Job Description
Job Description Performs cGMP compliance-based services (commissioning, qualification, validation, consulting, etc.) as developed and defined in project agreements with IPS’ clients. Follows IPS and client standards and requirements, overall good industry practices for C/Q/V services and regulatory requirements. May also perform standalone commissioning services for non-FDA regulated clients.
Key Activities And Responsibilities - Write C/Q/V documents following established standards and templates, including but not limited to the following:
- Commissioning Forms
- C/Q/V Protocols and Summary Reports
- Standard Operating Procedures
- Impact Assessments
- Specifications (URS/FRS/DDS)
- FATS/SATs
- Perform field/site activities including, but not limited to, the following:
- Attend and witness FATs and SATs as a representative of IPS clients.
- Execution of commissioning forms and witnessing of vendor start-up and testing.
- Execution of C/Q/V protocols.
- Walkdown and verification of system drawings (P&IDs, as-builts, etc.)
- Compile data and prepare reports for completed C/Q/V activities including ETOPs, protocol data packages, etc.
- Assist in deviation investigation and resolution of problems and issues encountered during field execution activities.
- Work with the Project Delivery department or CM for start-up and vendor testing. Witness and troubleshoot as required.
- Primary responsibilities include C/Q/V of equipment and systems, including CSV and automation, supporting pharmaceutical, biotech, and medical device industries.
- Read, understand and utilize the IPS Best Practices and SOPs for delivery of compliance services
- Perform work to meet IPS budget requirements and quality standards. Provide consistent, complete, and timely feedback and reports to IPS project leaders, project managers, or management, of project status and issues, as requested.
- Other duties as assigned.
Qualifications & Requirements REQUIRED EDUCATION/QUALIFICATIONS /WORK EXPERIENCE - Associates or bachelor’s degree in related field preferred.
- Entry level position. 0 to 2 years of relevant experience.
- Experience in Pharmaceutical, Biotech, Medical Device Design, Construction, Commissioning, Validation, or QA. Experience in writing and execution of PFC, FC, IQ, OQ, and PQ forms/protocols for GMP Utilities, Equipment, Systems, and Software a plus.
- General exposure and experience in a GMP/Validation discipline with a knowledge and understanding of pharmaceutical Design/Build/Commission/Validate processes and how they relate to regulatory requirements and cGMP regulations within the E.U. and U.S. FDA helpful.
CONTEXT AND ENVIRONMENT AND SAFETY - This position will have up to 100% travel to site, or as required by the assigned project.
- Position may be assigned to client site for an extended period of time.
- Overnight travel or staying in the city of Client’s location is possible depending on assignment.
- Travel will be per the IPS Travel Policy, client specific travel policy or project specific travel plan.
- Position will visit Client sites and will be required to adhere to stated safety rules.
- Position 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.
- Empowers 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 and recognizes teamwork and champion’s 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 system.
- 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.
All interviews are conducted either in person or virtually, with
video required .
About Us IPS , a Berkshire Hathaway company, is a global leader in technical consulting, architecture, engineering, procurement, construction management, commissioning, qualification, and validation services for technically complex facilities.
Integration is how we think and work. It requires the ability to unite existing and emerging technologies into a process that reliably delivers products and accelerates speed to market. That end-to-end mindset allows us to be agile and anticipate challenges as we move projects toward operational readiness. IPS applies design and delivery expertise, client-side experience, and supplier-side insight to every project. We infuse our curiosity, our passion, and our commitment to partnership in delivering solutions at any scale. We meet our clients where they are and get them to where they need to go. That’s only possible when we care as much as our clients do.
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. Connect With Us!
If you do not meet the qualifications for this specific role, but would like to submit your resume for general consideration, please click here!
Job Tags
Work experience placement, Work at office, Night shift,