Positions Overview

Associate Technician

REQUIRED QUALIFICATIONS:

• High School Diploma or equivalent
• Candidates may be required to work in an aseptic gowning environment to perform job duties. Aseptic gowning requires that all skin and hair are covered through wearing the following:  Beard/moustache cover, hair net, hood and face mask, goggles, jumpsuit, gloves and boots.
• Candidates are willing and able to lift 50 lbs.
• Multiple shifts are available.  Shift requirements will vary based on the position you are selected for.  Shift preferences will be requested if selected for interview.

PREFERRED QUALIFICATIONS:

• BioWork Certificate (working in an FDA regulated industry)

Technician

REQUIRED QUALIFICATIONS:

• High School Diploma or equivalent.
• Candidates may be required to work in an aseptic gowning environment to perform job duties. Aseptic gowning requires that all skin and hair are covered through wearing the following:  Beard/moustache cover, hair net, hood and face mask, goggles, jumpsuit, gloves and boots.
• Candidates are willing and able to lift 50 lbs.
• Multiple shifts are available.  Shift requirements will vary based on the position you are selected for.  Shift preferences will be requested if selected for interview.

PREFERRED QUALIFICATIONS:

• Associate or Bachelor degree in a technical field with 2 years experience in the pharmaceutical industry and/or within an aseptic clean room environment
• BioWork Certificate (working in and FDA regulated industry)

Senior Technician

REQUIRED QUALIFICATIONS:

• High School Diploma or equivalent with 2 years experience in working in the pharmaceutical industry and/or within aseptic clean room environments OR Bachelor degree in a technical field.
• Candidates may be required to work in an aseptic gowning environment to perform job duties. Aseptic gowning requires that all skin and hair are covered through wearing the following:  Beard/moustache cover, hair net, hood and face mask, goggles, jumpsuit, gloves and boots.
• Candidates are willing and able to lift 50 lbs.
• Multiple shifts are available.  Shift requirements will vary based on the position you are selected for.  Shift preferences will be requested if selected for interview.
• Experience with batch record execution, including good documentation practices.

PREFERRED QUALIFICATIONS:

• Demonstrated 1-2 years of leadership experience
• BioWork Certificate (working in an FDA regulated industry)
• Certified Yellow Belt
• Proficiency in the use of SAP in a manufacturing setting
• Execution of Paper or Electronic Batch Records

Lead Technician

REQUIRED QUALIFICATIONS:

• High School Diploma or equivalent with 4 years experience working in the pharmaceutical industry and/or within aseptic clean room environments. OR
• Bachelor degree in a technical field with 2 years experience working in the pharmaceutical industry and/or within aseptic clean room environments.
• Candidates may be required to work in an aseptic gowning environment to perform job duties. Aseptic gowning requires that all skin and hair are covered through wearing the following:  Beard/moustache cover, hair net, hood and face mask, goggles, jumpsuit, gloves and boots.
• Candidates are willing and able to lift 50 lbs.
• Multiple shifts are available.  Shift requirements will vary based on the position you are selected for.  Shift preferences will be requested if selected for interview.

PREFERRED QUALIFICATIONS:

• Demonstrated 2-4 years of leadership experience
• Experience training others and/or leading hands-on or instructor-led training
• BioWork Certificate (working in an FDA regulated industry)
• Certified Yellow Belt/Green Belt
• Proficiency in the use of SAP in a manufacturing setting
• Review of Paper or Electronic Batch Record

Associate Specialist, QA

REQUIRED QUALIFICATIONS:

• Bachelor degree preferred; Candidates with an Associate degree will be considered pending relative experience; Minimum of an internship or one (1) year of relevant post-degree work experience in GMP-related field, including Technical, Engineering, Quality, or Operations
• Knowledge and exposure to fundamental theories, principles, and concepts in the Quality Assurance discipline , including the knowledge and understanding of pharmaceutical operations systems
• Technical writing capabilities and be able to compile straightforward investigations and procedures
• One to four years pharmaceutical industry exposure
• Comprehends and applies regulatory/compliance requirements, including GMP, NDA, and related regulations, and has the ability to interpret those regulations for implementation in the workplace

Specialist, QA

REQUIRED QUALIFICATIONS:

• Associate's degree (preferably in Science or Engineering) with 4+ years in a GMP pharma manufacturing facility 
• Bachelor of Arts or Science degree preferred (preferably in Science or Engineering) with 2+ years in a GMP pharma manufacturing facility 

Required Experience and Skills

• Advanced knowledge and ability to operate information systems (SAP COMET and TrackWise preferred) required to complete job responsibilities with the ability to generate data and reports from these systems. 
• Minimum of three (3) years in a GMP pharmaceutical manufacturing facility with either direct involvement in Quality functions supporting release and compliance activities or indirect involvement in Quality fun

Associate Specialist, Engineering

REQUIRED QUALIFICATIONS:

• Bachelor of Science Degree in Engineering or Life Sciences

Required Experience and Skills

• Effective technical problem-solving abilities
• Demonstrated effective written and verbal communication skills; ability to influence both peers and management in consensus
• Strategic and effective collaboration and leadership skills

Preferred Experience and Skills

• Bulk upstream and/or downstream vaccine processes within a cGMP environment
• Facility, equipment, and process start-up in a sterile GMP environment
• Validation in support of GMP process demonstration (IQ/OQ/PQ)

Specialist, Engineering

REQUIRED QUALIFICATIONS:

• Bachelor’s degree or higher in Engineering or Computer Science

Required Experience and Skills: 

• Minimum 2 years of experience in a regulated industry

Preferred Experience and Skills:

• Direct experience with Allen Bradley PLC (or equivalent), MES (Manufacturing Execution System), and PI. 
• Aseptic processing/sterile manufacturing experience and Lean Manufacturing /Six Sigma methodology is desired.