Commissioning & Qualification Engineer - Intellectt INC
Philadelphia, PA
About the Job
Hello This is Komal from Intellectt we have an opening for a Commissioning & Qualification Engineer in PA. Please find the job details and description below and if interested You can reach me at komal@intellectt.com or call me at +1(732)-813-9025.
Job Title - Commissioning & Qualification Engineer
Location - 2 Ash Street, Pennsylvania
Job Title - Commissioning & Qualification Engineer
Location - 2 Ash Street, Pennsylvania
Job Description:
Location: Should be local to Wilson, NC or nearby. For the first 6 months of the role, it will be remote supporting sites in PA.
The role will officially move to the Wilson, NC site mid-year 2025 - NC work location: 5100 Corporate Parkway, Wilson, NC 27893
Location: Should be local to Wilson, NC or nearby. For the first 6 months of the role, it will be remote supporting sites in PA.
The role will officially move to the Wilson, NC site mid-year 2025 - NC work location: 5100 Corporate Parkway, Wilson, NC 27893
- Leading and coordinating the commissioning field team including CQ engineers, automation engineers, operator and site engineers, JSI sampling technicians, and external vendors and contractors.
- Ensures equipment usage is coordinated to support schedule development and avoids mutually exclusive activities are avoided.
- Lead and supervise a team of Piping/Mechanical, Electrical and Instrumentation technicians to support commissioning activities
- Coordinating the interfaces of commissioning execution (Construction Management Contractor, Utilities, Qualification, Automation, Instrumentation, Electrical, etc.)
- Lead daily coordination meetings to fine-tune the commissioning execution with all involved parties
- Tracking and reporting of commissioning progress
- Tracking of deficiencies, including planning and executing the remediation actions
- Ensuring compliance of the commissioning activities with qualification requirements where test results are subject of leveraging
- Reviewing commissioning test documents prior to client approval
- Technical SME provide mentorship for team members in supporting issue resolution and consistency in approach across the team.
- Co-ordinates the management of change
- Ensuring full compliance with safety procedures and ensuring permits, SPA, RAMS are in place for area commissioning activities.
- Adhere to and monitor the schedule and timeframes milestones within the schedule. Work with CQV scheduler to prepare and communicate 4 week lookahead plans and micro-schedules as required.
- Manage and close out of exceptions during static and dynamic commissioning
Preferred Qualifications:
- BSc qualification (Engineering related discipline).
- At least 10 years' experience in a Drug Substance Biotech manufacturing environment.
- At least 10-15 years C and Q experience and a proven track record within a cGMP regulated environment.
- At least one major Biotech project as a C and Q Lead.
- Planning and organizing skills.
- Excellent interpersonal and influencing skills
- Excellent written and oral communication skills.
Desirable
- Experience of Digital C and Q systems.
- Strong knowledge of Commissioning and Qualification Regulations and Standards.
- Ability to work under pressure and meet deadlines.
- Ability to work in a team, coordinate colleagues, contractors and consultants.
- Strong initiative and the ability to proactively identify required tasks.
- An organized approach to working, task prioritization and time management.
Special Credentials / Certifications Required:
- Must have C and Q start up experience of Large Molecule Downstream processes
Total working Experience:
- 10+ years C and Q
Source : Intellectt INC
