Genezen is hiring: Manufacturing Specialist II in Lexington

JOB SUMMARY

The MFG Specialist in this role will be part of a cohesive team responsible for Deviation investigations, CAPAs, and Change Controls for all phases of manufacturing. The Manufacturing Specialist uses expert knowledge of cGMP regulations and project management to ensure manufacturing readiness and compliance. The incumbent will also support equipment, documentation and process operations improvement initiatives within Manufacturing. The MFG Specialist works independently with minimal supervision and direction. Performs work that consistently requires independent decision making and the exercise of independent judgment and discretion.

This position is located in Lexington, MA and reports to the MFG Compliance and Improvement Manager.

ESSENTIAL JOB FUNCTIONS

• Practices and promotes safe work habits and adheres to safety procedures and guidelines
• Utilizes manufacturing process knowledge and investigation skill to identify and resolve manufacturing issues, improve process operations and affect positive change.
• Performs root cause analysis on Manufacturing quality events and leads investigations for minor and major quality events.
• Identifies and drives Manufacturing corrective and/or preventative actions.
• Provide Manufacturing support for tech transfers
• Attend Change Control Review Meetings to present and resolve questions related to changes. Prepare assessments on changes impacting manufacturing.
• Participates on cross functional teams to drive complex manufacturing operations changes or improvements
• Supports document revisions and/or document management including batch production records and manufacturing procedures
• Performs training with staff on the floor
• Provides expertise for processing technology (chromatography, filtrations, digital systems, etc…)
• Participates in cross-functional equipment and operational process improvement while teaming with Engineering, Validation, Quality Assurance, Quality Control, Facilities, and Manufacturing Science and Technology
• Lead by example by demonstrating current good manufacturing practices, complying with standard operating procedures, and maintaining compliant manufacturing documentation.
• Performs work that consistently requires independent decision making and the exercise of independent judgment and discretion, with periodic management guidance
• Reviews the work of others and provides feedback
• Creates and presents trending and metrics reports
• Participates in equipment start-up, commissioning, and validation activities
• Works in a manner that requires consistent exercise of discretion and judgment

SPECIAL JOB REQUIREMENTS

• Adaptability required as work schedule may change based on business needs
• Criminal background check required
• Other duties as assigned

KNOWLEDGE, SKILLS AND EXPERIENCE

EDUCATION / CERTIFICATIONS / LICENSES

Essential/Desired

BS or MS degree in biology, biochemistry, molecular biology, or related field, or equivalent experience

Essential

ON-THE-JOB EXPERIENCE

Minimum 2-3 years related industry experience in related field

Essential

Experience with owning, investigation and writing deviations, creating and executing CAPAs, and writing and managing Change controls

Essential

Experience in biomanufacturing unit operations (USP and/or DSP)

Essential

Experience performing root cause analysis using practices, such as Event & Causal Factor Charting, Kepner-Tregoe Problem Analysis, and the basic Quality Improvement Tools (e.g., Pareto Chart, Control Chart, and Process Map, etc.)

Essential

Able to adhere to company internal and regulatory (EMA, FDA) policies, processes and procedures

Essential

SKILLS / ABILITIES

Ability to apply systems thinking as part of a problem-solving

Essential

Demonstrates industrial empathy when working with stakeholders

Essential

Detail oriented and able to self-organize

Essential

Able to communicate in a professional way on diverse levels and channels

Essential

Takes the initiative to own and resolve issues

Essential

Good technical writing and oral communication skills

Essential

PHYSICAL DEMANDS

While performing the duties of this job, the employee is required to meet the following physical demands:

Work Environment

• Frequently required to work in a GMP clean room environment with personal protective equipment/aseptic gowning
• Regularly required to work around equipment and typical utilities seen in pharmaceutical facilities
• Occasionally exposed to moving mechanical parts; high, precarious places; toxic or caustic chemicals; hazardous waste; and risk of electrical shock
• Occasionally exposed to loud noise levels
• Spending time on the floor during activity execution is required

Movement

• Frequently required to stand; sit; walk; balance; stoop; kneel; crouch; use hands to finger, handle, or feel; reach with hands and arms
• Occasionally required to walk; climb or balance; and stoop, kneel, crouch, or crawl

Lifting

• Frequently lift and/or move up to 25 pounds
• Occasionally lift and/or move up to 40 pounds

Vision

• Frequently utilize close vision and the ability to adjust focus
  Communication
• Frequently required to communicate by talking, hearing, using telephone and e-mail