compliance issues. May interface with regulatory agencies as required.
  • Build and maintain a strong working relationship with all internal and external operational groups.

Qualifications: The successful candidate must have:

  • BS in technical field with a minimum 10 years of work experience in validation, quality engineering or quality assurance roles.
  • Experience in pharmaceutical/biotech operations with thorough working knowledge of production unit operations, cGMPs, FDA regulatory guidelines and validation principles.
    Knowledge of ISO 13485 as well as 21 CFR Part 11 requirements desired.
  • Training in Validation Process, Statistical Process Controls, Design of Experiments and Six Sigma. Preference given to Green or Black Belt certification.
  • Strong computer skills are required. Proficiency in Microsoft Office (Word, Excel, Access and PowerPoint) as well as MS Project. Must be highly proficient with using statistical data analysis software (i.e. Minitab, JMP, SPSS).
  • Experience reviewing validation and regulatory documents/reports to assure compliance.
  • Strong interpersonal skills with ability to achieve consensus and cooperation with personnel of various backgrounds and personalities.
  • Strong written and verbal communication skills and technical writing skills are critical.
  • Track record of implementing successful validation projects with quantifiable results.
  • Unwavering commitment to safety.
  • Conducts project review meetings with senior executives.
  • Motivational mindset with ability to inspire team to meet success criteria.

Contract opportunities (6-12 month) with an established and growing company! Please send resume, references, and salary requirements to [email protected].

IMMEDIATE HIRE

Role Type: W2 Contract Consultant
Location: RTP, NC, Hybrid potential
Hours per week: 40 hours
Duration of Role: approximately 3 years
Salary Range: Negotiable depending on experience

Objectives/Purpose:

  • Familiarity with Project Controls principles and methods including, but not limited to: Budgeting and Forecasting, Change Ownership Systems / Procedures, Work Breakdown Structures, Earned Value Systems, Contingency, Schedule Planning, development, updating, and resource loading
  • The Project Controller is accountable to develop, progress and forecast all phases of the project schedule/plan using the most current industry practices and software for a new facility build; TIC $300-500M
  • Set up, monitor, and forecast all cost elements on the project, including scope changes, while inputting or updating budget information, expenditure information, and forecasts into the cost reporting system(s).

Education, Behavioral Competencies, and Skills:

  • Provide planning leadership and integrate with engineering, procurement, cost, technical & construction disciplines for seamless reporting to insure effective Capital Project Delivery
  • Demonstrated knowledge of engineering, procurement, construction, and qualification (EPCMQ) processes in the Pharma/Biotech Industry
  • Manage day-to-day operation of the accounting department & will report to the organizational CFO and interface with the Project Manager.
  • Budgeting, forecasting & analyzing cost, and profits by project
  • Ability to facilitate and manage contractor payments utilizing AIA process.
  • Have operational involvement with project managers on job costs, margins, and forecasting
  • Ability to gather and establish risk and risk management mitigation strategies
  • Maintain state registrations, business, and tax licenses, etc.
  • Performs analytical review of reports generated in controlling software
  • Provide project forecasting and budget tracking and variances; Prepare monthly cash projection reports
  • Utilizes computer software systems for the preparation of reports, spreadsheets and other accounting analysis that may be required by management
  • Maintains all project's operating accounts including deposits, disbursements, and balancing
  • Supports local as well as in certain regional teams, including team members located internationally
  • Ensures accuracy and completeness of master data including resource information, project, activity, and resource codes, enterprise project structure, security profiles, licensing information, etc.
  • Participates in the development of the work breakdown structure, interfacing with Procurement, Engineering, and Finance Departments
  • Prepares monthly aged trial balances, job cost summary schedules, supporting schedules for month-end close
  • Track variations and inconsistencies with ability to resolve and communicate solutions
  • Teamwork - Ability to work well in highly cross functional team environment and across global line functions.
  • Communication Skills -Able to express and articulate clearly and concisely within team; documents issues and/or concerns concisely with colleagues; adjusts communication style as appropriate for the audience; timely and effectively communicates issues to project sponsor; technical writing skills to support authorship of internal technical documents
  • Perform other duties and ad hoc requests as needed

Required Skills

  • BS or M.S. Finance, Accounting, or related degree
  • SAP
  • Ten (10) years of progressive finance and accounting experience
  • Excellent strategic, problem solving, and analytical skills.
  • Construction, Accounting, Payroll, Union Payroll experience is necessary
  • Ability to work well as an integral part of a large project team
  • Ability to collaborate with team and problem solve
  • Proficient with Microsoft Office Suite or related software.
  • Strong written and verbal communications, including critical thinking skills
  • Broad knowledge of GAAP and related internal control structures for financial accounting, project controlling and reporting systems and processes

Highly Preferred Skills

  • Must be a self-motivated and driven professional who can effectively perform in a rapidly changing environment
  • Must be able to work independently, but is also a team player with strong collaborative skills
  • Working knowledge of biotech manufacturing operations and process knowledge; cGMP environment and familiarity with aseptic manufacturing is a plus
  • Strong understanding of contract terms and able to execute in the field
  • Excellent project control (cost control and scheduling) skills
  • Great communicator and problem solvers, who display strong servant leadership skills
  • Ability to work with multi-disciplined teams to accomplish project objectives
  • Project development and/or project finance experience
  • Motivational mindset and attitude with ability to inspire team to meet success criteria

About Us:
STEP Management, Incorporated provides project management, program management, and strategic planning services for domestic and international customers in the biotech, medical, pharmaceutical and construction industries.  Our company principles focus on strong values of integrity, accountability, and trust.  We build long lasting relationships while providing customer focused solutions centered on strategy, focus, efficiency, and the highest level of quality possible.

STEP Management, Incorporated provides equal employment opportunities (EEO) to all employees and applicants for employment without regard to race, color, religion, sex, national origin, age, disability, or genetics. In addition to federal law requirements, STEP Management, Incorporated complies with applicable state and local laws governing nondiscrimination in employment in every location in which the company operates. This policy applies to all terms and conditions of employment, including recruiting, hiring, placement, promotion, termination, layoff, recall, transfer, leaves of absence, compensation, and training.

Professionalism:
As the Project Team Member will be working on behalf of and in representation of our client, it is our expectation that the Team Member carry themselves with a high level of professionalism, cooperation, and within the policies of the client. It should be noted that the while the Project Team member is working on behalf of client, that the Project Team member should not engage in a direct consulting relationship with the suppliers within the scope of this project without the express written agreement from client.  The Project Team members will report operationally to the client manager assigned to the project for supplier assignment and supervision of the project.

STEP Management, Inc. is seeking an experienced Program / Project Manager-PM to oversee the planning and execution of capital projects in a manner consistent with our guiding principles of safety, quality, and efficiency. The incumbent will successfully manage the projects from inception to completion.  You will be responsible for working with the client to generate the project scope and timeline, develop the capital budget, manage resources and external vendors and contractors, ensure timely completion of all key deliverables, and meet cost targets.  Additionally, the PM will publish project status updates and work closely with the client to ensure that the customer’s requirements are satisfied.  As the designated point of responsibility, the PM will provide company integration, direction and oversight of all project engineering, procurement, construction, and startup activities.

We are seeking well-qualified candidates to join our team who couple their experience with a winning attitude, ability work well in dynamic environments, enjoy challenging opportunities, and are flexible.
The PM will work closely with the Project Sponsor and stakeholders within the client’s operations group to create a synergistic and cost-effective solution.

Responsibilities:

  • Interface with contractor(s) to ensure alignment on customer deliverables and management of stakeholder expectations
  • Provide oversight of scope, schedule and budget for assigned areas on construction site
  • Assist in the development of feasibility studies, cost estimates, scope and project execution documents
  • Manage the execution of multi-million-dollar project:
  • Oversees project team and resolves technical and operational issues
  • Manages project cost schedule and scope within the project's defined boundaries
  • Develops budget and schedule variance reports and presents to senior management on a regular basis
  • Helps team to identify, evaluates and effectively manage project risks to ensure proper mitigations are in place
  • Completes proper project closing procedures to ensure a “ready to operate” state for the client
  • Conduct project review meetings with various levels of project team and client staff
  • Identify innovative opportunities that enhance the quality of, decrease the cost of, and reduce time to complete capital projects
  • Ensure uniform quality, schedule and budget for all design and construction projects
  • Ensure compliance with federal, state and local regulatory agency-required guidelines
  • Effectively communicates and escalates as needed to ensure scope, schedule, budget, and quality are aligned with contract deliverables
  • Track any variations and/or inconsistencies for items to be addressed by responsible party

Required Qualifications: 

  • BS or MS in Engineering or technical discipline
  • Minimum 10 years’ experience in managing construction or large scale multi-disciplinary projects and 5 years of project management experience.

Desired Qualifications:

  • PMP certification
  • Knowledge and experience with cGMPs and sterile environment
  • Strong understanding of contract terms and able to execute in the field
  • Solid communication skills; verbal and written
  • Excellent project control (cost control and scheduling) skills
  • Knowledge of codes, regulations, and industry standards & practices including OSHA-required health and safety guidelines for construction
  • Unwavering commitment to safety
  • Ability to direct multi-disciplined teams to accomplish project objectives
  • Project development and/or project finance experience
  • MS Project experience
  • Motivational mindset and attitude with ability to inspire team to meet success criteria

Local candidates preferred, but not required.  This is a W2-Contract opportunity with a minimum duration of 12 months.

Come and be a part of an exciting and growing company! Please send resume and salary requirements to [email protected].

About Us:

STEP Management, Incorporated provides project management services for domestic and international customers in the biotech, medical, pharmaceutical and construction industries.  The company is based on over 30 years of managing projects in the pharmaceutical, biotech, construction, and technology industries. We utilize a unique approach to managing projects as we guide our customers through the project process phases one step at a time. Understanding the project risks and developing robust mitigation plans is a key part of our process.  At STEP Management, we have a passion for projects, and even more so, developing successful people through those opportunities.

STEP Management, Incorporated provides equal employment opportunities (EEO) to all employees and applicants for employment without regard to race, color, religion, sex, national origin, age, disability or genetics. In addition to federal law requirements, STEP Management, Incorporated complies with applicable state and local laws governing nondiscrimination in employment in every location in which the company operates. This policy applies to all terms and conditions of employment, including recruiting, hiring, placement, promotion, termination, layoff, recall, transfer, leaves of absence, compensation, and training.

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