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Posted: 02-Feb-23
Location: Cary, North Carolina
Type: Full Time
Categories:
Sector:
Salary Details:
Preferred Education:
Additional Information:
Internal Number: CQV01
Solicitations from recruiting services are not accepted.
RGD Project Management, Inc. is a growing company based in Cary, NC. Our employees specialize in providing Project Management, Program, Construction Management & Technical Support Services in the construction of industry leaders in biotechnology, pharmaceutical, high tech & industrial companies. These services are related to the implementation of capital projects throughout the project lifecycle: project feasibility analysis, funding, scope & estimates, pre-construction, engineering & design, construction, commissioning & validation. For 23 years, we have set our standards high to ensure that our team is one of the best in the industry. Safety, efficiency, quality, cost & schedule are our foundation.
Join a company focused on teamwork, individual growth & family values.
Pharmaceutical Commissioning, Qualification and Validation Engineer (CQV)
The CQV team develops documentation and executes commissioning, qualification and validation/verification for RGD’s clients for their utilities, equipment and processes. Areas of expertise include:
Clean Utilities
- Purified Water
- WFI
- Clean Steam
- Pure Steam
- Nitrogen
- Compressed Air
Upstream and Downstream Processes
- Cell Culture
- Filtration
- Formulation
- Lyophilization
- Fill/Finish
- Assembly
- Serialization
- Inspection
- Packaging
Leading Technologies
- Cell Therapy
- Gene Therapy
- Biotechnology
- Biotherapeutics
- Parenterals
- Solid Dose/Powders
- Vaccine Development
Duties
- Write protocol, execution, field verification and summary reports
- Investigate and resolve discrepancies in protocol
- Develop tech reports and summary reports
- Read and verify facility and equipment drawings
- Develop Standard Operating Procedures, Validation Plans, Turnover Packages and other documentation
- Conduct validation testing for equipment to meet qualifications for production
- Facilitate turnover of equipment to be qualified and put into production
Requirements:
Successful candidates should have the following knowledge, skills and capabilities:
- Ideal applicant will have 1-5 years proven experience (more for senior positions) in the planning, engineering, construction, commissioning or validation with pharmaceutical facilities preferred.
- Understanding of standard operating procedures and documentation in the pharmaceutical industry a must.
- Direct experience with regulated environments (i.e. cGMP, OSHA, EPA) required
- Experience in pre-design and pre-construction, building systems/components and technology is a plus.
- Strong verbal and written communication and negotiation skills
- Special consideration will be given to candidates with knowledge or expertise in PLCs, DCS, BMS, DeltaV, ABB or other controls systems.
- Ability to occasionally work non-standard work hours in support of projects
- Ability and willingness to commute 25-100 daily depending on assignment.
RGD is an equal opportunity employer who offers full-time employees a comprehensive package of benefits that include medical insurance (BCBS), dental and vision insurance, life insurance. Benefits also include paid vacation days, sick days, holidays and 401(k) with generous employer contributions. Full-Time employment is eligible to qualified and experienced applicants only. U.S. Citizenship or U.S. Permanent Resident Visa required.
- Bachelor's Degree or equivalent experience
- Strong business acumen in project planning and management
- Strong verbal, written, and organizational skills
Special consideration will be given to candidates with experience in construction of any of the following:
- High purity piping/WFI/clean utilities
- Clean Rooms/Modular clean room panels
- Aseptic suites
- Single-use technology
- Bioreactors/Cell culture
- Recovery
- Purification
- Fermentation
- Formulation
- Fill/Finish
- Packaging/Assembly
Candidates will be considered for Project Manager, Construction Manager or other positions commensurate with experience, knowledge or expertise.
Candidates must:
- Pass a pre-employment background check and drug screening
- Have the means and willingness to commute 25-100 miles daily
- Be legally eligible for employment at the time applying
