Manufacturing Ops Support Specialist I/II/III - Commercial

JOB SUMMARY

The Manufacturing Operations Support Specialist - Commercial 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 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. The level of this position will be determined based on the selected candidate's qualifications, skills, and relevant experience

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 1-8+ 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

COMPENSATION

This position may be filled at either the Specialist I, II or III level, depending on the qualifications and experience of the selected candidate. The anticipated annual salary range is: $65,000-$105,000. Actual hourly rate and level will be determined based on relevant experience, skills and education.

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