Technical Associate - Groton, CT

Job Description

ATTENTION MILITARY AFFILIATED JOB SEEKERS - Our organization works with partner companies to source qualified talent for their open roles. The following position is available to Veterans, Transitioning Military, National Guard and Reserve Members, Military Spouses, Wounded Warriors, and their Caregivers. Unless specifically stated otherwise, this role is "On-Site" at the location detailed in the job post.

Our breakthroughs would not make it to the hands of patients without our pharmaceutical manufacturing team. We rely on a team of dedicated and agile members, who understand the importance and impact of their role in Pfizer’s mission. Patients need colleagues like you who take pride in their work and always look to improve outcomes. You will help to ensure that patients and physicians have the medicines they need, when they need them.

We are seeking a motivated individual for the role of Technical Associate (SDM Operations Group T2) in our Solid Dose Manufacturing (SDM) facility in Groton, CT. The focus in the SDM will be on batch-process manufacturing for tablet and capsule formulations. The successful candidate will provide day to day manufacturing support meeting timelines, schedules, and operational quality standards in alignment with current GMP guidelines for manufacturing activities for clinical drug product supplies.

Primary responsibility includes performing daily activities which include cleaning, equipment set-up and pharmaceutical manufacturing processing for oral solid dosage forms with a focus on compliance and continuous improvement. The successful candidate must demonstrate strong teamwork dynamics when interfacing with various groups (e.g., Operations, Quality, Tech Support, GWE).

• Manufacture solid dosage forms (tablets and capsules) for developmental, stability and clinical studies/supplies.
• Set-up, operate, clean, and maintain complex pharmaceutical manufacturing equipment associated with Solid Dose processing using closed transfer systems.
• Implement cGMP procedures and safe handling techniques for solid dosage processing.
• Generate, assist and execute documentation associated with solid dosage manufacture such as, working batch record documentation, Logbooks, labels and in-process run sheets.
• Proficient and use of digital tools (electronic logs, forms and batch records) within dynamic and paperless systems (ex. Ops Trakker).
• Generate, assist and execute equipment lifecycle documentation such as;
  Qualification Protocols, Periodic Reviews, and Change Control documentation.
• Create and revise Standard Operating Procedures (SOP) for cGMP manufacturing equipment and activities.
• Assist with Quality Compliance reviews and investigations focused on root causal factors as well as identifying Corrective and Preventative actions.
• Complete activities identified as operator care tasks associated with the maintenance and operation of complex novel pharmaceutical manufacturing equipment.
• Complete activities associated with the operation and maintenance of the SDM cGMP manufacturing space.
• Sound understanding of computational mathematic tools and formulas (i.e. ability to calculate yield, batch accountability, operational ranges, coating efficiency and percentages).
• Identify, own and lead continuous improvement-based projects using Lean Manufacturing Techniques.

High School/GED

Must-Have

• High School Diploma or GED.
• 2+ years of cGMP experience.
• Demonstrated experience in a biotechnology manufacturing or laboratory environment.
• Operational knowledge of multiple computerized systems.
• Familiarity with Production Control Systems, Enterprise Resource Planning Systems and other business systems.
• Maintains a safe work environment.
• Demonstrated capability to work as a team member in a matrix development team.
• Excellent oral and written communication skills.
• Strong computer skills in Microsoft Office required, especially MS Word, MS Excel.

Nice-to-Have

• Bachelor's Degree
• Knowledge of Pharmaceutical solid-dose formulation, novel processing equipment and/or Commercial Processing standards.
• Mechanical aptitude and desire to execute hands on manual labor

Standing, walking, bending, climbing, reaching, and lifting upward of 55 pounds may be required. Personal Protective Equipment such as gloves, a full Tyvek suit and breathable air or filtering face piece may be required.