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Job Openings

Openings are listed for the following disciplines:
Quality Assurance / Quality Control (3)
Operations Management (1)
Validation (1)
Engineering (6)

Quality Assurance / Quality Control
QA Associate III
 
JOB SUMMARY:
This function is responsible for supporting the daily activities related to laboratory operations. Functions include discrepancy review, procedure review, maintenance work order review, qualification/data integrity review, and method transfer/qualification review. This function thresholds events to Team Leaders and Senior Associates when they are outside of the area of responsibility.

The position will perform general QA work, using their ability as a skilled contributor in completing tasks where judgment is required in resolving problems and making recommendations. Works on problems of a diverse scope where analysis and problem solving is required. Applies job related skills and understanding of policies and standards in completing tasks.

EDUCATION & EXPERIENCE:
Requires a Bachelor’s degree in a scientific discipline or equivalent with a minimum of 4 - 5 years’ experience in a Quality Assurance role in the pharmaceutical industry ideally with a background supporting QC functions preferred. Will consider substitution of relevant work experience in an alternate Quality role in lieu of QA requirement.

Location  Midwest
Consultant  Andy Ellis

Manager, QA (Laboratories)
 
Provides quality oversight to the Chemistry & microbiology laboratories and product transfer by supporting all work. Work in partnership with the aforementioned groups to produce quality work in compliance with all applicable regulations.

- Review/approve deviations, OOS's, OOT's, EE's, and change controls.
- Perform audits of the chem & micro labs.
- Review/approve protocols, investigative studies, raw data and reports.
- Establish and control quality programs to ensure conformance and compliance to company policies and regulatory standards.
- Leads, manages, and participates in quality projects and teams to implement improvements to the processes, facilities, and equipment quality system infrastructure to meet regulatory requirements.

EDUCATION & EXPERIENCE:
- Minimum BS and 10+ years experience in pharma or biotech industry.
- Knowledge of GxP's for testing and release of pharmaceutical products.
- Experience with equipment qualification and calibration.
- Experience in analytical techniques and validation of methods.
- Prefer experience with aseptic processing.

Location  Northeast
Consultant  Andy Ellis

Senior QA Associate
 
Job Description:
Responsibilities include supporting daily compliance and systems activities. Performs audits (internal and vendor audits), supports change control program, complaints and any customer services related to Documentation Center. Also works with manufacturing to identify resolution to events while working with Quality Management.

The candidate will perform general QA work, using their ability as a skilled contributor in completing tasks where judgment is required in resolving problems and making recommendations. Works on problems of a diverse scope where analysis and problem solving is required. Receives general oversight and guidance on approaches to complete project related tasks. Applies job related skills and understanding of policies and standards in completing tasks.

Qualifications:
- Qualified candidates must have minimum a BS in scientific discipline or equivalent.
- Must have 5-8 years experience in a Quality Assurance role in the pharmaceutical industry; preferably with parenteral and oral dosage forms.

Location  Midwest
Consultant  Andy Ellis

Operations Management
Pharma | Biotech Consultant
 
Focusing primarily on the pharmaceutical industry, our client company provides for improvement programs, management consulting, project management, R&D support, supply chain planning and training for leading companies worldwide.

JOB DESCRIPTION:
The successful candidate for the CONSULTANT opportunity will provide project management leadership and support, participation in lean manufacturing as well as turn around programs with a variety of pharmaceutical clients. This is a unique chance to be part of starting up a new, exciting endeavor for an internationally successful consulting company - an opportunity to gain experience across the breadth of the industry.

QUALIFICATIONS:
We are looking for candidates with strong academic credentials with a BS degree in one of the Engineering, Science or related disciplines as well as a Master's degree in Engineering, Business or Science.

The candidate will either have 1 to 4 years experience in the pharmaceutical or related industry or solid intern assignments during school to accompany the solid academic credentials.

The successful applicant will possess good leadership and interpersonal skills coupled with the ability to work and deliver results in a dynamic and complex environment.

Location  flexible
Consultant  Phil Ellis

Validation
Lead Validation Engineer - Solid Dose
 
The Lead Validation Engineer is responsible for writing, executing, and reporting validation protocols and other relevant documentation. Other validation lifecycle documentation responsibilities may include User Requirement Specifications (URS), Design Qualification (DQ), installation qualification (IQ), operational qualification (OQ), performance qualification (PQ), cleaning validation, and process validation in support of the equipment, utilities, facilities, products, and processes. The position also requires the use of Risk Assessment tools and the execution of Formal Challenges (Requalifications) and time-based assessments where appropriate. This person will also have responsibilities in the areas of process engineering and improvement, interfacing with Process Development and Manufacturing.

Qualifications:
5 - 8 years relevant experience in pharmaceutical validation area with experience in validation of equipment and facilities for manufacture of oral dosage forms .
Consistently demonstrated validation proficiency with advanced knowledge of equipment qualification (IQ/OQ/PQ), cleaning and process validation.

Location  Midwest
Consultant  Lee Douglas

Engineering
Packaging Engineer
 
The Packaging Engineer position will operate as an internal partner to the operations, supply chain and R&D organizations by directly leading packaging activities in support of product development, brand alignment, process improvement and commercial operation objectives.

Key Responsibility Areas:
Strategic Leadership: Oversee the complete packaging development process and lead the corporate packaging rationalization. Develop proactive strategies to mitigate packaging challenges and optimize packaging supply base.

Operational Efficiencies: Participate in product introduction teams and work to implement cost saving and waste reduction initiatives. Manage multiple vendors/projects simultaneously to meet corporate objectives and lead packaging improvement initiatives.

Technical Expertise: Design globally robust packaging options through a thorough review of engineering drawings. Establish specifications, implement testing plans and manage the creation of corporate branded graphics requirements.

Quality Management and Control: Lead the development of and adherence to a comprehensive quality review process for packaging components, including, but not limited to: Standard Operating Procedures and appropriate vendor review.

EDUCATION & EXPERIENCE:
Bachelor’s degree in Material Science, Engineering, Chemistry or related field and at least 6 years of experience in the Pharmaceutical industry in a packaging role.
Effective Communication skills as apparent in the ability to concisely convey an idea, suggestion or question (technical or logistical) to an individual, team, or management; patience; transparency; respectful cooperation with individuals at all levels and different disciplines.
Thorough understanding of and experience working with regulatory and packaging standards (e.g. FDA, ISO, ASTM, and/or ISTA).
Experience with various materials used in packaging oral/topical dosage forms (e.g. tablets, capsules, powders, solutions, creams, lotions, ointments, foams, etc.).
Basic serialization process knowledge.

Location  NC
Consultant  John Lee

Principal Engineer/Scientist - Process Development
 
Job Description:
The positions serves as the site’s Oral Solid Dosage (OSD) platform leader and reports directly to the Sr. Director of Process Development. Responsibilities include management and oversight of multiple early and late stage development projects and support personnel.

Job Functions:
Demonstrates technical expertise in OSD technology and methodologies.
Lead site related process development, scale-up, commercialization and tech transfer responsibilities Collaboratively develop project strategies to meet CMC objectives including design, write and oversee execution of development protocols to support project related activities. Conclude activities with appropriate technical reports to support regulatory submissions Provide leadership to a team of engineers, and technicians supporting Process Development and Clinical Manufacturing activities.
Communicate project status to department and site heads via written and oral communications.

Qualifications:
Experience as a CMC or technical leader prioritizing and managing experimental strategies and communications to senior leadership.
Knowledgeable and proficiency in the design and manufacturing of OSD forms at development and commercial scales
Technical background in Formulation and Process Development of solid dosage forms, specifically; wet/dry granulation, direct compression (single and bilayer) and pan coating.
Knowledge in effective strategies to develop, scale-up and transfer complex R&D processes to Clinical and Commercial Manufacturing.
Working knowledge of Quality by Design and industry trends with Process Analytical Technologies Strong problem solving and analytical skills Working knowledge of statistics; classical, experimental al designs, and process controls Excellent verbal and written communication skills with experience communicating both up and down the organization. Strong technical report writing experience is required.
The desire to work in small, collaborative technical groups in a dynamic, fast-paced, work environment. PhD and 8+yrs, MS and 15+yrs, BS and 20+yrs experience in area of oral solid dosage pharmaceuticals industry with a degree in Engineering or a related field of study

Location  Midwest
Consultant  John Lee

Process Engineer
 
Job Description:
Seeking an experienced Process Engineer to join our team. This position will provide support and assistance in the manufacture of pharmaceutical products for commercial and clinical supplies. Key duties include: scale-up and transfer of oral solid dosage formulations/processes to production facility, design and recommend equipment purchases, write and execute equipment specification and commissioning protocols. Troubleshoot automated equipment for pharmaceutical formulation and packaging. Identify and implement process/equipment improvements (utilizing Change Control systems) to reduce waste and increase process reliability.

Qualifications:
Bachelor's degree; scientific discipline including Engineering or equivalent field. Minimum of 2+ years working experience in oral solid dose pharmaceutical engineering experience or 5+ years pharmaceutical engineering experience.

Technical Knowledge/Skills Needed:
*Thorough mechanical and chemical engineering knowledge as it applies to general process systems and equipment, as well as oral solid dosage drug process systems and equipment.
*Thorough knowledge of automated control systems.
*Thorough knowledge of computer systems operation and software.
*Thorough knowledge of cGMP, OSHA, EPA and FDA facility requirements and regulations.
*Thorough knowledge of chemistry, statistics, equipment design, process control and process scale-up.
*Knowledge of oral solid dose pharmaceutical operations and equipment validations.
*"Hands-on" ability to install and troubleshoot instrumentation and equipment.
*Ability to troubleshoot and maintain manufacturing systems, equipment and processes.
*Ability to author high quality technical protocols/reports (Engineering Studies, commissioning protocols, summary reports, equipment specifications and SOPs.
*Ability to specify and size manufacturing systems, equipment and process equipment.
*Ability to gown for clean room operations.
*Ability to read, understand and accurately follow company SOPs and guidelines.

Location  Midwest
Consultant  John Lee

Senior Engineer - Process Development
 
The key duties of this role are to be the technical leader in late stage small molecule scale-up. The role will be responsible commercial start-up efforts as well as providing support for investigations and identifying process optimization opportunities within commercial operations.

This role is expected to have a strong lab/pilot plant presence: design and execute statistical studies with a focus on process understanding & robustness, interpret and present data, participate in cross-functional development teams, and author technical reports.
Provide technical leadership for start-up of new commercial process lines.
Utilize theoretical and practical expertise to troubleshoot and resolve technical issues with experimental studies or commercial operations.
Identify and implement process improvements into on-going commercial operations with emphasis on yield improvement and reducing process variability.
Generate documentation to support process design and implementation activities within a cGMP environment.
Support FDA pre-approval and post-approval inspections by serving as technical expert for development and processing operations.
Present, where appropriate, technical data to internal or external audit groups and commercial partners.
Build strong relationships with internal and external stakeholders and take advantage of these relationships to identify new opportunities.
Ensure all company and departmental policies and procedures are adhered to and follow cGMPs/cGLPs.

QUALIFICATIONS:
PhD in Chemical/Mechanical Engineering and 5+ years of experience or MS degree and 10+ years of experience. Significant experience in development through GMP commercial batch manufacture, and scale-up/optimization of pharmaceutical products is required.

Experience:
Minimum 5 years of experience in process development, process engineering or related commercial scale-up/manufacturing in the pharmaceutical industry
Experience in leading/executing product development programs for early phase development through commercial validation/launch
Experience in technology transfer of process to commercial facilities
Demonstrated technical expertise for developing new and existing technology based pharmaceutical processes, ensuring a high level of technological competency
Experience in a Process Development environment using PAT and a fundamental understanding of Quality by Design methodology in developing GMP processes Sterile and/or aseptic processing experience preferred but not required

Location  Midwest
Consultant  Tina Nicks

Lead Facilities Engineer
 

Responsible for supporting the operation of the facility by assisting in troubleshooting/optimization of plant systems, designing and implementing OE initiatives, and implementing departmental capital projects such as upgrades to existing facilities and the installation of process and utility equipment to meet business requirements.

Monitor and support all equipment operations of the facility
Provide third tier support for troubleshooting of plant systems
Represent department on project teams for large scale expansions.
Develop, conduct and document test methods for facility systems troubleshooting and validations.
Implement capital projects such as upgrades to existing facilities and the installation of process and utility equipment to meet business requirements
Assist QA group with excursion investigations.
Assist maintenance with facility systems operation, preventive maintenance, and specification and procurement of replacement equipment, spare parts and maintenance supplies.
Write, review and approve operations and equipment SOPs.
Assist with deviation determinations and final analysis.
Assist in maintaining controlled CAD facility and systems drawings.
Assist management with product scale-up, facility and product costs and facility modification and expansion considerations.
Remain current on industry and FDA engineering standards and trends.

EDUCATION & EXPERIENCE:

BS in Chemical or Mechanical Engineering
5-10 years of industrial and/or pharmaceutical facility design, start-up and/or operations required;
10 years aseptic manufacturing, Oral Solid Dose or powder filling background preferred.

Location  MIdwest
Consultant  Andy Ellis

Process Engineer
 
JOB SUMMARY:
Qualified candidates will provide process engineering support and expertise to Engineering, Production, Laboratory, Validation, Automation and Maintenance to support sterile manufacturing processes improvements and projects. This includes but is not limited to:

 

  • Provide assistance for technical transfers from laboratory to full scale manufacturing.
  • Modifications to existing processes or adding new processes that will improve process safety, reduce plant operational costs and product quality.
  • Provide expertise in diagnosing and correcting major operational problems and evaluate equipment process and automation sequences for proper control and compliance within specification.
  • Support customer bid proposals and develop process flow diagrams, identify process, facility and safety gaps with cost effective technical solutions. Develop cost estimate, implementation timing with assumptions, and alternatives to be considered.
  • Specify, purchase and manage the installation of sterile process equipment.
  • Prepare process flow sheets, energy balances, equipment specifications, material balances, etc. to provide sufficient information for Project Engineering in all aspects of project delivery.
  • Provide daily process engineering support to Production on operating problems and to maintenance/plant engineering on equipment performance and materials problems.
  • Provide technical recommendations to permit plant operation within state & federal requirements.

EDUCATION & EXPERIENCE:
-Must have a B.S. degree in Engineering and 4 years experience in the Pharma environment.
-Must have experience in a sterile product manufacturing environment.

 

Location  North Carolina
Consultant  John Lee