Job Description:
In this role, you will perform non-pharma and cGMP commissioning-based services with a primary focus on standalone commissioning.
You will also consult on and manage commissioning projects as developed and defined in project agreements with IPS clients.
Further duties will include performing site auditing, quality reviews, and commissioning services as required to meet project requirements.
Additionally, you will develop business opportunities and projects with a primary focus on commissioning and related consulting.
What You'll Do Provide working knowledge in the delivery of technical projects in these areas.
Provide consulting-based services in areas of expertise.
Manages project teams delivering primarily standalone commissioning.
Provides client management functions.
Works with Regional Compliance Managers to manage the utilization goals of a focused team.
Support, train, mentor, and guide Commissioning Consultants and overall department staff in the delivery of commissioning services and areas of expertise.
Perform commissioning-related audits of clients facilities and quality systems.
Assumes Project Management / Project Executive roles as requested and required to meet IPS workload demands.
Remains highly active in professional organizations and strives to be recognized in the industry.
Provides training and seminar presentations to the industry.
Networks at all professional functions and develops project leads and opportunities through industry contacts.
Supports BD activities through networking.
Works with IPS department managers to develop and apply quality practices for all project deliverables and business practices.
In conjunction with the department managers, performs project audits to ensure all project goals are being met and compliance services are offered as a value-added product to IPS clients.
Generates and performs commissioning deliverable activities, audits, and other related services as required, to meet project requirements and personal billability goals.
Works with potential new and existing clients to initiate projects following current industry practices.
Performs strategic and master planning activities to ensure projects are initiated/started on the right foot.
Other duties as assigned.
Qualifications & Requirements: 7+ years of experience in Pharmaceutical, Biotech, Medical Device Design, Construction, Commissioning, Validation, or QA.
CxA Certified.
Experience with commissioning and other CQV activities and processes.
Detailed experience in a commissioning discipline with a knowledge and understanding of pharmaceutical Design/Build/Commission/Validation processes and how they relate to regulatory requirements and cGMP regulations within the E.U.
and U.S. FDA.
Familiar with LEED commissioning requirements and California Title 24 Building Energy Efficiency Standards.
Demonstrated/recognized areas of expertise by industry in start-up & commissioning.
Preferred Qualifications
Bachelor of Science in Engineering or Bachelor of Science in a related field.
Context & Safety
This position will have up to 100% travel to the site, or as required by the assigned project.
Position may be assigned to the client site for an extended period of time.
Overnight travel or staying in the city of the Clients location is possible depending on the assignment.
Travel will be per the IPS Travel Policy, client-specific travel policy, or project-specific travel plan.
You will visit Client sites and will be required to adhere to stated safety rules.
You may visit active construction sites and will be required to take site safety training and adhere to site safety rules.
This position is a safety-sensitive position.
The employee is designated for field work and attends activities at client sites where they work in construction, process, packaging, manufacturing, research, or other "non-administrative" areas.
Demonstrated Competencies
Proficiency with Microsoft Office applications (Word, Excel, Project, PowerPoint, etc.).
Personal skills and traits include: Sense of urgency Team player Able to multi-task Effective time management Able to effectively prioritize Good interpersonal skills Attention to detail Excellent customer service skills Leads by example.
Deems the respect of upper management, peers, and subordinates.
Empower staff to succeed.
Supports and deploys technical training programs that assure competency and advancement levels to support corporate goals.
Promotes a friendly and efficient work environment, which rewards achievement, recognizes teamwork, and champions technical advancement, which supports our corporate goals.
Maintain professional conduct and deliver services in a professional and acceptable fashion.
Works in conjunction with department management in recruiting new staff members and promoting IPS to potential hires (focused on cleaning and process validation).
Core Value Candidate Qualifications
Must exhibit an entrepreneurial spirit by consistently seeking new opportunities to add value to the organization.
Must strive for excellence in all aspects of job performance.
Must approach their work enthusiastically with a contagious energy and drive that shows everyone they love what they do.
Must display creativity and innovation by continually working to improve solutions, tools, methods, and service delivery systems.
Must conduct oneself with an uncompromising commitment to the welfare of our clients and each other.
Must act in an ethical, professional, and respectful manner at all times.
Must exhibit the ability to build and sustain long-term relationships of mutual value through teamwork.
Must be driven to succeed and committed to goal attainment.
About Us:
IPS, a Berkshire Hathaway Company, is a global leader in developing innovative business solutions for the biotechnology and pharmaceutical industries.
Through operational expertise and industry-leading knowledge, skill, and passion, IPS provides consultancy services, architecture, engineering, project controls, construction management, and compliance services that allow clients to develop and manufacture life-impacting products.
Its newest acquisition, Linesight, specializes in cost, schedule, risk, program, and project management services in various market sectors, including data centers, life sciences, and high-tech industries.
With the addition of Linesight, IPS has over 3,000 professionals in over 45 offices across 17 countries in the Americas, Europe, Asia Pacific, Southeast Asia, Australia, and the Middle East.
Specialties
Process Architecture, Process Design, Engineering, Construction, Commissioning, Qualification, LEAN Project Delivery, Strategic Master Planning, Energy Conservation Management, Project Controls, Program/Project Management, Operations/Logistics Strategy and Planning, EPCMV and Staffing Services.
All qualified applicants will receive consideration for employment at IPS without regard to race; creed; color; religion; national origin; sex; age; disability; sexual orientation; gender identity or expression; genetic predisposition or carrier status; veteran, marital, or citizenship status; or any other status protected by law.
IPS is proud to be an affirmative action and equal opportunity employer.
Attention Search Firms / Third-Party Recruiters: IPS is not seeking assistance or accepting unsolicited resumes from search firms for employment opportunities with IPS.
Regardless of past practice, all resumes submitted by search firms to any employee at IPS via email, the Internet, or directly to hiring managers at IPS in any form without a valid written search agreement in place for a specific position will be deemed the sole property of IPS, and no fee will be paid in the event a candidate is hired by IPS as a result of the referral or through other means. Salary range for this role is $120,000 to $175,000 depending on skills and industry experience.
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