Why Patients Need You

Everything we do, every day, is in line with an unwavering commitment to the quality and the delivery of safe and effective products to patients. Our science and risk-based compliant quality culture is innovative and customer oriented. Whether you are involved in manufacturing, testing, or compliance, your contribution will directly impact patients.

What You Will Achieve

The successful candidate will assume professional responsibilities within the API (Active Pharmaceutical Ingredient) compliance group. Primary responsibilities include managing all cleaning and process validation activities for their assigned manufacturing areas. In addition, the candidate must interface regularly with customer and regulatory auditors and take a lead role in evolving compliance programs with the API area.

Key responsibilities include:

• Develop strategies and documents for cleaning and process validation of API equipment and products in compliance with site SOPs and regulatory guidance.

• Support 24/7 plant operations with timely responses to complex validation concerns or cleaning failures

• Defend the validation programs and strategies to customer and regulatory auditors.

• Support API wide compliance initiatives.

How You Will Achieve It

Functional/Technical Knowledge: Knowledge of basic discipline. Limited knowledge of industry practices and standards. Focus is on overseeing defined processes.

Problem Solving and Innovation: Provide solutions to a wide range of difficult/complex problems. May refer to precedents and policies. Able to gather, analyze and interpret information and identify cause and effect relationships. Solutions are imaginative, practical, thorough, and in-line with organization objectives. Able to adapt and respond positively to situations and people in order to meet changing work unit priorities. Identify cost improvement projects. Operate within established HR policies and guidelines.

Discretion, Latitude, Level of Independence: Work under only general direction. Participate in determining objectives of assignments. Independently determine and develop the approach to solutions. Work is reviewed upon completion for adequacy in meeting objectives. Administer policies & procedures that affect individual colleagues in assigned unit.

Impact and Organizational Contribution: Contribute to the completion of specific programs and projects. Ensure that projects are completed on schedule following established procedures and schedules. Erroneous decisions or recommendations or failure to achieve results might cause delays in program schedules and result in the allocation of more resources. Monitor and manage the efforts of colleagues to achieve delivery of short-term goals. Lead and motivate others, generating commitment and a shared sense of purpose.

Time Span of Work: Projects and tasks covering one month to three months deliverables or milestones. Progress of work measured monthly.

Qualifications
Must-Have

• Applicant must have a High School Diploma (or Equivalent) and 6 years of relevant experience OR an associates degree with 4 years of experience OR a bachelor's degree with 0+ years of experience.

• Computer Skills: Microsoft Applications, willingness to learn and utilize SAP, QTS, QPSNT, PDOCS, eQMS.

• Physical Demands: Frequent time in the manufacturing area around equipment with moving parts, stair climbing, roof access.

• Work Environment: Office environment, with frequent time in the manufacturing. Use of hearing and eye protection is required.Certificates, Licenses or Registrations: None

• Technical Writing: Demonstrated ability to write effectively with emphasis on technical content.

• Regulated Environment Acumen: Understanding of how regulatory standard and guidance documents as well as evolving cGMPS impact pharmaceutical production.

  
Nice-to-Have

• Experience in Chemistry, Micro-biology, or chemical, industrial, environmental, biomedical, or mechanical engineering.

PHYSICAL/MENTAL REQUIREMENTS

• Physical Demands:  Frequent time in both manufacturing and office environments. The manufacturing environment includes equipment with moving parts.  Must be able to perform gowning requirements for entry in the manufacturing areas.

• Requires lifting, sitting, standing, walking, stair climbing and roof access.  Must be available to support 24/7 – 365 operation. 

• Work Environment:  Office environment, with frequent time in the manufacturing areas.  Possible exposure to high noise environments, solvents, and pharmaceutical ingredients.  Use of hearing and eye protection is required. 

NON-STANDARD WORK SCHEDULE, TRAVEL OR ENVIRONMENT REQUIREMENTS

Must be available to support 24/7 – 365 operation.

Relocation support available

Work Location Assignment: On Premise

Other Job Details:

• Last Date to Apply for Job: April 12, 2023

• Eligible for Employee Referral Bonus

Relocation assistance may be available based on business needs and/or eligibility.