Job Title: Validation Engineering Professional Senior
Duration: 14+ Months
Location: Conshohocken, PA 19428
Responsibilities:
As a commissioning, qualification, and validation (CQV) start-up/commissioning project manager, you’ll join our collaborative team that provides commissioning and start-up services to clients in the life sciences industry. The position provides an excellent opportunity to work for a Global Engineering Firm and support clients that manufacture life-changing products. This position is client-facing with an emphasis on ensuring Commissioning project deliverables meet schedule, cost, scope, quality, and safety. This position shall be responsible for the development of start-up and commissioning plans, commissioning documentation, and execution of these documents for a variety of facilities, utility systems, and equipment. This role serves a diverse client base of biotechnology, pharmaceutical, medical device, gene therapy, and cell therapy manufacturers. We are looking for a passionate CQV Commissioning Project Manager who is driven by collaboration, exceeding expectations, and challenging the status quo. You’ll be accountable for oversight, coordination, and execution of the start-up, energization, commissioning, and visual inspection of facilities, black and clean utility systems, HVAC, and production equipment.
You will also be responsible for the following duties:
• Develop Project Start-Up and Commissioning Plans and execution strategies.
• Lead the team in Developing System Start-Up and Commissioning Plans for black utility and HVAC systems.
• Led the team in Generating and executing Start-Up and Commissioning documents according to Good Documentation Practices (GDPs).
• Startup equipment in a safe and effective manner.
• Facilitate meetings for the start-up Team.
• Maintain action item lists.
• Maintain engineering change control logs.
• Provide technical assistance and input.
• Coordination of OEM Service technicians as needed.
• Coordination with construction management firm as needed.
• Apply engineering knowledge of, and experience with, HVAC, black utilities, instrumentation, controls, and automation to support clients.
Qualifications:
- BS in Mechanical, Electrical or Chemical Engineering or equivalent years of experience in lieu of degree.
- 5-14 years of Start-Up and Commissioning experience in the life sciences industry. Black utilities and HVAC start-up experience are required.
- Understanding of Good Manufacturing Practices (GMPs).
- Understanding of Good Documentation Practices (GDPs).
- Proficient with Microsoft Office – Word, Excel.
- Flexibility and willingness to travel and work at various clients’ locations.
- Ability to work well with diverse, multi-disciplined groups.
- Ability to effectively communicate with management and fellow project team members.
- Ability to negotiate/compromise with other project team members to achieve project goals.
- Ability to listen and respect fellow project team member’s ideas and opinions and work through conflicts or disagreements.
Ideally, you’ll also have:
- Proposal development experience.
- Knowledge of US FDA (21 CFR 210, 211, 810) and EU EMEA regulations.
Knowledge of industry guidance:
- ISPE Baseline Guide 5 Commissioning and Qualification.
- ISPE GAMP V, A Risk Based Approach to Compliant GMP Computerized Systems.
- ASTM E2500 Standard Guide for Specification, Design, and Verification of Pharmaceutical and Biopharmaceutical Manufacturing Systems and Equipment.
- ISPE Guideline: Science and Risk-based Approach for the Delivery of Facilities, Systems, and Equipment, 2011.
- ISPE Good Practice Guide: Applied Risk Management for Commissioning and Qualification, 2011.
- Six Sigma Certification.
About Us: Established in 2004, SPECTRAFORCE® is one of the largest and fastest-growing diversity-owned staffing firms in the US. The growth of our company is a direct result of our global client service delivery model that is powered by our state-of-the-art A.I. proprietary talent acquisition platform, robust ISO 9001:2015/ISO 27001 certified processes, and strong and passionate client engaged teams. We have built our business by providing talent and project-based solutions, including Contingent, Permanent, and Statement of Work (SOW) services to over 140 clients in the US, Canada, Puerto Rico, Costa Rica, and India. Key industries that we service include Technology, Financial Services, Life Sciences, Healthcare, Telecom, Retail, Utilities and Transportation. SPECTRAFORCE is built on a concept of “human connection,” defined by our branding attitude of NEWJOBPHORIA®, which is the excitement of bringing joy and freedom to the work lifestyle so our people and clients can reach their highest potential. Learn more at: http://www.spectraforce.com
Benefits: SPECTRAFORCE offers ACA compliant health benefits as well as dental, vision, accident, critical illness, voluntary life, and hospital indemnity insurances to eligible employees. Additional benefits offered to eligible employees include commuter benefits, 401K plan with matching, and a referral bonus program. SPECTRAFORCE provides unpaid leave as well as paid sick leave when required by law.
Equal Opportunity Employer: SPECTRAFORCE is an equal opportunity employer and does not discriminate against any employee or applicant for employment because of race, religion, color, sex, national origin, age, sexual orientation, gender identity, genetic information, disability or veteran status, or any other category protected by applicable federal, state, or local laws. Please contact Human Resources at LOA@spectraforce.com if you require reasonable accommodation.
California Applicant Notice: SPECTRAFORCE is committed to complying with the California Privacy Rights Act (“CPRA”) effective January 1, 2023; and all data privacy laws in the jurisdictions in which it recruits and hires employees. A Notice to California Job Applicants Regarding the Collection of Personal Information can be located on our website. Applicants with disabilities may access this notice in an alternative format by contacting NAHR@spectraforce.com.
LA County, CA Applicant Notice: If you are selected for this position with SPECTRAFORCE, your offer is contingent upon the satisfactory completion of several requirements, including but not limited to, a criminal background check. We consider qualified applicants with arrest or conviction records for employment in accordance with all local ordinances and state laws, including the Los Angeles County Fair Chance Ordinance for Employers (FCO) and the California Fair Chance Act (FCA). The background check assessment will consider whether a criminal history could reasonably have a direct, adverse impact on the job-related safety, security, trust, regulatory compliance, or suitability for this role. Such findings may result in withdrawal of a conditional job offer.
At SPECTRAFORCE, we are committed to maintaining a workplace that ensures fair compensation and wage transparency in adherence with all applicable state and local laws. This position’s starting pay is: $125.90/hr.
