Operations Supervisor

WuXi AppTec•Middletown, DE

49d

About The Position

The Operations Supervisor is responsible for ensuring operational activities are carried out in compliance with GMP regulations, hygiene rules, and safety standards. They must ensure adherence to the established production plan while following procedures defined by the pharmaceutical site’s quality system. They will also be responsible for supervising operators and technicians during operational steps. The Operations Supervisor manages and plans GMP cleaning of production areas. Throughout the site construction project phase, the Project Team operates at a rapid pace, managing large-scale and intricate construction and engineering tasks. In this start-up-like environment, the pace is fast, and changes are constant. Adaptability, proactivity, and a willingness to embrace uncertainties are essential. The successful incumbent will thrive on taking initiative, excel at wearing multiple hats, and can switch roles swiftly as circumstances evolve. Collaboration is critical at this dynamic setting, with open communication and a team-first attitude driving success. After the site is operationalized, the position will be leading the Site Support Team to ensure smooth site administrative operations in collaboration with internal and external parties.

Requirements

A minimum of a bachelor's or associate degree with over 6 years of experience in manufacturing site operations.
Working knowledge of manufacturing and R&D operations.
Proven experience in leading and managing a team.
Proficiency in handling local codes and regulations while maintaining international standards.
Highly self-motivated individual capable of working with minimum guidance.
English language proficiency.
Strong knowledge and understanding of OSD processes and procedures and possesses the ability to develop, write and implement operating procedures, work instructions and SOPs from the ground up, ensuring compliance with quality, safety, and regulatory requirements.
Strong knowledge of GMP environment and solid understanding of the pharmaceutical industry, especially in blending, encapsulation, powder compression, and other oral dosage manufacturing processes.
Versatile, organized, rigorous, and an effective communicator with excellent interpersonal skills for teamwork.
Natural leadership, able to share expertise, technical knowledge, and experience to develop the team.
Strong management skills.
Proficient in basic IT tools (Word, Excel, PowerPoint) and ERP systems; able to use them for presentations and reporting.
Proactive in proposing and implementing work organization improvements.
Strong problem-solving skills.
Able to communicate activity progress and issues encountered.
Capable of leading continuous improvement projects with support departments.
Strong sense of responsibility.
Ability to manage projects.
Comfortable giving presentations to groups.
Knowledge of various packaging processes in dry formulation.
Willing to share knowledge and train new employees and operators on packaging equipment.

Nice To Haves

Strong knowledge of GMP environment and solid understanding of the pharmaceutical industry, especially in blending, encapsulation, powder compression, and other oral dosage manufacturing processes.
Versatile, organized, rigorous, and an effective communicator with excellent interpersonal skills for teamwork.

Responsibilities

Serve as the focal point for supporting the Project Team members in relation to operations activities by demonstrating a proactive approach and the ability to anticipate needs.
Coordinate and orchestrate site visits for process equipment vendors for the installation and qualification activities.
Assists in the execution of process equipment testing and startup activities along with develop necessary operational procedures.
Collaborate with internal and external stakeholders to initiate and manage 3rd party services for GMP areas.
Communicate with external partners, contractors, government departments, and other stakeholders on a variety of different documents and agreements as required.
Act as a dedicated member of the Project Team, supporting project execution and taking on responsibilities as assigned by the Site Head.
Plan work and supply needs.
Communicate and explain work instructions.
Train or ensure training of staff on procedures (as the Job Qualified Trainer).
Assign workstations, lead, and coordinate team activities.
Troubleshoot technical issues and make necessary adjustments (with support services if needed).
Operate production lines when permanent operators are absent.
Maintain team cohesion and motivation.
Propose and implement improvements in work organization.
Review production packaging records before Quality Assurance review.
Serve as the main contact point during audits in the area.
Ensure execution of industrial batch packaging operations in GMP environments while meeting the established schedule.
Ensure compliance with hygiene, environmental, and safety (EHS) rules and guidelines.
Check, record, and complete pre-established work documents to ensure traceability of performed operations (batch records completed per GMP standards).
Draft technical documents necessary for equipment operation (user and cleaning instructions, etc.) and other documentation required for packaging operations.
Open deviations in the quality IT system and ensure timely closure.
Perform and follow up on CAPA actions in the quality IT system.
Manage the company responsible for GMP cleaning of production areas and establish cleaning schedules in collaboration with them, according to production constraints.
Participate in qualification/validation of packaging production equipment.
Maintain packaging line indicators and communicate them to the team.
Collaborate with EHS to assess risks and perform risk analyses.
Promote continuous improvement within the team.
Maintain a healthy and safe working environment in controlled areas and ensure compliance with applicable laws and rules.
Ensure staff (including temporary and short-term contracts) are properly informed of risks and trained to act accordingly.
Promote safe behaviors and practices, verify EHS rules are implemented and followed.
Immediately report all incidents and near misses to the EHS department, participate in investigations, and identify preventive measures to avoid recurrence.