SENIOR EQUIPMENT VALIDATION ENGINEER - Indiana - To $100K
Visible role with one of the largest solid dose manufacturers in the US. This person will manage multiple validation/equipment qualification projects related to solid dose equipment, i.e. granulation/mixing, compression, encapsulation and others. A BS degree in an engineering or scientific discipline is required along with 6+ years of validation/equipment qualification experience within a tablet/capsule production environment. Salary range is broad-banded and will depend on a person's level of experience in the above-mentioned areas. This plant is adding 80K sq. ft. of manufacturing space to include two new tableting lines and three packaging lines, and this growth will continue. Good location offers very moderate cost of living and quality of life.
Prime career opportunity to move into a management/ownership position.
- BS or MS Degree in Civil/Structural Engineering
- PE registration; SE preferred
- 5-10+ years of experience with building design and seismic analysis
- Experience in diverse projects - higher education, commercial, institutional, industrial
- Evaluation and reinforcing of existing facilities and dsigning new facilities
- Strong background in building client relationships
- Experience developing business and bringing in revenue
- Experience mentoring younger team members
- Strong communication skills
ASSOCIATE DIRECTOR OF COMPENDIAL AFFAIRS - New Jersey - To $140K
Lead the Compendial (USP/EP/JP) review and submission processes as well as providing strategic guidance on impact of Compendial changes to Global Testing standards and documentation for QC testing of all company-manufactured products. This oversite includes new product launches, scale-ups, CMC guidance from a QC perspective and training of subordinate staff in the above-mentioned areas. Qualified candidates will have a strong analytical QC background to include at least five years of supervisory/managerial experience and ten total years of pharmaceutical industry QC experience, a BS degee (advanced degree preferred) in Chemistry, Biological Sciences or Engineering.
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All positions require U.S. Citizenship or Green Card. Those listed are only a few of our current needs. U.S. residents only.
VALIDATION MANAGER - Ohio - To $125K
Requires BS in Engineering, or Life Sciences, + 3 years management experience. Strong knowledge of cGMP, validation, manufacturing processes, automated process control/monitoring systems, quality systems, engineering design fundamentals, and regulatory agency requirements.
Responsible for leading Validation department in establishing both validation and re-validation policies/programs for multiple-site aseptic manufacturing operation. Oversee a wide range of activities assuring that processes, systems, facilities and equipment comply with accepted GMP utilizing a life-cycle approach.
QUALITY ASSURANCE SYSTEMS MANAGER- North Carolina - To $100K
Responsible for implementation, management, and maintenance of policies, procedures, and systems that ensure quality compliance to applicable standards, regulatory requirements and customer contracts. Quality systems include investigations/deviations, Corrective Action/Preventive Actions (CAPAs), change control, customer and consumer complaints, and Annual Product Reviews (APRs). Provide leadership to ensure all documentation is created, reviewed, approved, and retained in accordance with established procedures and regulatory compliance requirements. Develop, implement, and maintain Quality systems including investigations, CAPAs, document control, change control, customer and consumer complaints, APRs. Work closely with other departments and customers to ensure timely and thorough investigations. Work with Manufacturing to establish CAPAs addressing root cause. Perform final QA review of CAPAs, investigations, and change control. Communicate appropriately with customers in accordance to approved Quality Agreements. Support third party audits as required. Manage and mentor direct reports. Assist in managing the QA Systems budget. Develop, monitor, and publish appropriate KPIs. Publishes Monthly Metrics Reports. Maintain the IQS Training database. Completes the internal audit schedule and ensures the audits are completed. Ensure timely response to customer and patients complaints. Requires (4) year degree in a scientific field and 5+ years of experience in a comparable regulated manufacturing environment. Must have a minimum of 3 years in a supervisory role. Knowledge of current GMP.
Manufacturing and other positions on Page 2.
SENIOR STRUCTURAL ENGINEER - Oregon - To $80K
BUILDING ENVELOPE PROJECT MANAGER - Virginia - To $100K
Engineering and architectural consulting firm needs a qualified building envelope expert. This is a very interesting opportunity to join a growing firm and advance your career. Requirements:
- BS in Engineering
- 5-8+ years of experience with an emphasis in building science, energy performance of buildings, and building enclosure technology
- Project management background
- Minimum 3 years experience performing Whole Building Air Tightness Testing
- Certified Infrared Thermographer is a plus
- Technical expertise in roofing, waterproofing, and air barrier systems
- Ability to perform peer reviews and evaluate the use of materials and critique specifications
- Strong technical, written, and verbal communication skills
- Ability to work proactively in solving complex problems on existing structures
- Background in working with clients and bringing in repeat business
- Ability to work in the field and travel outside local area