Biopharmaceutical Manufacturing Associate

Job Description

Job Description

Job Title: 1st Shift CGMP Biomanufacturing Training Specialist

Location: Madison, WI (726 Heartland Trail)

Duration: Temp - 6 months

Pay Range: $26.81/hr $29.81/hr (W2)

 

Job Description

We are seeking a 1st Shift CGMP Biomanufacturing Training Specialist to join our dynamic team. The ideal candidate will have strong experience in cGMP biomanufacturing training, cleanroom operations, and SOP compliance and a proven ability to design, deliver, and evaluate training that drives regulatory compliance and operational readiness.

 

Responsibilities:

Track and monitor training, providing timely and accurate metrics and reports to the Training Manager to ensure compliance.

Actively lead in-person training sessions on SOPs, cGMP processes, compliance, and Environmental Health and Safety.

Assist with needs assessments to determine training requirements and address learning issues or new educational needs.

Develop and administer qualifications and evaluations to measure training effectiveness within Manufacturing.

Design and develop training for job-specific tasks, SOPs, FDA cGMP, EHS regulations, and general work skills.

Revise training materials based on assessment and evaluation outcomes.

Partner with Subject Matter Experts to define needs, target audiences, and performance standards.

Support floor operations with safety improvements and on-the-floor manufacturing support.

Assist Quality Assurance with SOP training as needed and ensure accuracy of training records.

Communicate relevant decisions, policies, and information that affect performance and results.

Maintain the effectiveness of the Quality System related to cGMP and training requirements.

Support cleanroom housekeeping and adherence to 5S standards.

Assist in executing equipment qualification and validation protocols as required.

Work the scheduled shift with flexibility for off-shift coverage as required and participate in team meetings.

 

Required Skills & Qualifications:

B.S./B.A. in Biology, Chemistry, or related scientific field.

1–2 years of related laboratory experience.

Experience in Biomanufacturing or Pharmaceutical/Medical Device environments.

Cleanroom, aseptic technique, and general lab equipment experience.

Knowledge of cGMP, Good Documentation Practices, and GLP with adherence to SOPs.

Experience operating, maintaining, and troubleshooting biomanufacturing equipment.

Proficiency with MS Excel, Word, and related applications; accurate basic math skills.

Ability to work in ISO 6/7/8 cleanroom environments and provide on-the-floor support.

 

Preferred Skills:

Commercial BioManufacturing or Pharmaceutical/Medical Device experience.

Prior ISO 6/7/8 cleanroom experience with dedicated training responsibilities.

Familiarity with TrackWise, ComplianceWire, or similar electronic training and tracking systems.

 

Company Description

About BCforward:

Founded in 1998 on the idea that industry leaders needed a professional service, and workforce management expert, to fuel the development and execution of core business and technology strategies, BCforward is a Black-owned firm providing unique solutions supporting value capture and digital product delivery needs for organizations around the world. Headquartered in Indianapolis, IN with an Offshore Development Center in Hyderabad, India, BCforward’s 6,000 consultants support more than 225 clients globally.

BCforward champions the power of human potential to help companies transform, accelerate, and scale. Guided by our core values of People-Centric, Optimism, Excellence, Diversity, and Accountability, our professionals have helped our clients achieve their strategic goals for more than 25 years. Our strong culture and clear values have enabled BCforward to become a market leader and best in class places to work.

BCforward is an equal opportunity employer.

Company Description

About BCforward:\r\n\r\nFounded in 1998 on the idea that industry leaders needed a professional service, and workforce management expert, to fuel the development and execution of core business and technology strategies, BCforward is a Black-owned firm providing unique solutions supporting value capture and digital product delivery needs for organizations around the world. Headquartered in Indianapolis, IN with an Offshore Development Center in Hyderabad, India, BCforward’s 6,000 consultants support more than 225 clients globally.\r\n\r\nBCforward champions the power of human potential to help companies transform, accelerate, and scale. Guided by our core values of People-Centric, Optimism, Excellence, Diversity, and Accountability, our professionals have helped our clients achieve their strategic goals for more than 25 years. Our strong culture and clear values have enabled BCforward to become a market leader and best in class places to work.\r\n\r\nBCforward is an equal opportunity employer.