Technical Associate Groton, CT
Groton, MA - USA
Job Summary
Why Patients Need You
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 Pfizers 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.
What You Will Achieve
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).
It is your hard work and focus that will help in making Pfizer ready to achieve new milestones and help patients across the globe.
How You Will Achieve It
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. OpsTrakker)
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
Additional Qualifications/Responsibilities
Qualifications
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
Bachelors 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
PHYSICAL/MENTAL REQUIREMENTS
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.
NON-STANDARD WORK SCHEDULE TRAVEL OR ENVIRONMENT REQUIREMENTS
Role requires a Groton site presence.
Flexibility to work off-shift and weekends are required.
Work Location Assignment: On Premise
The salary for this position ranges from $24.22 to $40.36 per addition this position offers eligibility for overtime weekend holiday and other pay premiums depending on the work schedule and the Companys policies. We offer comprehensive and generous benefits and programs to help our colleagues lead healthy lives and to support each of lifes moments. Benefits offered include a 401(k) plan with Pfizer Matching Contributions and an additional Pfizer Retirement Savings Contribution paid vacation holiday and personal days paid caregiver/parental and medical leave and health benefits to include medical prescription drug dental and vision coverage. Learn more at Pfizer Candidate Site U.S. Benefits (). Pfizer compensation structures and benefit packages are aligned based on the location of hire. The United States salary range provided applies only to the United States - Connecticut - Groton location.
Relocation assistance may be available based on business needs and/or eligibility.
Required Experience:
IC
About Company
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