Technical Operations Contractor - II (Associate)

Immediate need for a talented Technical Operations Contractor - II (Associate). This is a 09+ Months contract opportunity with long-term potential and is located in West Point, PA (Onsite). Please review the job description below and contact me ASAP if you are interested.

Job ID: 24-18572

Pay Range: $38 - $43/hour. Employee benefits include, but are not limited to, health insurance (medical, dental, vision), 401(k) plan, and paid sick leave (depending on work location).

Key Responsibilities:

• Establish and manage project schedules and timelines
• Determine project resource requirements and works with stakeholders to gain support needed from subject matter experts.
• Stakeholders may include Operations, Quality, Regulatory, Analytical and Process Development functions.
• Responsible for stakeholder engagement, communication, and risk escalation.
• Develop and execute change control inclusive of change definition, risk assessments, impact assessments, task execution, implementation, and support of associated regulatory filings.
• Author/ update technical and manufacturing documents necessary for process design/ definition, engineering studies, process demonstrations, and validation.
• Design/conduct experimental protocols as needed using the Technical Operations lab facilities and/or production equipment at full scale.
• Examine an issue from diverse perspectives (safety, compliance, automation, equipment, process, and people) in order to best understand and resolve the root cause.
• Consistent application of standardized work, engineering, and process tools (i.e. TrackWise, IPI, MS Project, Excel).
• Provide technical support to manufacturing for problems and issues.
• Work as a team member on complete manufacturing investigations, process improvement and/or validation projects.

Key Requirements and Technology Experience:

• Bachelor's Degree in Engineering or Science
• Required Experience and Skills:
• Minimum of two (2) years of work experience in the biological/ pharmaceutical/chemical manufacturing industry
• Experience in biologics, vaccine, or bulk sterile manufacturing facilities in a process or validation support role.
• Minimum of six (6) months work experience with cGMPs, Change Control, CFR, and other appropriate regulations to vaccine manufacturing.
• Strong understanding of Change Control and Project management
• Demonstrated ability to work both independently and as a part of a team
• Strong technical problem-solving abilities
• Demonstrated effective written and verbal communication skills
• Strong collaboration skills
• Familiarity or experience with aseptic Vaccine Manufacturing Operations or Equipment
• Experience with introduction of process changes to a licensed process

Our client is a leading Healthcare organization and we are currently interviewing to fill this and other similar contract positions. If you are interested in this position, please apply online for immediate consideration.

Pyramid Consulting, Inc. provides equal employment opportunities to all employees and applicants for employment and prohibits discrimination and harassment of any type without regard to race, colour, religion, age, sex, national origin, disability status, genetics, protected veteran status, sexual orientation, gender identity or expression, or any other characteristic protected by federal, state or local laws.