About this role
I. Manufacturing Department Overview: To provide a cGMP compliant manufacturing process and continuously improve the pharmaceutical manufacturing environment at Catalent St. Petersburg.
Create a workplace that is safe, clean, environmentally friendly, employee friendly, highly productive, efficient and of sufficient capacity to support the forecasted demand as predicted by Catalent Pharma Solutions. II. Basic Function: This position is critical in ensuring that manufacturing processes are executed in strict compliance with Good Manufacturing Practices (GMP), regulatory requirements, and internal quality standards.
The Production Supervisor must demonstrate strong leadership, a commitment to compliance, quality and safety and the ability to foster a culture of continuous improvement and accountability III. Specific Activities, and Responsibilities: General Management Ensure proficiency of all Standard Operating Procedures (SOPs) within their area of responsibility. Supervisors are accountable for verifying that SOPs are accurate, practical, and aligned with current operations, and for escalating any gaps or inconsistencies.
They must ensure that procedures are clearly understood, executable by the team, and continuously improved as needed. Responsible for monitoring on-time completion of all operator training requirements. Organize and communicate standard and overtime schedules for team members.
Attend and actively participate in various meetings as required Lead and supervise a team of manufacturing operators in the execution of daily production activities. Define priorities, daily expectations, and assignments. Monitor and manage production schedules, resource allocation, and workflow to meet batch release timelines.
Ensures manufacturing plans are met in terms of quality, efficiency, volumes and labor usage, as applicable. Provide coaching, training, and performance feedback to team members to promote professional growth and operational excellence. Conduct routine GMP audits and Gemba walkthroughs, deviation investigations, and support CAPA implementation.
Collaborate with cross functional teams (i.e. Quality Assurance, Engineering, and Validation teams) to ensure smooth and compliant operations. Actively participate in cross-functional meetings, providing updates, insights, and recommendations related to manufacturing performance and compliance.
Oversee documentation of manufacturing activities, including SOPs, batch records, logbooks, and deviation reports. Drive a culture of safety, quality, and continuous improvement within the production environment. Identify and develop high-potential team members through mentorship, training programs, and career development planning.
Ensure adherence of Catalent Critical 10 Principles. Technical and Maintenance Identify and implement process improvements to enhance efficiency, reduce waste, and improve product quality. Work closely with the Engineering and Maintenance teams to ensure equipment reliability, preventive maintenance, and timely repairs.
Monitor equipment performance and escalate recurring issues for resolution. Support equipment qualification, validation, and change control processes. Recommend and assist in the implementation of new technologies or upgrades to improve manufacturing capabilities.
Participate in technical troubleshooting and continuous improvement initiatives (e.g., Lean, Six Sigma). Human Resources Participate in the selection, onboarding, and retention of qualified operators. Foster a positive and collaborative work environment, promoting open communication and team engagement.
Maintain accurate and up-to-date documentation of employee performance, including coaching and feedback records. Identify and support developmental opportunities for team members, including cross-training and career advancement. Administer corrective actions and disciplinary measures in accordance with company policies and procedures, when necessary.
Quality Ensure strict adherence to SOPs and GMP through regular training and supervision. Conduct routine facility and equipment inspections to maintain proper state of repair. Monitor and enforce preventive maintenance and calibration schedules.
Promote a culture of accountability to reduce human error and improve documentation practices. Perform quality and readiness checks walkthroughs to proactively identify and resolve compliance risks. Collaborate with cross-functional teams to address quality issues and implement corrective actions.
Scheduling and Reporting Able to adjust to changing production schedule. Ensures On-Time Delivery. Monitors and submits productivity metrics, as required.
Completes shift hand-offs with both the incoming and outgoing shifts. Safety Primary contact on the shift for safety/security issues. Proposes, implements, and enforces safety improvements.
Conducts safety evaluations. Ensure work areas are safe for all employees. Ensure employees conduct their work in a safe manner.
Ensures that all safety measures are taken and are compliant with the Safety Policies of the Company. IV. Knowledge Requirements: Education or Equivalent: Bachelor’s degree preferred.
3+ years related experience in the pharmaceutical industries preferred. Prior Supervisory experience a plus. Training and/or equivalent combination of education and experience will be considered.
Must have excellent English verbal and written communication skills. Intermediate to advanced PC skills, including knowledge of Catalent’s software packages preferred. Must be flexible in days of work, able to work 12hour shifts Knowledge/Skills Requirements: PC skills, including training on Catalent’s software packages.
Ability to read, analyze, and interpret general business periodicals, professional journals, technical procedures and financial reports. Vision requirements include ability to differentiate color (Pass the Ishihara Color Vision Screening) and obtain 20/30 acuity in both far and near vision with or without corrective lenses. For Catalent’s in-house screening, the acceptable score is to identify at least 4 of 6 numbers in the circles.
Ability to write reports, business correspondence, and standard operating procedures. Ability to effectively present information and respond to questions from groups of managers, customers, and regulatory agencies Physical/Mental Requirements: Ability to work effectively under pressure to meet deadlines. Individuals may be required to sit, stand, walk regularly and occasionally lift to 15 pounds; no lifting greater than 44.09 pounds without assistance.
Be accessible to the manufacturing floor and office staff and to use required office equipment. Specific vision requirements include reading of written documents and use of computer monitor screen frequently. Business Environment: The individual’s primary workstation is located on the manufacturing floor.
To perform this job successfully, an individual must be able to perform each duty satisfactorily. The requirements listed above are representative of the knowledge, skill, and/or ability required. Reasonable accommodation may be made to enable individuals with disabilities to perform the essential functions.
This job description reflects the general duties of the job but is not a detailed description of all duties which may be inherent to this position. Catalent may assign reasonably related additional duties to individual employees, consistent with company policy. Catalent offers rewarding opportunities to further your career!
Join the global drug development and delivery leader and help us bring over 7,000 life-saving and life-enhancing products to patients around the world. Catalent is an exciting and growing international company where employees work directly with pharma, biopharma and consumer health companies of all sizes to advance new medicines from early development to clinical trials and to the market. Catalent produces more than 70 billion doses per year, and each one will be used by someone who is counting on us.
Join us in making a difference. personal initiative. dynamic pace. meaningful work. Visit Catalent Careers to explore career opportunities. Catalent is an Equal Opportunity Employer, including disability and veterans.
If you require reasonable accommodation for any part of the application or hiring process due to a disability, you may submit your request by sending an email, and confirming your request for an accommodation and include the job number, title and location to DisabilityAccommodations@catalent.com . This option is reserved for individuals who require accommodation due to a disability. Information received will be processed by a U.S.
Catalent employee and then routed to a local recruiter who will provide assistance to ensure appropriate consideration in the application or hiring process. Notice to Agency and Search Firm Representatives: Catalent Pharma Solutions (Catalent) is not accepting unsolicited resumes from agencies and/or search firms for this job posting. Resumes submitted to any Catalent employee by a third party agency and/or search firm without a valid written & signed search agreement, will become the sole property of Catalent.
No fee will be paid if a candidate is hired for this position as a result of an unsolicited agency or search firm referral. Thank you. Important Security Notice to U.S.
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An employer who violates this law may be subject to criminal penalties and civil liability. Consistent with Massachusetts law, Catalent does not require or administer lie detector tests as a condition of employment or continued employment.