Associate Director – TS/MS Validation

Role Summary

Associate Director – TS/MS Validation. Responsible for staffing, training, and leadership of the Technical Services/Manufacturing Science TS/MS validation group, with focus areas including cleaning validation, sterilization validation, filter validation, controlled temperature storage qualification, and verification of equipment, facilities, and utilities.

Responsibilities

• Staff and lead the TS/MS validation group; support day-to-day validation activities and 3‚Äì6 month planning.
• Provide input, guidance, and oversight to other validation types as needed.
• Understand scientific principles for manufacturing parenteral drug products, device assembly and packaging, including interactions of chemistry, equipment, aseptic processes, and container closure systems.
• Build a diverse and capable TS/MS organization; support cleaning, sterilization, and filter validation, plus qualification of equipment, facilities, and utilities.
• Provide technical guidance to the TS/MS group.
• Participate in strategies supporting Continuous Improvement, RCA, and FMEA.
• Support site inspection readiness and execution; interact with Regulatory Agencies during inspections.
• Manage external contracts/resources and project management resources as needed.
• Develop and maintain validation program documents including SOPs and Master Plans.
• Review and approve GMP documentation (procedures, deviation investigations, technical reports, change controls, regulatory submissions, validation master plans, protocols, and summary reports).
• Lead TS/MS technical projects to improve start-up, process control, yield, product quality, and productivity.
• Collaborate with cross-functional teams to implement TS/MS validation objectives and meet business and quality goals.
• Network with global and other parenteral sites to share best practices and support strategic planning.
• Maintain a safe working environment and participate in safety initiatives.

Qualifications

• BS, MS, or Doctorate in Mechanical Engineering, Pharmaceutical Sciences, Biochemical Engineering, Chemical Engineering, or related scientific discipline.
• Minimum 1 year of management or leadership experience with cross-functional teams.
• Minimum 5 years of regulated industry experience.
• Previous experience with aseptic manufacturing.

Skills

• Strong technical aptitude; ability to train and mentor others.
• Excellent interpersonal, written, and oral communication skills across organizational levels.
• Solid understanding of regulatory requirements from agencies such as FDA, EMEA, and OSHA.
• Experience supporting cGMP manufacturing (operations, TS/MSAT, QA, etc.).
• Facility or area startup experience.
• Equipment qualification and process validation experience.
• Experience with highly automated equipment.
• Experience with deviation and change management systems (e.g., MasterControl).

Education

• As listed in Qualifications (degree(s) in relevant fields).

Additional Requirements

• Role is Monday‚ÄìFriday; must be flexible to support production schedules, shutdowns, and occasional extended hours or off-hour work.